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Recruiting NCT06589830

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

Phase II Interventional Colorectal Cancer Metastatic Advanced Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TL938 Capsules, Trastuzumab.
Who it may be relevant to
Registry conditions: Colorectal Cancer Metastatic, Advanced Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug TL938 Capsules
    Oral administration
  • Drug Trastuzumab
    Intravenous (IV) infusion

Primary outcome measures

  • Dose limiting toxicity, maximum tolerated dose, and recommended phase 2 dose [Time frame: 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]
Secondary outcome measures (12)
  • Objective Response Rate (ORR) by Investigator [Time frame: Pre-dose up to approximately 24 months post-dose]
  • Duration of Response (DoR) [Time frame: Pre-dose up to approximately 24 months post-dose]
  • Disease Control Rate (DCR) [Time frame: Pre-dose up to approximately 24 months post-dose]
  • Progression Free Survival (PFS) [Time frame: 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]
  • Time to Treatment Failure (TTF) [Time frame: Pre-dose up to approximately 24 months post-dose]
  • Time to Response (TTR) [Time frame: Pre-dose up to approximately 24 months post-dose]
  • Overall Survival (OS) [Time frame: 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]
  • 1-year Survival [Time frame: 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]
  • Number of Participants Experiencing Adverse Drug Reactions (ADR) [Time frame: Pre-dose up to approximately 24 months post-dose]

Eligibility criteria

Inclusion criteria

  • 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;
  • Other inclusion criteria apply for participating in the Study. -

Exclusion criteria

  • 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;
  • Other exclusion criteria apply for participating in the Study. -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Cancer Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT06589830 · TL-HER-202301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗