TL938 plus trastuzumab for HER2-positive metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, interventional study combines TL938 capsules with trastuzumab to determine an optimal TL938 dose and measure anti-tumor activity and safety in HER2-positive metastatic colorectal cancer. Eligible patients are adults with RAS wild-type, HER2-positive disease that is unresectable or metastatic and previously treated with fluoropyrimidine, oxaliplatin, irinotecan, and an anti-VEGF antibody, with additional requirements for dMMR/MSI-H patients. Patients must have at least one measurable lesion, ECOG performance status 0–2, a life expectancy over three months, and adequate organ function. The trial is conducted at the Cancer Hospital, Chinese Academy of Medical Sciences in Beijing and will track response and tolerability to identify a recommended Phase 2 dose and preliminary efficacy signals.

Why it matters

Who can join: the full rules

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. -

Where it's running

• Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaoyang Xia
• Email: Xiaoyang.xia@teligene.com
• Phone: 8053009373

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.