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Not yet recruitingNCT07811297Updated Sep 10, 2026

A Study of Catequentinib Hydrochloride (AL3818) in Endometrial, LGSOC, STS or GBM Cancers

A Phase 1/2 interventional study of AL58805 and AL3818 in Endometrial Neoplasms, Ovarian Neoplasms and Soft Tissue Sarcoma (STS), 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

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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.

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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 the investigational oral drug catequentinib hydrochloride (AL3818), given alone or with AL58805, temozolomide, or lomustine (CCNU), in adults with advanced or metastatic solid tumors. The phase 1b part will identify doses that can be given safely based on side effects during the first treatment cycle. The phase 2a part will estimate whether the treatments shrink non-brain tumors or keep glioblastoma from worsening for at least 6 months.

The study is open label, which means participants and study investigators will know which treatment is given. Tumor response will be assessed with RECIST version 1.1. The study will also evaluate how the investigational drugs move through the body, the duration of tumor response, progression-free survival, overall survival, and treatment safety.

Read the detailed description

AL-GB-900 is an international, multicenter, open-label, nonrandomized phase 1b/2a study of oral AL3818, a fibroblast growth factor receptor and vascular endothelial growth factor receptor tyrosine kinase inhibitor. AL3818 is evaluated as monotherapy and in combination with oral AL58805, a PI3K/mTOR inhibitor, or with the alkylating agents temozolomide or lomustine.

Phase 1b uses protocol-defined 3+3 dose-exploration cohorts to select a monotherapy recommended phase 2 dose (RP2D) and regimen-specific recommended combination doses (RCDs) based on dose-limiting toxicities (DLTs) during the first cycle. Cohort A1 evaluates AL3818 monotherapy in adults with recurrent or metastatic non-small cell lung cancer, small cell lung cancer, soft tissue sarcoma, thyroid cancer, endometrial cancer, low-grade serous ovarian cancer, or breast cancer. Cohort A2 evaluates AL3818 plus AL58805 in endometrial cancer, low-grade serous ovarian cancer, or soft tissue sarcoma. Cohort B1 evaluates an AL3818 monotherapy run-in in glioblastoma, and eligible participants may transition to Cohort B2 for separate dose evaluations of AL3818 plus temozolomide or AL3818 plus lomustine.

Phase 2a evaluates preliminary efficacy and further safety at the selected doses. Cohort C evaluates AL3818 monotherapy in separate endometrial cancer molecular groups (TP53-mutated adenocarcinoma, TP53-associated carcinosarcoma, and TP53-wild-type disease) and in low-grade serous ovarian cancer. Cohort D evaluates AL3818 plus AL58805 in separate endometrial cancer, low-grade serous ovarian cancer, and soft tissue sarcoma groups. Cohort E evaluates AL3818 plus temozolomide and AL3818 plus lomustine in separate glioblastoma groups.

For non-glioblastoma phase 2a groups, the primary activity measure is objective response rate according to RECIST version 1.1. For glioblastoma, the primary activity measure is the proportion of participants alive and progression-free at 6 months according to RECIST version 1.1. Imaging is generally performed at baseline and approximately every 8 weeks. Complete or partial responses are confirmed by repeat imaging 4 to 8 weeks later.

Study treatment may continue for up to 12 months or until disease progression, unacceptable toxicity, withdrawal, intercurrent illness, or sponsor termination. Temozolomide or lomustine is administered for no more than 6 cycles; participants may continue AL3818 afterward if otherwise eligible. Participants who remain without progression and continue to benefit may continue protocol-specified compassionate-care treatment beyond 12 months at the investigator's discretion. The sponsor must reconcile the enrollment arithmetic, the glioblastoma statistical decision rule, and several dose specifications before the record is released.

03

Conditions studied

  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Soft Tissue Sarcoma (STS)
  • Glioblastoma
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 NSCLC, SCLC, STS, Thyroid, Endometrial, LGSOC, GBM and breast cancer (Phase 2a: STS, Endometrial, LGSOC and GBM ); GBM can only have histological confirmation of diagnosis;
      2. Failure of at least 1 prior line of standard therapy (disease progression after treatment or intolerable treatment toxicities); concurrent chemoradiation therapy and chemotherapy such as containing temozolomide will be considered as 1
      3. no standard or effective treatment available.
    3. is not required in phase 1b. Have measurable disease defined by 1.1 (or RANO 2.0 for GBM by MRI) confirmed by CT or MRI scan within 28 days of enrollment in phase 2a.
    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.

    11. For GBM patients only:

      1. Prior therapy with gamma knife or other focal high-dose radiation is allowed, but at least 2 weeks (14 days) must have elapsed from the time of treatment, and the patient must have subsequent histologic documentation of recurrence, unless the recurrence is a new lesion outside the irradiated field.
      2. Prior therapy with Laser Induced Thermal Therapy (LITT) is allowed, but at least 21 days must have elapsed from last LITT, with recovery from all LITT-related toxicities to Grade 1 or less and subsequent histologic documentation of recurrence.
      3. For those patients using the Optune™ device, it will be discontinued at least 14 days before initiating treatment with either study medication, the patient must have recovered from all treatment-related toxicities to Grade 1 or less.
      4. Patients must have a performance scale score ≥ 60.
      5. Maximum dexamethasone dose (or equivalent dose) of 2 mg daily.
      6. The contrast enhancing portion of the tumors must be ≥1.0 cm in diameter.

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, targeted therapies, immunotherapy, or radiotherapy within 28 days (42 days in cases of mitomycin C, nitrosourea, lomustine) prior to enrollment. Prior bevacizumab or other antiangiogenic therapies for phase 2 part of the GBM cohort (however, use of bevacizumab for radiation necrosis or toxicity is allowed unless it is within 28 days 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., AL3818, AL58805, temozolomide, CCNU, etc.) and . (For example, patients who have had severe allergic reactions such as rash or anaphylactic shock after previous use of temozolomide.)
    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 (not applicable for GBM cohorts); 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, mood disorder, etc. which in the investigator's assessment may prevent protocol compliance such as inability of ICF execution.
    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.

    33. For GBM patients only:

      1. Prior treatment with cranial/brain radiation precluding standard of care chemoradiation therapy with concurrent temozolomide for 6 weeks.
      2. , infratentorial disease, spinal cord disease.
      3. Less than 12 weeks from completion of standard chemoradiation with concurrent temozolomide unless the patient has histologically proven tumor recurrence.
Terms in these criteria, in plain language(38)

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.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

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.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

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.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

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.1-A1: Cohort A1 (Monotherapy RP2D determination, Solid Tumors)

    This cohort evaluates the safety and tolerability of oral AL3818 monotherapy (12 mg, 4 days on/3 days off) in a 28-day per cycle for patients with advanced solid tumors such as NSCLC, SCLC, STS, Thyroid, Endometrial, LGSOC, Breast cancer patients who require ≥2nd-line therapy or have no standard of care (SOC) treatment options (age ≥18). A 3+3 design is used to assess dose-limiting toxicities (DLTs), escalate to 14 mg if no DLT or de-escalate to 10 mg if DLT observed, to determine the recommended monotherapy Phase II dose (RP2D). LGSOC patient can use AL3818 for1st line treatment at PI's discretion.

    Drug: AL3818

  • Experimental
    P1b.1-A2: Cohort A2 (Combination therapy RP2D determination, Endometrial, LGSOC or STS)

    This cohort evaluates the safety and tolerability of oral AL3818 (12mg or 10mg, 4 days on/3 days off, based on above RP2D-2mg) in combination with AL58805 (10 mg) in a 28-day per cycle for patients with STS or Endometrial patients. A 3+3 design is used to assess dose-limiting toxicities (DLTs), escalate AL58805 to 20mg if no DLT or deescalate AL3818 to 10 mg if DLT observed, to determine the recommended combination therapy Phase II dose (RP2D). LGSOC patient can use AL3818 for1st line treatment at PI's discretion.

    Drug: AL58805 · Drug: AL3818

  • Experimental
    P1b.2-B1: Cohort B1 (Monotherapy RP2D determination, Glioblastoma)

    This cohort evaluates the safety and tolerability of AL3818 monotherapy (12mg, 4 days on/3 days off) for glioblastoma (GBM) patients. A 3+3 design is used to assess dose-limiting toxicities (DLTs), de-escalate to 10 mg if DLT observed. If no DLT observed, Patients will go next cohort P1b.2-B2 for combination study.

    Drug: AL3818

  • Experimental
    P1b.2-B2: Cohort B2 (Combination therapy RP2D-B determination, Glioblastoma)

    This cohort evaluates the safety and tolerability of AL3818 12mg (or 10 mg), 4 days on/3 days off (if passed DLT) in combination with Temozolomide (150 mg/m², 5 days on/23 days off) in a 28-day cycle for up to 6 cycles of Temozolomide, or CCNU (90 mg/m²) in a 8-week cycle for up to 6 cycles of CCNU for glioblastoma (GBM) patients. A 3+3 DLT assessment will determine the recommended combination dose (RCD) with RCD-B1 for Temozolomide or RCD-B2 for CCNU respectively. Temozolomide or CCNU is sequentially enrolled at PI's discretion based on patients meeting eligibility criteria. If DLT is observed in this combination therapy, the AL3818 dose will be further reduced to next -2 mg level. Patients from Cohort B1 without DLTs in the first cycle (28 days for Temozolomide or 56 days for CCNU) may transition to this Cohort B2. RCD-B1 and RCD-B2 will be used in phase 2a study.

    Drug: AL3818 · Drug: Temozolomide (TMZ) · Drug: CCNU

  • Experimental
    P2a.3-C: Cohort C (AL3818 monotherapy, Endometrial, LGSOC cancer)

    This cohort evaluates the preliminary efficacy and safety of AL3818 monotherapy at the RP2D (determined from Cohort A, 4 days on/3 days off in 28-day cycles) in patients with advanced endometrial, LGSOC cancer (≥2nd-line, age ≥18) with TP53 mutated adenocarcinoma, TP53 carcinosarcoma and TP53 wild type. Treatment continues until disease progression (PD) or intolerability (n=17 for each TP53 and LGSOC group). LGSOC patient can use AL3818 for1st line treatment at PI's discretion.

    Drug: AL3818

  • Experimental
    P2a.3-D: Cohort D (AL58805 + AL3818, Endometrial, LGSOC and STS)

    This cohort evaluates the safety and efficacy of AL3818 + AL58805 at RP2D (determined from Cohort A2) in patients with advanced endometrial, LGSOC or STS cancer (≥2nd-line, age ≥18). Enrollment n=17 each indication, Optional biomarker research may be included to identify mutations of PIK3CA, PTEN, ARID1A and homologous recombination deficiency. LGSOC patient can use AL3818 for1st line treatment at PI's discretion.

    Drug: AL58805 · Drug: AL3818

  • Experimental
    P2a.3-E: Cohort E (AL3818 + temozolomide or CCNU, Glioblastoma)

    This cohort evaluates the safety and efficacy of AL3818 (RCD-B1 and RCD-B2 from Cohort B1 and B2) qd/4 days on, 3 days off) in combination with Temozolomide (150 mg/m², 5 days on/23 days off) all for 28 days per cycle for up to 6 cycles of Temozolomide, or CCNU (90 mg/m²) in a 8-week cycle for up to 6 cycles of CCNU to PD or intolerability for ≥ 2nd line treatment (age: ≥ 18) GBM patients. Enrollment is at n=17 individually for Temozolomide or CCNU which is sequentially enrolled at PI's discretion.

    Drug: AL3818 · Drug: Temozolomide (TMZ) · Drug: CCNU

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.

  • DrugAL3818

    AL3818 is a novel small molecule dual receptor tyrosine kinase inhibitor, which shows highly selective inhibition of fibroblast growth factor receptor (FGFr) and vascular endothelial growth factor receptor (VEGFR). Preclinical studies of this agent in mouse models, including various cancer xenografts, have demonstrated that treatment of tumor-bearing mice with AL3818 induces tumor reductions.

  • DrugTemozolomide (TMZ)

    Temozolomide is an alkylating agent, which metabolizes to generate active substance methyl triazene imidazole formamide (MTIC), which interferes with the replication and repair of tumor cell DNA and induces apoptosis of cancer cells.

  • DrugCCNU

    CCNU is an alkylating agent that works by damaging cancer cell DNA, ultimately leading to cell death. It is lipid-soluble, allowing it to cross the blood-brain barrier, which is crucial for treating brain tumors.

06

What researchers measure

Primary outcomes

  1. Recommended combination dose (RCD)

    Determine the recommended combination dose (RCD) of AL3818 in combination with other anti-tumor agents based on evaluation of dose-limiting toxicity (DLT) events during Phase 1b.

    Time frame: 36 months

  2. Objective Tumor Response Rate (ORR)

    Evaluate the proportion of participants who achieve Complete Response (CR) or Partial Response (PR) as the best overall tumor response according to RECIST version 1.1; tumor response in participants with GBM is assessed according to RANO 2.0.

    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 AL3818 and, where applicable, AL58805, determined from protocol-specified pharmacokinetic sampling.

    Time frame: 36 months

  2. Pharmacokinetic endpoint: Peak Plasma Concentration (Cmax)

    Evaluate the maximum observed plasma concentration (Cmax) of AL3818 and, where applicable, AL58805 based on plasma concentration-time data collected at protocol-specified pharmacokinetic sampling time points.

    Time frame: 36 months

  3. Pharmacokinetic endpoint: Area Under the Curve (AUC)

    Evaluate the area under the plasma concentration-time curve (AUC) of AL3818 and, where applicable, AL58805 based on plasma concentration-time data collected at protocol-specified pharmacokinetic sampling time points.

    Time frame: 36 months

  4. Duration of Response (DOR)

    Evaluate the time from the date of 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 or RANO 2.0 for GBM.

    Time frame: 36 months

  5. Progression-Free Survival (PFS)

    Evaluate the 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)

    Evaluate the time from Cycle 1 Day 1 (C1D1) to death from any cause.

    Time frame: 36 months

07

Study locations

1 site
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
    • Kirk A. Booker, MPH, CCRP · Contactkabooker@mdanderson.org · (832) 891-5195
    • Carlos Kamiya Matsuoka, MD · Principal investigator
    • Vinay K. Puduvalli, MD · Principal investigator
08

References and documents

Publications

  • Ellingson BM, Wen PY, Cloughesy TF. Modified Criteria for Radiographic Response Assessment in Glioblastoma Clinical Trials. Neurotherapeutics. 2017 Apr;14(2):307-320. doi: 10.1007/s13311-016-0507-6. PubMed 28108885 ↗
  • Glaviano A, Foo ASC, Lam HY, Yap KCH, Jacot W, Jones RH, Eng H, Nair MG, Makvandi P, Geoerger B, Kulke MH, Baird RD, Prabhu JS, Carbone D, Pecoraro C, Teh DBL, Sethi G, Cavalieri V, Lin KH, Javidi-Sharifi NR, Toska E, Davids MS, Brown JR, Diana P, Stebbing J, Fruman DA, Kumar AP. PI3K/AKT/mTOR signaling transduction pathway and targeted therapies in cancer. Mol Cancer. 2023 Aug 18;22(1):138. doi: 10.1186/s12943-023-01827-6. PubMed 37596643 ↗
  • Lai S, Li P, Liu X, Liu G, Xie T, Zhang X, Wang X, Huang J, Tang Y, Liu Z, Shen G, Li C, Lu F, Wang L, Jiang F, Sun C, Chen Y, Chen M. Efficacy and safety of anlotinib combined with the STUPP regimen in patients with newly diagnosed glioblastoma: a multicenter, single-arm, phase II trial. Cancer Biol Med. 2024 Mar 4;21(5):433-44. doi: 10.20892/j.issn.2095-3941.2023.0373. PubMed 38445445 ↗

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
NCT07811297
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.
Carlos K Matsuoka, MD
principal investigator · UT MD Anderson Cancer Center

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.

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Discussion

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Studies of the drug tested here: Anlotinib

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Advenchen Pharmaceuticals, LLC.

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