ClinicalTrials.gg
Active, not recruitingNCT05731271Updated Sep 29, 2026

A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors

A Phase 1/2 interventional study of TST003 in Locally Advanced Solid Tumor, Metastatic Tumor and Colorectal Adenocarcinoma, sponsored by Transcenta Therapeutics (Hangzhou) Co., Ltd.. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Transcenta Therapeutics (Hangzhou) Co., Ltd. · Phase 1/2, Interventional, and Treatment

Updated Sep 29, 2026Primary completion movedStudy completion moved+1 moreGo to Updates ↓

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Phase
Phase 1/2
Study type
Interventional
Enrollment
111
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 2,053 studies in Neoplasm Metastasis with a site in United States — 345 open to participants now, 541 under way, 58 of them phase 3. Neoplasm Metastasis · United States.

Enrollment
482nd of 1,862
111 · median 43
Started
2023
with 101 others
Phase 1/2
267 of 2,053
63 open now
Primary completion
2027-06
later than 240 of 539 live
Registered
1,748th of 2,053
by date

Among the 2,053 studies in Neoplasm Metastasis with a site in United States, this one is the 482nd largest by enrollment of the 1,862 interventional ones that give a count, is one of 102 that started in 2023, is one of 267 in phase 1/2, reaches primary completion later than 240 of the 539 other live ones, and was the 1,748th registered.

Neoplasm Metastasis

4,045 studies on the registry are indexed under Neoplasm Metastasis; 888 are open to participants now.

Browse Neoplasm Metastasis studies →

Open to participants now

345 of the 2,053 studies in Neoplasm Metastasis with a site in United States are open now. Recruiting first, the newest first:

340 more — sign in →

All 345 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 689 Neoplasm Metastasis studies recruiting now, 536 (78%) set no upper age limit and 97 (14%) stop at 75 or younger; 48 take children under 18; 18 take healthy volunteers.

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

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02

Study summary

The goal of this clinical trial is to test the safety of TST003 in patients with cancer.

The main question[s] it aims to answer are:

  • What is the recommended dose patients can safely receive?
  • How long does this drug remain in the body after administration?
  • What are the side effects of this drug?
  • Does your cancer respond to TST003?
  • Participants on this study will get TST003 intravenously (through a needle into your vein), once every 3 weeks.
  • You may need to come to the study site 2-4 times to have tests to see if you are eligible to be in the study before you begin to receive the study drug.
  • After you start the study drug, you will need to return to the site several times after each dose so the physician can take vital signs, draw blood samples, and evaluate you for safety and wellbeing.
  • Participants will continue taking the drug as long as they are receiving clinical benefit.
  • At the end of your study participation, additional testing is required.
Read the detailed description

Part 1 of the trial will consist cohorts, one dosed every 3 weeks at increasingly higher doses following the Bayesian Optimal Interval (BOIN) design. Part 1 is the dose finding portion of the trial. All locally advanced or metastatic solid tumors are accepted.

18 - 39 patients will be enrolled.

Part 2 consists of 2 pharmacodynamic cohorts of approximately 26-36 patients respectively. For Part 2, participants must have locally advanced or metastatic colorectal cancer (CRC).

The trial will last approximately 3 years, with assessments including but not limited to safety labs, ECGs, ECHO/MUGA, PKs and PDs and CT/MRI tumor assessments, and tumor biopsies based on emerging data found in Part 1.

03

Conditions studied

  • Locally Advanced Solid Tumor
  • Metastatic Tumor
  • Colorectal Adenocarcinoma

Browse trials for

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

  1. At least 18 years of age at the time of .
  2. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
  3. Part 1: Subjects with histological or cytological diagnosed unresectable locally advanced or malignant solid tumors and who can provide . For Part 2: Subjects with histological or cytological diagnosed unresectable locally advanced or metastatic CRC and who can provide archival tumor tissue
  4. Subjects who have tumor progression during or after prior therapy and for whom no standard therapy exists that would confer clinical benefit.
  5. At least 1 per v1.1 ( Part 2 only).
  6. (ECOG) performance status 0 or 1.
  7. of 12 weeks or more.
  8. Calculated ≥30 mL/min per the Cockcroft and Gault formula. 9.Adequate bone marrow function:

    • (ANC) ≥ 1500/mm3 (≥ 1.5 ×103/L);
    • ≥ 100,000/mm3 (≥ 100 × 109/L);
    • ≥ 9.0 g/dL;

10.Adequate blood coagulation function as evidenced by an (INR) ≤ 1.5 and Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 (unless subjects are receiving therapeutic anti-coagulation which affects these parameters, and patients receiving therapeutic anticoagulation should be on a stable dose).

11.Adequate liver function as evidenced by ≤1.5 × ULN and (ALT) and aspartate aminotransferase (AST) ≤3×ULN.

12.Women of (WOCBP) and men who are sexually active with WOCBP must agree to follow instructions for method(s) of during the treatment period and for at least 90 days after the last dose of TST003. Contraception methods should be consistent with local regulations.

Exclusion criteria

Exclusion Criteria:

  1. Untreated or symptomatic central nervous system (CNS) . Note: Subjects with asymptomatic treated are eligible provided they have been clinically stable and not requiring for at least 4 weeks following CNS -directed therapy are eligible for study entry.
  2. Prior systemic anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, or targeted therapy or herbal medicine) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug.
  3. Radical radiation or local-regional therapies (transarterial chemoembolization or radiofrequency ablation) within 4 weeks prior to the first dose of study drug; palliative radiotherapy to a non-target lesion within 2 weeks prior to of study drug.
  4. Any unresolved Grade 2 or greater toxicity from previous anticancer therapy except alopecia.
  5. Any herbal medicine without anti-tumor intent within one week before the first dose of study drug.
  6. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases, including but not limited to pulmonary fibrosis, active pneumonitis.
  7. Severe cardiovascular disease, including cerebrovascular accident, , myocardial infarction, or unstable angina, (NYHA) class III or IV heart failure or uncontrolled arrhythmia within 6 months of the first dose.
  8. Has the average interval by Fridericia's formula (QTcF) prolongation to > 480 millisecond (ms) based on 12-lead in triplicate, or with a history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives).
  9. Uncontrolled hypertension (systolic pressure >150mmHg or diastolic pressure > 90mmHg).
  10. Severe intestinal disease, including but not limited to:

    1. Peptic ulcer disease in the past 3 months prior to the first dosing.
    2. gastrointestinal bleeding as evidenced by hematemesis, hematochezia, or melena in the past 3 months prior to the first dosing without evidence of resolution documented by endoscopy or colonoscopy.
    3. Active colitis requiring ongoing treatment within 4 weeks prior to the first dosing, including infectious colitis, radiation colitis and ischemic colitis.
    4. History of ulcerative colitis or Crohn's disease.
  11. Active or uncontrolled infections requiring IV of antibiotics, antivirals, or antifungals.
  12. Active viral (any etiology) hepatitis except with the viral load below the limit quantification ( virus (HBV) deoxyribonucleic acid (DNA) \< 1000 copies/mL or 200 IU/mL; virus (HCV) ribonucleic acid (RNA) below the limit of quantification).
  13. Known (HIV) infection or known acquired immunodeficiency syndrome.
  14. Females who are pregnant or nursing.
  15. Has known to either the drug substances or inactive ingredients in the drug product.
  16. Prior severe hypersensitivity to other antibodies, which in the opinion of the Investigator suggests an increased potential for hypersensitivity to study drug.
  17. Is currently participating and receiving study therapy or has participated in a study of an agent and received study therapy or used an investigation device within 4 weeks prior to the first dose of study drug.
  18. Has a history or current evidence of any severe condition, concurrent therapy (e.g., psychiatric, substance abuse), or laboratory abnormality that might confound the interpretation of the study results, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the investigator.

    Additional Exclusion Criteria for Part 2 only (for Pharmacodynamic Cohorts)

  19. Prior treatment with a GREM1 targeted therapy.
  20. Any within 3 years prior to the first dosing of study drug except adequately treated localized carcinomas where standard therapy has been administered and patient is considered cured.
  21. Subject will not be able to undergo on-treatment tumor on C3D1 per investigator's best judgement as baseline.
Terms in these criteria, in plain language(30)

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.

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.

Metastases

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

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

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.

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.

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.

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.

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.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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.

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.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
111 participants (actual)

Study arms

  • Experimental
    Phase 1a Part - TST003 Dose Escalation

    TST003 administered every 3 weeks at increasing doses 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg

  • Experimental
    Phase 1b Part - Dose Expansion at Recommended Phase 2 dose

    Administer TST003 every 3 weeks to patients with positive GREM1 tumor expression at the recommended Phase 2 Dose,

Interventions

  • DrugTST003

    IV humanized anti-GREM1 monoclonal antibody

06

What researchers measure

Primary outcomes

  1. Assess the Dose limiting toxicities of TST003

    Assess the Dose limiting toxicities experienced

    Time frame: Observed during the first 21 day cycle

  2. Assess Adverse events (AEs) of TST003

    Assess Adverse events (AEs) as characterized by nature, frequency, and severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

    Time frame: through study completion, an average of 1 year

  3. Assess abnormal findings related to TST003

    Assess the abnormal findings of vital sign, physical examination, laboratory measurements, electrocardiogram (ECG) and echocardiogram (ECHO)/ multigated acquisition scan (MUGA) parameters

    Time frame: through study completion, an average of 1 year

  4. assess the Overall Response Rate of TST003 as monotherapy at the RP2D in subjects with locally advanced or metastatic GREM1 positive solid tumors (Phase 1bPart)

    Overall Response Rate

    Time frame: through study completion, an average of 1 year

  5. assess the Duration of Response of TST003 as monotherapy at the RP2D in subjects with locally advanced or metastatic GREM1 positive solid tumors (Phase 1bPart)

    Duration of Response

    Time frame: through study completion, an average of 1 year

  6. assess the Time to Response of TST003 as monotherapy at the RP2D in subjects with locally advanced or metastatic GREM1 positive solid tumors (Phase 1bPart)

    Time to Response

    Time frame: through study completion, an average of 1 year

  7. assess the Disease Control Rate of TST003 as monotherapy at the RP2D in subjects with locally advanced or metastatic GREM1 positive solid tumors (Phase 1bPart)

    Disease Control Rate

    Time frame: through study completion, an average of 1 year

  8. assess the Progression Free Survival of TST003 as monotherapy at the RP2D in subjects with locally advanced or metastatic GREM1 positive solid tumors (Phase 1bPart)

    Progression Free Survival

    Time frame: through study completion, an average of 1 year

  9. assess the Overall Survival of TST003 as monotherapy at the RP2D in subjects with locally advanced or metastatic GREM1 positive solid tumors (Phase 1bPart)

    Overall Survival Based on investigators' assessment using RECISTv1.1

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. To characterize Area under the Curve (AUC) of TST003

    Determine AUC of serum concentration of TST003 over time

    Time frame: through study completion, an average of 1 year

  2. To characterize Cmax of TST003

    Determine Cmax of serum concentration of TST003

    Time frame: Measured while the patient is on study

  3. To Determine Trough serum concentration of TST003

    Determine Trough serum concentration of TST003

    Time frame: through study completion, an average of 1 year

  4. Determine the formation of Anti-drug antibody (ADA) against TST003

    Determine the formation of Anti-drug antibody (ADA) against TST003

    Time frame: through study completion, an average of 1 year

  5. Determine the formation of Neutralizing antibodies (NAb) against TST003

    Determine the formation of Neutralizing antibodies (NAb) against TST003

    Time frame: through study completion, an average of 1 year

Other outcomes

  1. To assess biomarkers in tumor tissue , and the correlation between biomarkers and PK, pharmacodynamic and clinical outcomes of TST003

    Analyze for biomarkers in tumor tissue samples including but not limited to GREM1, BMPs and FGFR1

    Time frame: through study completion, an average of 1 year

  2. To assess biomarkers, in blood and the correlation between biomarkers and PK, pharmacodynamic and clinical outcomes of TST003

    Analyze for biomarkers in blood samples including but not limited to GREM1 and BMPs

    Time frame: through study completion, an average of 1 year

07

Study locations

3 sites
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar 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

Started Feb 2023 (actual). Primary completion is estimated for Jun 2027, 52 months after the start.

Of 128 industry-sponsored phase 1/2 interventional studies under Neoplasm Metastasis, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 89. This study's planned 52 months is close to that.

Counting every sponsor, half of 214 studies reached it within 62 months; a quarter within 41 and three quarters within 89.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 29, 2026: primary completion Jun 2026 → Jun 2027 and completion Dec 2026 → Sep 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Jan 5, 2023
First posted
Feb 16, 2023
StartActual
Feb 8, 2023
Primary completionEst.
Jun 30, 2027was Jun 2026
CompletionEst.
Sep 30, 2027was Dec 2026
Last update
Sep 29, 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.
Primary completion
Jun 2026→Jun 30, 2027
Sep 29, 2026
Study completion
Dec 2026→Sep 30, 2027
Sep 29, 2026
Sponsor
Suzhou Transcenta Therapeutics Co., Ltd.→Transcenta Therapeutics (Hangzhou) Co., Ltd.
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Primary completion Jun 2026→Jun 30, 2027
    Study completion Dec 2026→Sep 30, 2027
    Sponsor Suzhou Transcenta Therapeutics Co., Ltd.→Transcenta Therapeutics (Hangzhou) Co., Ltd.
    + 3 other changes: identifiers, verification date and arm descriptions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05731271
Lead sponsor
Transcenta Therapeutics (Hangzhou) Co., Ltd.
Responsible party
Sponsor
First posted
Feb 16, 2023
Start date
Feb 8, 2023
Primary completion
Jun 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Sep 29, 2026

Oversight

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

Not currently enrolling

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

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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.

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

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