ClinicalTrials.gg
Sign In
Not yet recruitingNCT07811232Updated Sep 10, 2026

A Study of AL58805 in Advanced, Metastatic GYN, STS or Breast Cancers

A Phase 1/2 interventional study of AL58805 and AL8326 in Endometrial Neoplasms, Soft Tissue Sarcoma (STS) and Breast Neoplasms, sponsored by Advenchen Pharmaceuticals, LLC.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Advenchen Pharmaceuticals, LLC. · Phase 1/2, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 1/2
Study type
Interventional
Enrollment
138
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 714 studies in Endometrial Neoplasms with a site in United States — 197 open to participants now, 287 under way, 22 of them phase 3. Endometrial Neoplasms · United States.

Planned enrollment
175th of 590
138 · median 60
Started
2026
with 44 others
Phase 1/2
85 of 714
43 open now
Primary completion
2030-09
later than 272 of 286 live
Registered
704th of 714
by date

Among the 714 studies in Endometrial Neoplasms with a site in United States, this one is the 175th largest by planned enrollment of the 590 interventional ones that give a count, is one of 45 that started in 2026, is one of 85 in phase 1/2, reaches primary completion later than 272 of the 286 other live ones, and was the 704th registered.

Endometrial Neoplasms

1,426 studies on the registry are indexed under Endometrial Neoplasms; 471 are open to participants now.

Browse Endometrial Neoplasms studies →

Open to participants now

197 of the 714 studies in Endometrial Neoplasms with a site in United States are open now. Recruiting first, the newest first:

192 more — sign in →

All 197 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 357 Endometrial Neoplasms studies recruiting now, 267 (75%) set no upper age limit and 54 (15%) stop at 75 or younger; 26 take children under 18; 23 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 714 studies in Endometrial Neoplasms with a site in United States, or all of them as a file.
02

Study summary

This phase 1b/2a study evaluates AL58805, an oral investigational drug that blocks PI3K and mTOR signaling, in combination with one of three anticancer treatments: AL8326 (veonetinib), eribulin, or fulvestrant. Adults with recurrent, advanced, or metastatic endometrial cancer, cervical cancer, soft tissue sarcoma, or breast cancer may be eligible after at least one prior standard treatment has failed or could not be tolerated and no effective standard treatment option remains.

In phase 1b, small groups of participants will receive different doses of AL58805 with a fixed dose of the partner treatment to identify a recommended combination dose based on dose-limiting side effects. In phase 2a, disease-specific groups will receive the selected combination dose to estimate the objective response rate and further evaluate duration of response, progression-free survival, overall survival, safety, pharmacokinetics, and exploratory tumor biomarkers. Protocol treatment may continue for up to 12 months, with continued treatment beyond 12 months possible for participants who remain clinically benefiting and receive investigator and sponsor approval.

Read the detailed description

AL-GB-805 is a global, multicenter, open-label, nonrandomized phase 1b/2a study of oral AL58805, a dual PI3K/mTOR inhibitor, combined with AL8326 (veonetinib), eribulin, or fulvestrant in adults with recurrent, advanced, or metastatic endometrial cancer, cervical cancer, soft tissue sarcoma (STS), or breast cancer for whom at least one prior standard treatment has failed or was not tolerated and no standard effective option remains.

Phase 1b uses a standard 3+3 dose-escalation/de-escalation design to select a regimen-specific recommended combination dose (RCD). AL58805 begins at 10 mg and may be increased to 20 mg or reduced to 5 mg based on dose-limiting toxicities (DLTs). Cohort A combines AL58805 with AL8326 40 mg in 28-day cycles; Cohort B combines AL58805 with eribulin 1.4 mg/m² intravenously on Days 1 and 8 of each 21-day cycle; and Cohort C combines AL58805 with fulvestrant 500 mg intramuscularly on Days 1, 15, and 29 and monthly thereafter in 28-day cycles. The RCD is the highest evaluated AL58805 dose at which fewer than 33% of evaluable participants experience a DLT during the first treatment cycle.

Phase 2a evaluates each regimen at its RCD. Cohort D includes separate endometrial cancer, cervical cancer, and STS groups receiving AL58805 plus AL8326. Cohort E includes separate STS and breast cancer groups receiving AL58805 plus eribulin. Cohort F includes an HR-positive or other eligible breast cancer group receiving AL58805 plus fulvestrant. Each disease-specific group initially enrolls 17 participants. Under the protocol-specified Simon two-stage design, a group with no objective responses stops for futility; a group with one or more objective responses may enroll 18 additional participants for a total of 35.

Tumor response is assessed by the investigator or local radiologist according to RECIST 1.1 at baseline and approximately every 8 weeks beginning on Cycle 3 Day 1. A complete response or partial response is confirmed by repeat imaging 4 to 6 weeks later. Treatment continues until disease progression, unacceptable toxicity, intercurrent illness that prevents safe treatment, withdrawal, sponsor discontinuation, or completion of 12 months of protocol treatment, whichever occurs first. Treatment beyond progression may be allowed when the investigator and sponsor determine that clinical benefit continues and urgent alternative intervention is not being delayed.

Participants who remain without progression and continue to benefit may receive study treatment beyond 12 months with investigator and sponsor approval under the protocol continued-access provisions or may later transition to a separate post-trial access protocol. Safety is monitored through the final study visit 4 to 5 weeks after the last study dose, and unresolved related adverse events and serious adverse events are followed until resolution or stabilization. Long-term follow-up includes vital status and subsequent anticancer therapy every 3 to 6 months.

03

Conditions studied

  • Endometrial Neoplasms
  • Soft Tissue Sarcoma (STS)
  • Breast Neoplasms
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- Subjects must meet all of the following inclusion criteria to be eligible for this study:

  1. Age ≥ 18 years.

  2. proven diagnosis of:

    1. Pathologically confirmed recurrent or solid tumors such as Endometrial cancer, Cervical cancer, STS and Breast cancer;

    2. Failure of at least 1 prior line of standard therapy (disease progression after treatment or intolerable treatment toxicities);

      - Patients with mismatch repair deficient/microsatellite-instability high tumors must have received a prior /PD-L1 therapeutic agent.

    3. No standard and effective treatment available.
  3. Have defined by 1.1 confirmed by CT or MRI scan within 28 days of enrollment.
  4. of ≥ 3 months at the time of enrollment.
  5. Able to take orally administered study medication.

  6. Have adequate baseline function and performance status within 28 days of enrollment:

    1. Bone marrow function: (ANC) ≥ 1,500/mm3, ≥75,000/mm3 and ≥ 9g/dl.
    2. Renal function: creatinine ≤ 1.5 x institutional upper limit normal () or if creatinine is > 1.5 x ULN, must be > 50 mL/min.
    3. Hepatic function: ≤ 1.5 x ULN or ≤ 3.0 x ULN for subjects with Gilbert Syndrome; No liver metastasis, and ALT ≤ 2.5 × ULN; When liver metastasis occurs, AST and ALT ≤ 5.0 × ULN.
    4. Coagulation profile: (INR) is ≤ 1.5 and an aPTT or PTT \< 1.2 x ULN.
    5. performance ≤ 2
    6. (LVEF) ≥ 50%
  7. No gastrointestinal diseases that affect drug absorption, such as malabsorption.
  8. Women of must agree to use measures starting 1 week before C1D1 until 4 weeks after the last dose of study treatment and have a negative serum pregnancy test within 28 days of enrollment. The patient must be non-lactating; if a female patient has not yet reached menopause (menopause is defined as the cessation of menstruation for at least 12 consecutive months, with no other causes), and has not undergone sterilization (removal of the ovaries and/or uterus), she is considered to be fertile. Her sexual partner should use medically approved contraception during the treatment period and for 4 weeks after the treatment ends;
  9. Provide written and authorization permitting release of Protected Health Information.
  10. Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures.

Exclusion criteria

Exclusion Criteria:

  • Subjects presenting with any of the following will not be included in the study:

    1. Treatment with an agent within 28 days of enrollment.
    2. Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 28 days (42 days in cases of mitomycin C, nitrosourea, lomustine) prior to enrollment.
    3. Concomitant treatment with strong inhibitors or inducers of , CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life- threatening medical condition that required it.
    4. Known allergy or intolerance to investigational drugs (e.g.AL58805, AL8326, eriblin, fulvestrant, etc.) and . (For example, who have had intolerable adverse reactions such as local injection site pain or systemic discomfort after application of fulvestrant should be excluded.)
    5. Other invasive , with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer presents within the last 5 years prior to enrollment or whose previous cancer treatment contraindicates this protocol therapy.
    6. Myocardial infarction or unstable angina within 6 months prior to enrollment; (NYHA) Grade II or greater congestive heart failure; serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease.
    7. Pre-existing uncontrolled hypertension as documented by two baseline blood pressure readings taken at least five minutes apart, defined as systolic BP >150 mm Hg or diastolic BP>90 mm Hg pressure.
    8. ≥ 480 msec on screening per Fridericia's formula.
    9. History of or existing risk factors for Torsades de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
    10. Concurrent use of concomitant medications that prolong the QT/QTc interval.
    11. History of significant vascular disease (e.g. aortic aneurysm, aortic dissection, peripheral vascular disease).
    12. Patients with severe (COPD) in acute exacerbation, severe pulmonary fibrosis (such as idiopathic pulmonary fibrosis with rapid disease progression), etc.

    13. History or evidence upon physical examination of central nervous system (CNS) disease including primary brain tumor; seizures not controlled with standard medical therapy; and history of cerebrovascular accident (CVA, stroke), (TIA), or subarachnoid hemorrhage within 6 months of enrollment.

      a. Subjects with CNS tumors may participate in this study if the subject is > 28 days from therapy completion (including radiation and/or surgery), is clinically stable at the time of study enrollment, and is not receiving therapy.

    14. History of neurological or psychiatric disorder, such as dementia, which in the investigator's assessment may prevent protocol compliance.
    15. Serious, non-healing wound, ulcer or bone fracture.
    16. Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to C1D1 (a major surgical procedure is defined as requiring general anesthesia).
    17. Diabetes with poor blood sugar control. (If a patient with diabetes requires long-term use of insulin or hypoglycemic drugs, with no history of hypoglycemic drug dose adjustment in the past 1 month, they may be considered for inclusion after investigator assessment, even if their is between 7.5% and 8.0%.)
    18. History of pancreatitis; history of renal disease that includes confirmed glomerulonephritis, proven tubulointerstitial nephritis, crystal nephropathy or other renal insufficiencies.
    19. Proteinuria on urinalysis within 28 days of enrollment. Subjects discovered to have a urine protein of 1+ on dipstick or ≥ 30 mg/dl at baseline should undergo a 24-hour urine collection and demonstrate \< 1000 mg protein per 24 hours or spot urine protein (mg/dL) to creatinine (mg/dL) ratio must be \<1.0 to allow participation in the study.
    20. , uncontrolled hypokalemia, hypomagnesaemia, and/or hypocalcaemia.
    21. Hemoptysis within 3 months prior to enrollment.
    22. Acute or chronic liver disease, active hepatitis A, B, or C with known cirrhosis or liver dysfunction.
    23. Active bacterial infections requiring IV antibiotics (excluding uncomplicated urinary tract infection).
    24. Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
    25. History of non-malignant gastrointestinal bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months prior to enrollment that in the opinion of the investigator may place the subject at risk of side effects on an anti-angiogenesis product.
    26. Intra-abdominal abscess within the last 3 months of enrollment.
    27. Ascites or pleural effusion (CTCAE5.0 ≥2)
    28. History of difficulty swallowing, malabsorption, active partial or complete bowel obstruction, or other chronic gastrointestinal disease or condition that may hamper compliance and/or absorption.
    29. Anticoagulation therapy with warfarin. Subjects treated with heparin, low molecular weight heparin, or any other anticoagulant may be included provided the subject has been on a stable therapeutic dose of the anticoagulant for at least 14 days prior to enrollment.
    30. Known history of infection (HIV) with viral load is detectable.
    31. -positive patients with HBV DNA ≥ 104 copies or ≥ 2000IU/mL, antiviral and liver protection treatment should be performed first, and they can be enrolled only when HBV-DNA ≤ 104 copies/mL (2000IU/mL), and continue to take antiviral drugs, monitor liver function and hepatitis B virus load; antibody positive and HCV-RNA positive.
    32. The investigator deems that the subject is not suitable to participate in this study.
Terms in these criteria, in plain language(35)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
138 participants (estimated)

Study arms

  • Experimental
    P1b-Cohort A: (AL58805 + AL8326 Endometrial/Cervical/STS cancer, RCD-A)

    This cohort evaluates the safety and tolerability of AL8326 (40 mg) in combination with AL58805 (10 mg) in a 3+3 DLT evaluation design. If DLT occurs, AL58805 will be reduced to 5 mg; If no DLT occurs at 10 mg, it will be escalated to 20 mg.

    Drug: AL58805 · Drug: AL8326

  • Experimental
    P1b-Cohort B: (AL58805 + Eribulin, Soft Tissue Sarcoma/Breast Cancer, RCD-B)

    This cohort evaluates the safety and tolerability of Eribulin (1.4 mg/m²IV; 21 day-cycles of local standard) in combination with AL58805(10 mg). If DLT occurs, AL58805 will be reduced to 5 mg; If no DLT occurs at 10 mg bid, it will be escalated to 20 mg.

    Drug: AL58805 · Drug: Eribulin

  • Experimental
    P1b-Cohort C: (AL58805 + Fulvestrant, HR+/other Breast Cancer, RCD-C)

    This cohort evaluates the safety and tolerability of Fulvestrant (500 mg IM) in combination with AL58805 (10 mg). If DLT occurs, AL58805 will be reduced to 5 mg; If no DLT occurs at 10 mg, it will be escalated to 20 mg.

    Drug: AL58805 · Drug: Fulvestrant

  • Experimental
    P2a-Cohort D: (AL58805 + AL8326, Endometrial/Cervical/STS cancer)

    This cohort evaluates the safety and efficacy of AL8326 + AL58805 at RCD-A (determined from Cohort A) in patients with advanced Endometrial (n=17), Cervical (n=17) and STS cancer (n=17) (≥2nd line, age ≥18). Treatment continues until PD or intolerability.

    Drug: AL58805 · Drug: AL8326

  • Experimental
    P2a-Cohort E: (AL58805 + Eribulin, Breast cancer/Soft Tissue Sarcoma)

    This cohort evaluates the safety and efficacy of Eribulin + AL58805 at RCD-B (determined from Cohort B) in patients with STS (n=17) and Breast cancer (n=17) (≥2nd-line, age ≥18). Treatment continues until PD or intolerability.

    Drug: AL58805 · Drug: Eribulin

  • Experimental
    P2a-Cohort F: (AL58805 + Fulvestrant, HR+/other Breast Cancer)

    This cohort evaluates the safety and efficacy of Fulvestrant + AL58805 at RCD-C(determined from Cohort C) in patients with HR+/other Breast cancer (≥2nd-line, age ≥18). Treatment continues until PD or intolerability (n=17). Other breast cancer in phase 1b/2a: HER2-, PIK3CA mutant and PIK3CA Wild-Type etc.

    Drug: AL58805 · Drug: Fulvestrant

Interventions

  • DrugAL58805

    AL58805 is a novel chemical-structure antitumor drug with independent intellectual property rights. It functions as a novel dual-target PI3K/mTOR kinase inhibitor, exhibiting effects such as inhibiting tumor cell growth and proliferation, suppressing tumor nutrient metabolism, and exerting anti-angiogenic activity. By simultaneously inhibiting both PI3K and mTOR, it completely blocks the entire PI3K/AKT/mTOR signaling pathway at relatively low safe doses, thereby enhancing antitumor efficacy.

  • DrugAL8326

    AL8326 is a novel small molecule multi-receptor tyrosine kinase inhibitor, which shows highly selective inhibition of fibroblast growth factor receptor (FGFr1, FGFr2, FGFr3), vascular endothelial growth factor receptor (VEGFr1, VEGFr2, VEGFr3) and Aurora-B.

  • DrugEribulin

    Eribulin Mesylate is a microtubule dynamics inhibitor used in the treatment of certain advanced solid tumors. It works by binding to tubulin, inhibiting the dynamic assembly and disassembly of microtubules, blocking mitosis in cancer cells, and inducing apoptosis.

  • DrugFulvestrant

    Fulvestrant is a class of estrogen receptor antagonist, estrogen receptor downregulation agents for anti-breast cancer treatment.

06

What researchers measure

Primary outcomes

  1. Recommended Combination Dose (RCD)

    Determine the recommended combination dose (RCD) of AL58805 in combination with AL8326, Eribulin, or Fulvestrant based on the incidence of dose-limiting toxicities (DLTs) during Phase 1b. The RCD is defined as the highest evaluated dose level at which fewer than 33% of participants experience a DLT.

    Time frame: 36 months

  2. Objective Tumor Response Rate (ORR)

    Percentage of participants who achieve a Complete Response (CR) or Partial Response (PR) as the best overall tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Time frame: 36 months

Secondary outcomes

  1. Pharmacokinetic endpoint: Time to Maximum Plasma Concentration (Tmax)

    Time from study drug administration to the observed maximum plasma concentration (Tmax) of AL58805, and of AL8326 where applicable, determined from protocol-specified pharmacokinetic sampling.

    Time frame: 36 months

  2. Pharmacokinetic endpoint: Maximum Observed Plasma Concentration (Cmax)

    Maximum observed plasma concentration (Cmax) of AL58805, and of AL8326 where applicable, determined from plasma concentration-time data collected at protocol-specified pharmacokinetic sampling time points.

    Time frame: 36 months

  3. Pharmacokinetic endpoint: Area Under the Plasma Concentration-Time Curve (AUC)

    Area under the plasma concentration-time curve (AUC) of AL58805, and of AL8326 where applicable, calculated from plasma concentration-time data collected at protocol-specified pharmacokinetic sampling time points.

    Time frame: 36 months

  4. Duration of Response (DOR)

    Time from the date of the first documented objective response, defined as Complete Response (CR) or Partial Response (PR), to the date of documented disease progression or death from any cause, whichever occurs first, according to RECIST version 1.1.

    Time frame: 36 months

  5. Progression-Free Survival (PFS)

    Time from Cycle 1 Day 1 (C1D1) to the first documented disease progression or death from any cause, whichever occurs first.

    Time frame: 36 months

  6. Overall Survival (OS)

    Time from Cycle 1 Day 1 (C1D1) to death from any cause.

    Time frame: 36 months

07

Study locations

1 site
08

References and documents

Publications

  • Wen W, Marcinkowski E, Luyimbazi D, Luu T, Xing Q, Yan J, Wang Y, Wu J, Guo Y, Tully D, Han ES, Yost SE, Yuan Y, Yim JH. Eribulin Synergistically Increases Anti-Tumor Activity of an mTOR Inhibitor by Inhibiting pAKT/pS6K/pS6 in Triple Negative Breast Cancer. Cells. 2019 Aug 30;8(9):1010. doi: 10.3390/cells8091010. PubMed 31480338 ↗
  • Gris-Oliver A, Ibrahim YH, Rivas MA, Garcia-Garcia C, Sanchez-Guixe M, Ruiz-Pace F, Viaplana C, Perez-Garcia JM, Llombart-Cussac A, Grueso J, Pares M, Guzman M, Rodriguez O, Anton P, Cozar P, Calvo MT, Bruna A, Arribas J, Caldas C, Dienstmann R, Nuciforo P, Oliveira M, Cortes J, Serra V. PI3K activation promotes resistance to eribulin in HER2-negative breast cancer. Br J Cancer. 2021 Apr;124(9):1581-1591. doi: 10.1038/s41416-021-01293-1. Epub 2021 Mar 15. PubMed 33723394 ↗
  • Lan C, Shen J, Wang Y, Li J, Liu Z, He M, Cao X, Ling J, Huang J, Zheng M, Zou G, Yan H, Liu Q, Yang F, Wei W, Deng Y, Xiong Y, Huang X. Camrelizumab Plus Apatinib in Patients With Advanced Cervical Cancer (CLAP): A Multicenter, Open-Label, Single-Arm, Phase II Trial. J Clin Oncol. 2020 Dec 1;38(34):4095-4106. doi: 10.1200/JCO.20.01920. Epub 2020 Oct 14. PubMed 33052760 ↗
  • Chung HC, Ros W, Delord JP, Perets R, Italiano A, Shapira-Frommer R, Manzuk L, Piha-Paul SA, Xu L, Zeigenfuss S, Pruitt SK, Leary A. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2019 Jun 10;37(17):1470-1478. doi: 10.1200/JCO.18.01265. Epub 2019 Apr 3. PubMed 30943124 ↗
  • Tinker AV, Ellard S, Welch S, Moens F, Allo G, Tsao MS, Squire J, Tu D, Eisenhauer EA, MacKay H. Phase II study of temsirolimus (CCI-779) in women with recurrent, unresectable, locally advanced or metastatic carcinoma of the cervix. A trial of the NCIC Clinical Trials Group (NCIC CTG IND 199). Gynecol Oncol. 2013 Aug;130(2):269-74. doi: 10.1016/j.ygyno.2013.05.008. Epub 2013 May 11. PubMed 23672928 ↗
  • Zhang L, Wu J, Ling MT, Zhao L, Zhao KN. The role of the PI3K/Akt/mTOR signalling pathway in human cancers induced by infection with human papillomaviruses. Mol Cancer. 2015 Apr 17;14:87. doi: 10.1186/s12943-015-0361-x. PubMed 26022660 ↗
  • Tewari KS. Cervical Cancer. N Engl J Med. 2025 Jan 2;392(1):56-71. doi: 10.1056/NEJMra2404457. No abstract available. PubMed 39752299 ↗
  • Monk BJ, Colombo N, Tewari KS, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Li K, Keefe SM, Lorusso D; KEYNOTE-826 Investigators. First-Line Pembrolizumab + Chemotherapy Versus Placebo + Chemotherapy for Persistent, Recurrent, or Metastatic Cervical Cancer: Final Overall Survival Results of KEYNOTE-826. J Clin Oncol. 2023 Dec 20;41(36):5505-5511. doi: 10.1200/JCO.23.00914. Epub 2023 Nov 1. PubMed 37910822 ↗
  • Colombo N, Dubot C, Lorusso D, Caceres MV, Hasegawa K, Shapira-Frommer R, Tewari KS, Salman P, Hoyos Usta E, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Toker S, Li K, Keefe SM, Monk BJ; KEYNOTE-826 Investigators. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer. N Engl J Med. 2021 Nov 11;385(20):1856-1867. doi: 10.1056/NEJMoa2112435. Epub 2021 Sep 18. PubMed 34534429 ↗
  • Motzer RJ, Hutson TE, Glen H, Michaelson MD, Molina A, Eisen T, Jassem J, Zolnierek J, Maroto JP, Mellado B, Melichar B, Tomasek J, Kremer A, Kim HJ, Wood K, Dutcus C, Larkin J. Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial. Lancet Oncol. 2015 Nov;16(15):1473-1482. doi: 10.1016/S1470-2045(15)00290-9. Epub 2015 Oct 22. PubMed 26482279 ↗
  • Matsuki M, Adachi Y, Ozawa Y, Kimura T, Hoshi T, Okamoto K, Tohyama O, Mitsuhashi K, Yamaguchi A, Matsui J, Funahashi Y. Targeting of tumor growth and angiogenesis underlies the enhanced antitumor activity of lenvatinib in combination with everolimus. Cancer Sci. 2017 Apr;108(4):763-771. doi: 10.1111/cas.13169. Epub 2017 Apr 20. PubMed 28107584 ↗
  • Vergote I, Powell MA, Teneriello MG, Miller DS, Garcia AA, Mikheeva ON, Bidzinski M, Cebotaru CL, Dutcus CE, Ren M, Kadowaki T, Funahashi Y, Penson RT. Second-line lenvatinib in patients with recurrent endometrial cancer. Gynecol Oncol. 2020 Mar;156(3):575-582. doi: 10.1016/j.ygyno.2019.12.039. Epub 2020 Jan 17. PubMed 31955859 ↗
  • Makker V, Taylor MH, Aghajanian C, Oaknin A, Mier J, Cohn AL, Romeo M, Bratos R, Brose MS, DiSimone C, Messing M, Stepan DE, Dutcus CE, Wu J, Schmidt EV, Orlowski R, Sachdev P, Shumaker R, Casado Herraez A. Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer. J Clin Oncol. 2020 Sep 10;38(26):2981-2992. doi: 10.1200/JCO.19.02627. Epub 2020 Mar 13. PubMed 32167863 ↗
  • Makker V, Colombo N, Casado Herraez A, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim YM, Guerra EM, Sanli UA, McCormack MM, Smith AD, Keefe S, Bird S, Dutta L, Orlowski RJ, Lorusso D; Study 309-KEYNOTE-775 Investigators. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. N Engl J Med. 2022 Feb 3;386(5):437-448. doi: 10.1056/NEJMoa2108330. Epub 2022 Jan 19. PubMed 35045221 ↗
  • Dutt A, Salvesen HB, Chen TH, Ramos AH, Onofrio RC, Hatton C, Nicoletti R, Winckler W, Grewal R, Hanna M, Wyhs N, Ziaugra L, Richter DJ, Trovik J, Engelsen IB, Stefansson IM, Fennell T, Cibulskis K, Zody MC, Akslen LA, Gabriel S, Wong KK, Sellers WR, Meyerson M, Greulich H. Drug-sensitive FGFR2 mutations in endometrial carcinoma. Proc Natl Acad Sci U S A. 2008 Jun 24;105(25):8713-7. doi: 10.1073/pnas.0803379105. Epub 2008 Jun 13. PubMed 18552176 ↗
  • Chae YK, Ranganath K, Hammerman PS, Vaklavas C, Mohindra N, Kalyan A, Matsangou M, Costa R, Carneiro B, Villaflor VM, Cristofanilli M, Giles FJ. Inhibition of the fibroblast growth factor receptor (FGFR) pathway: the current landscape and barriers to clinical application. Oncotarget. 2017 Feb 28;8(9):16052-16074. doi: 10.18632/oncotarget.14109. PubMed 28030802 ↗
  • Starks DC, Rojas-Espaillat L, Meissner T, Williams CB. Phase I dose escalation study of dual PI3K/mTOR inhibition by Sapanisertib and Serabelisib in combination with paclitaxel in patients with advanced solid tumors. Gynecol Oncol. 2022 Sep;166(3):403-409. doi: 10.1016/j.ygyno.2022.07.005. Epub 2022 Jul 15. PubMed 35843739 ↗
  • Slomovitz BM, Coleman RL. The PI3K/AKT/mTOR pathway as a therapeutic target in endometrial cancer. Clin Cancer Res. 2012 Nov 1;18(21):5856-64. doi: 10.1158/1078-0432.CCR-12-0662. Epub 2012 Oct 18. PubMed 23082003 ↗
  • Cheung LW, Hennessy BT, Li J, Yu S, Myers AP, Djordjevic B, Lu Y, Stemke-Hale K, Dyer MD, Zhang F, Ju Z, Cantley LC, Scherer SE, Liang H, Lu KH, Broaddus RR, Mills GB. High frequency of PIK3R1 and PIK3R2 mutations in endometrial cancer elucidates a novel mechanism for regulation of PTEN protein stability. Cancer Discov. 2011 Jul;1(2):170-85. doi: 10.1158/2159-8290.CD-11-0039. Epub 2011 Jun 7. PubMed 21984976 ↗
  • How JA, Jazaeri AA, Westin SN, Lawson BC, Klopp AH, Soliman PT, Lu KH. Translating biological insights into improved management of endometrial cancer. Nat Rev Clin Oncol. 2024 Nov;21(11):781-800. doi: 10.1038/s41571-024-00934-7. Epub 2024 Aug 28. PubMed 39198622 ↗
  • Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. PubMed 38572751 ↗
  • Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025 Jan-Feb;75(1):10-45. doi: 10.3322/caac.21871. Epub 2025 Jan 16. PubMed 39817679 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2030, 48 months later.

Of 80 phase 1/2 interventional studies under Endometrial Neoplasms, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 54 and three quarters within 106. This study's planned 48 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2026
First posted
Sep 10, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2030
CompletionEst.
Sep 1, 2031
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07811232
Lead sponsor
Advenchen Pharmaceuticals, LLC.
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2030 (estimated)
Completion
Sep 1, 2031 (estimated)
Last update
Sep 10, 2026

Study contacts

Queenie Yang, PhD
Contact
queeniey@advenchen.com
8055301550
Judy Chen
Contact
judc@advenchen.com
Judy Chen
study director · Advenchen Pharmaceuticals, LLC.
Jeffrey A How, MD
principal investigator · UT MD Anderson

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Endometrial Neoplasms →

Other studies from this sponsor

Advenchen Pharmaceuticals, LLC.

Start the discussion