NCT06589830 TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer
| NCT ID | NCT06589830 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Suzhou Teligene Ltd. |
| Condition | Colorectal Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-05-13 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2025-05-13 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 years old and above, male or female; 2. Her2-positive, RAS wild-type, unresectable or metastatic colorectal cancer and prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, and an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb). Patients whose tumors were deficient in mismatch repair (dMMR) proteins or were microsatellite instability-high (MSI-H) must also have received an ant-programmed cell death protain-1 mAb; 3. At least one measurable lesion; 4. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2; 5. A minimum life expectancy of \>3 months; 6. Adequate bone marrow reserve, hepatic, renal, and coagulation function; 7. Other inclusion criteria apply for participating in the Study. - Exclusion Criteria: 1. Prior anti-HER2 targeting therapy; 2. Any systemic ant-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \>30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for nan-target lesions used to relieve symptoms within 2 weeks prior to enrollment; 3. Participation in another interventional clinical trial 2 weeks prior to enrollment or within 5haIf-lives from the last dose of IP (whichever is shorter); 4. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment; 5. Any unresolved toxicities from prior therapy greater than Grada 1, at the time of screening; 6. Active central nervous system (CNS) metastases. Asymptomatic CNS metastases with no steroid use within the last 30 days prior to enrollment is eligible; 7. Any other primary malignant tumors within 3 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix, low risk cancer such as low grade prostate cancer or ductal carcinoma in situ of the breast; 8. Any active infection which has not been controlled at screening; 9. Other exclusion criteria apply for participating in the Study. -
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06589830 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06589830 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06589830 currently recruiting?
Yes, NCT06589830 is actively recruiting participants. Contact the research team at Xiaoyang.xia@teligene.com for enrollment information.
Where is the NCT06589830 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06589830 clinical trial?
NCT06589830 is sponsored by Suzhou Teligene Ltd.. The trial plans to enroll 80 participants.
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