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

April 22, 2026 updated by: Suzhou Teligene Ltd.

A Phase 2 Study to Evaluate TL938 Combined With Trastuzumab in Patients With HER2-positive Metastatic Colorectal Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Drug: TL938 Capsules
Oral administration
Drug: Trastuzumab
Intravenous (IV) infusion
Experimental: TL938
TL938 monotherapy receives TL938 capsules by mouth once daily. Cycle length is 21 days.
Drug: TL938 Capsules
Oral administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Dose limiting toxicity, maximum tolerated dose, and recommended phase 2 dose
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose
Objective Response Rate (ORR) by IRC
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Duration of Response (DoR)
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose
Disease Control Rate (DCR)
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose
Progression Free Survival (PFS)
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose
Time to Tumor Progression (TTP)
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose
Time to Response (TTR)
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose
Time to Treatment Failure (TTF)
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose
Overall Survival (OS)
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose
1-year Progression Free Survival
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose
1-year Survival
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Adverse Events (AE)
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Adverse Drug Reactions (ADR)
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Events (SAE)
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose
Number of Participants Experiencing Serious Adverse Reactions (SAR)
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose
Objective Response Rate (ORR) by Investigator
Time Frame: Pre-dose up to approximately 24 months post-dose
Pre-dose up to approximately 24 months post-dose
Area Under The Curve (AUC) of TL938
Time Frame: Pre-dose up to 24 hours post-dose
Pre-dose up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of TL938
Time Frame: Pre-dose up to 24 hours post-dose
Pre-dose up to 24 hours post-dose
Minimum Plasma Concentration (Cmin) of TL938
Time Frame: Pre-dose up to 24 hours post-dose
Pre-dose up to 24 hours post-dose
Time to Peak Drug Concentration (Tmax) of TL938
Time Frame: Pre-dose up to 24 hours post-dose
Pre-dose up to 24 hours post-dose
TL938 half-life (T1/2)
Time Frame: Pre-dose up to 24 hours post-dose
Pre-dose up to 24 hours post-dose
Volume of Distribution (Vz/F) of TL938
Time Frame: Pre-dose up to 24 hours post-dose
Pre-dose up to 24 hours post-dose
Apparent Clearance (CL/f) of TL938
Time Frame: Pre-dose up to 24 hours post-dose
Pre-dose up to 24 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suzhou Teligene Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TL-HER-202301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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