Actively Recruiting
TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer
Led by Suzhou Teligene Ltd. · Updated on 2026-04-28
80
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase II trial designed to determine the optimal dose and evaluate the effectiveness of TL938 and trastuzumab in treating patients with HER2+ colorectal cancer that has metastasized or recurred and is inoperable.
CONDITIONS
Official 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 anti-VEGF monoclonal antibody
- Patients with dMMR or MSI-H tumors must have received anti-PD-1 monoclonal antibody
- At least one measurable tumor lesion
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
- Minimum life expectancy of more than 3 months
- Adequate bone marrow, liver, kidney, and coagulation function
- Other inclusion criteria required for participation
You will not qualify if you...
- Prior anti-HER2 targeting therapy
- Systemic antitumor 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 clinical trial within 2 weeks or within 5 half-lives from last dose
- Surgery (excluding aspiration biopsy) or major injury within 4 weeks before enrollment
- Unresolved toxicities greater than Grade 1 from prior therapy at screening
- Active central nervous system metastases except asymptomatic CNS metastases without steroid use in last 30 days
- Other primary malignant tumors within 3 years except certain low-risk cancers
- Active uncontrolled infection at screening
- Other exclusion criteria required for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
L
Liling Ding
CONTACT
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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