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

NCT06589830 | Recruiting Phase 2

• 1 other identifier: TL-HER-202301
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Advanced Colorectal Cancer; Colorectal Cancer Metastatic

Keywords

Oncology; TL938; Colorectal Cancer; HER2

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity, maximum tolerated dose, and recommended phase 2 dose

  Pre-dose up to approximately 24 months post-dose

• Objective Response Rate (ORR) by IRC

  Pre-dose up to approximately 24 months post-dose

Secondary Outcomes (21)

• Objective Response Rate (ORR) by Investigator

  Pre-dose up to approximately 24 months post-dose

• Duration of Response (DoR)

  Pre-dose up to approximately 24 months post-dose

• Disease Control Rate (DCR)

  Pre-dose up to approximately 24 months post-dose

• Progression Free Survival (PFS)

  Pre-dose up to approximately 24 months post-dose

• Time to Tumor Progression (TTP)

  Pre-dose up to approximately 24 months post-dose

Study Arms (2)

TL938-Trastuzumab combination

EXPERIMENTAL

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

Drug: TL938 Capsules; Drug: Trastuzumab

TL938

EXPERIMENTAL

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

Drug: TL938 Capsules

Interventions

TL938 Capsules DRUG

Oral administration

TL938; TL938-Trastuzumab combination

Trastuzumab DRUG

Intravenous (IV) infusion

TL938-Trastuzumab combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years old and above, male or female;
• 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;
• At least one measurable lesion;
• Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2;
• A minimum life expectancy of \>3 months;
• Adequate bone marrow reserve, hepatic, renal, and coagulation function;

You may not qualify if:

• Prior anti-HER2 targeting therapy;
• 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;
• Participation in another interventional clinical trial 2 weeks prior to enrollment or within 5haIf-lives from the last dose of IP (whichever is shorter);
• Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment;
• Any unresolved toxicities from prior therapy greater than Grada 1, at the time of screening;
• Active central nervous system (CNS) metastases. Asymptomatic CNS metastases with no steroid use within the last 30 days prior to enrollment is eligible;
• 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;
• Any active infection which has not been controlled at screening;

Sponsors & Collaborators

• Suzhou Teligene Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Colorectal Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Xiaoyang Xia

CONTACT

8053009373; Xiaoyang.xia@teligene.com

Liling Ding

CONTACT

15295298995; liling.ding@medolution.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: May 13, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)