TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer

NCT ID: NCT06589830

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2027-10-31

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.

Conditions

Colorectal Cancer Metastatic; Advanced Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TL938-Trastuzumab combination

TL938-Trastuzumab combination receives TL938 capsules by mouth once daily. Trastuzumab given intravenously on Day 1 of each Cycle. Cycle length is 21 days

Group Type: EXPERIMENTAL

TL938 Capsules

Intervention Type: DRUG

Oral administration

Trastuzumab

Intervention Type: DRUG

Intravenous (IV) infusion

TL938

TL938 monotherapy receives TL938 capsules by mouth once daily. Cycle length is 21 days.

Group Type: EXPERIMENTAL

TL938 Capsules

Intervention Type: DRUG

Oral administration

Interventions

TL938 Capsules

Oral administration

Intervention Type: DRUG

Trastuzumab

Intravenous (IV) infusion

Intervention Type: DRUG

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;

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Teligene Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xiaoyang Xia

Role: CONTACT

Xiaoyang.xia@teligene.com

8053009373

Liling Ding

Role: CONTACT

liling.ding@medolution.com

15295298995

Other Identifiers

TL-HER-202301

Identifier Type: -

Identifier Source: org_study_id