Locally Advanced Solid TumorPhase 1/2NCT05731271
A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors
A Phase 1/2 study testing TST003 in people with Locally Advanced Solid Tumor and Metastatic Tumor, run by Transcenta Therapeutics (Hangzhou) Co., Ltd. at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Solid Tumor, Metastatic Tumor, Colorectal Adenocarcinoma
- What is being tested?
- TST003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Feb 2023to 30 Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age at the time of informed consent.
- Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
- Part 1: Subjects with histological or cytological diagnosed unresectable locally advanced or metastatic malignant solid tumors and who can provide archival tumor tissue. For Part 2: Subjects with histological or cytological diagnosed unresectable locally advanced or metastatic CRC and who can provide archival tumor tissue
- Subjects who have tumor progression during or after prior therapy and for whom no standard therapy exists that would confer clinical benefit.
- At least 1 measurable lesion per RECIST v1.1 ( Part 2 only).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
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- Life expectancy of 12 weeks or more.
- Calculated creatinine clearance ≥30 mL/min per the Cockcroft and Gault formula. 9.Adequate bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 ×103/L);
- Platelets ≥ 100,000/mm3 (≥ 100 × 109/L);
- Hemoglobin ≥ 9.0 g/dL;
- 10.Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) ≤ 1.5 and Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 ULN (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 bilirubin ≤1.5 × ULN and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN.
- 12.Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception during the treatment period and for at least 90 days after the last dose of TST003. Contraception methods should be consistent with local regulations.
Who cannot join
- Untreated or symptomatic central nervous system (CNS) metastases. Note: Subjects with asymptomatic treated CNS metastases are eligible provided they have been clinically stable and not requiring steroid for at least 4 weeks following CNS -directed therapy are eligible for study entry.
- 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.
- 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.
- Any unresolved Grade 2 or greater toxicity from previous anticancer therapy except alopecia.
- Any herbal medicine without anti-tumor intent within one week before the first dose of study drug.
- History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases, including but not limited to pulmonary fibrosis, active pneumonitis.
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- Severe cardiovascular disease, including cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina, New York Heart Association (NYHA) class III or IV heart failure or uncontrolled arrhythmia within 6 months of the first dose.
- Has the average corrected QT interval by Fridericia's formula (QTcF) prolongation to > 480 millisecond (ms) based on 12-lead ECG 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).
- Uncontrolled hypertension (systolic pressure >150mmHg or diastolic pressure > 90mmHg).
- Severe intestinal disease, including but not limited to:
- Peptic ulcer disease in the past 3 months prior to the first dosing.
- Clinically significant 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.
- Active colitis requiring ongoing treatment within 4 weeks prior to the first dosing, including infectious colitis, radiation colitis and ischemic colitis.
- History of ulcerative colitis or Crohn's disease.
- Active or uncontrolled infections requiring IV of antibiotics, antivirals, or antifungals.
- Active viral (any etiology) hepatitis except with the viral load below the limit quantification (hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < 1000 copies/mL or 200 IU/mL; hepatitis C virus (HCV) ribonucleic acid (RNA) below the limit of quantification).
- Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome.
- Females who are pregnant or nursing.
- Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
- Prior severe hypersensitivity to other antibodies, which in the opinion of the Investigator suggests an increased potential for hypersensitivity to study drug.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks prior to the first dose of study drug.
- 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)
- Prior treatment with a GREM1 targeted therapy.
- Any malignancy 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.
- Subject will not be able to undergo on-treatment tumor biopsy on C3D1 per investigator's best judgement as baseline.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mary Crowley
Dallas, Texas, 75231
OHSU
Portland, Oregon, 97239
NEXT Oncology
San Antonio, Texas, 78229
About this study
Official title: A First-in-Human, Open-Label, Multi-Center Phase 1 Study of TST003 in Subjects With Locally Advanced or Metastatic Solid Tumors
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.
- Being tested
- TST003
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TST003Drug
IV humanized anti-GREM1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Part - TST003 Dose Escalation | Experimental | TST003 administered every 3 weeks at increasing doses 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg |
| Phase 1b Part - Dose Expansion at Recommended Phase 2 dose | Experimental | Administer TST003 every 3 weeks to patients with positive GREM1 tumor expression at the recommended Phase 2 Dose, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Dose limiting toxicities of TST003
Assess the Dose limiting toxicities experienced
Measured: Observed during the first 21 day cycle
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
Measured: through study completion, an average of 1 year
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
Measured: through study completion, an average of 1 year
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
Measured: through study completion, an average of 1 year
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
Measured: through study completion, an average of 1 year
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
Measured: through study completion, an average of 1 year
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
Measured: through study completion, an average of 1 year
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
Measured: through study completion, an average of 1 year
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
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
To characterize Area under the Curve (AUC) of TST003
Determine AUC of serum concentration of TST003 over time
Measured: through study completion, an average of 1 year
To characterize Cmax of TST003
Determine Cmax of serum concentration of TST003
Measured: Measured while the patient is on study
To Determine Trough serum concentration of TST003
Determine Trough serum concentration of TST003
Measured: through study completion, an average of 1 year
Determine the formation of Anti-drug antibody (ADA) against TST003
Determine the formation of Anti-drug antibody (ADA) against TST003
Measured: through study completion, an average of 1 year
Determine the formation of Neutralizing antibodies (NAb) against TST003
Determine the formation of Neutralizing antibodies (NAb) against TST003
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start8 Feb 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Interventional Model: Sequential Assignment Interventional Model Description: Bayesian Optimal Interval (BOIN) design followed by evaluation for efficacy and safety of TST003 as monotherapy at the recommended dose for dose expansion phase or RP2D in subjects with locally advanced or metastatic colorectal cancer (CRCMasking: None (Open Label)
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transcenta Therapeutics (Hangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731271
- Sponsor's protocol ID
- TST003-1001
- Status last verified
- Sep 2026
- First submitted
- 5 Jan 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Open-Label, Multi-Center Phase 1 Study of TST003 in Subjects With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05731271
- Acronym / sponsor ID
- TST003-1001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Transcenta Therapeutics (Hangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional Model: Sequential Assignment Interventional Model Description: Bayesian Optimal Interval (BOIN) design followed by evaluation for efficacy and safety of TST003 as monotherapy at the recommended dose for dose expansion phase or RP2D in subjects with locally advanced or metastatic colorectal cancer (CRCMasking: None (Open Label)
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Part - TST003 Dose Escalation | Experimental | –TST003 administered every 3 weeks at increasing doses 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg |
| Phase 1b Part - Dose Expansion at Recommended Phase 2 dose | Experimental | –Administer TST003 every 3 weeks to patients with positive GREM1 tumor expression at the recommended Phase 2 Dose, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- At least 18 years of age at the time of informed consent.
- Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
- Part 1: Subjects with histological or cytological diagnosed unresectable locally advanced or metastatic malignant solid tumors and who can provide archival tumor tissue. For Part 2: Subjects with histological or cytological diagnosed unresectable locally advanced or metastatic CRC and who can provide archival tumor tissue
- Subjects who have tumor progression during or after prior therapy and for whom no standard therapy exists that would confer clinical benefit.
- At least 1 measurable lesion per RECIST v1.1 ( Part 2 only).
Key exclusion criteria (26 listed)
- Untreated or symptomatic central nervous system (CNS) metastases. Note: Subjects with asymptomatic treated CNS metastases are eligible provided they have been clinically stable and not requiring steroid for at least 4 weeks following CNS -directed therapy are eligible for study entry.
- 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.
- 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.
- Any unresolved Grade 2 or greater toxicity from previous anticancer therapy except alopecia.
- Any herbal medicine without anti-tumor intent within one week before the first dose of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TST003IV humanized anti-GREM1 monoclonal antibody | Drug | – |
Primary outcome
Assess the Dose limiting toxicities of TST003
Time frame: Observed during the first 21 day cycle
Assess the Dose limiting toxicities experienced
Assess Adverse events (AEs) of TST003
Time frame: through study completion, an average of 1 year
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
Assess abnormal findings related to TST003
Time frame: through study completion, an average of 1 year
Assess the abnormal findings of vital sign, physical examination, laboratory measurements, electrocardiogram (ECG) and echocardiogram (ECHO)/ multigated acquisition scan (MUGA) parameters
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)
Time frame: through study completion, an average of 1 year
Overall Response Rate
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)
Time frame: through study completion, an average of 1 year
Duration of Response
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 frame: through study completion, an average of 1 year
Time to Response
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)
Time frame: through study completion, an average of 1 year
Disease Control Rate
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)
Time frame: through study completion, an average of 1 year
Progression Free Survival
assess the Overall Survival of TST003 as monotherapy at the RP2D in subjects with locally advanced or metastatic GREM1 positive solid tumors (Phase 1bPart)
Time frame: through study completion, an average of 1 year
Overall Survival Based on investigators' assessment using RECISTv1.1
5 secondary outcomes
To characterize Area under the Curve (AUC) of TST003
Time frame: through study completion, an average of 1 year
To characterize Cmax of TST003
Time frame: Measured while the patient is on study
To Determine Trough serum concentration of TST003
Time frame: through study completion, an average of 1 year
Determine the formation of Anti-drug antibody (ADA) against TST003
Time frame: through study completion, an average of 1 year
Determine the formation of Neutralizing antibodies (NAb) against TST003
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TST003 in people with Locally Advanced Solid Tumor and Metastatic Tumor, run by Transcenta Therapeutics (Hangzhou) Co., Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the Dose limiting toxicities of TST003 (time frame: Observed during the first 21 day cycle). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.