Actively Recruiting
A Phase 2 Study to Evaluate TL938 Combined With Trastuzumab in Patients With HER2-positive Metastatic Colorectal Cancer
Led by Suzhou Teligene Ltd. · Updated on 2026-04-28
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the optimal dose and effectiveness of TL938 combined with trastuzumab in treating patients with HER2-positive metastatic or recurrent colorectal cancer that cannot be operated on. This Phase II trial focuses on patients whose cancer has metastasized or returned and aims to find the best dosing strategy and assess therapy response. The study is sponsored by Suzhou Teligene Ltd. and involves adults aged 18 and older with specific cancer characteristics including HER2-positive status and prior treatments. Participants will be randomly assigned to one of two treatment groups: one receiving a combination of TL938 capsules taken orally daily plus trastuzumab given intravenously on the first day of each 21-day cycle, and the other receiving TL938 capsules alone daily in 21-day cycles. The study includes a dosing phase and a treatment phase lasting up to approximately 24 months to evaluate safety, dosing limits, and tumor response. Throughout the study, participants will be closely monitored with assessments of tumor response rates, disease control, progression-free survival, and overall survival up to around 24 months after starting treatment. Blood tests will measure TL938 drug levels and safety monitoring will track any side effects or adverse reactions. Patients will undergo regular clinical evaluations and imaging to assess disease status, with safety and treatment effects observed during and after the dosing period.
CONDITIONS
Brief Title
TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years old and above, male or female
- HER2-positive, RAS wild-type, unresectable or metastatic colorectal cancer
- Prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, and an anti-vascular endothelial growth factor monoclonal antibody
- Patients with dMMR or MSI-H tumors must have received anti-PD-1 antibody
- At least one measurable lesion
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
- Minimum life expectancy greater than 3 months
- Adequate bone marrow, liver, kidney, and coagulation function
- Other inclusion criteria apply for participating in the study
You will not qualify if you...
- Prior anti-HER2 targeting therapy
- Systemic anti-tumor therapy (chemotherapy, radiation) within 3 weeks before enrollment
- Immunotherapy within 4 weeks before enrollment
- Palliative radiotherapy for non-target lesions within 2 weeks before enrollment
- Participation in another interventional trial within 2 weeks or within 5 half-lives of last dose
- Surgery of main organs or significant injury within 4 weeks before enrollment
- Unresolved toxicities from prior therapy above Grade 1 at screening
- Active central nervous system metastases (except asymptomatic without recent steroid use)
- Other primary malignant tumors within 3 years except certain low risk cancers
- Active uncontrolled infection at screening
- Other exclusion criteria apply for participating in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 days
Participants begin daily oral TL938 capsules to prepare for combination or monotherapy treatment.
1 baseline visit
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive daily TL938 capsules orally. Those in the combination group also receive Trastuzumab intravenously on Day 1 of each 21-day cycle.
Cycle visits every 21 days
Duration - Up to approximately 24 months post-treatment
Participants are monitored for safety, response, and survival outcomes after treatment ends.
Periodic visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
X
Xiaoyang Xia
L
Liling Ding
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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