A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors (NCT05731271) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors
United States111 participantsStarted 2023-02-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Life expectancy of 12 weeks or more.
✓. Calculated creatinine clearance ≥30 mL/min per the Cockcroft and Gault formula. 9.Adequate bone marrow function:
Exclusion criteria
What they're measuring
1
Assess the Dose limiting toxicities of TST003
Timeframe: Observed during the first 21 day cycle
2
Assess Adverse events (AEs) of TST003
Timeframe: through study completion, an average of 1 year
3
Assess abnormal findings related to TST003
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
✕. 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.
✕. 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).
Timeframe: 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)
Timeframe: 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)
Timeframe: through study completion, an average of 1 year