Clinical trial NCT06589830: TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer
Official title: A Phase 2 Study to Evaluate TL938 Combined With Trastuzumab in Patients With HER2-positive Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Colorectal Cancer Metastatic
Advanced Colorectal Cancer
Keywords: Oncology
TL938
Colorectal Cancer
HER2
Lead sponsor: Suzhou Teligene Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;
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. -

Primary outcomes:
measure: Dose limiting toxicity, maximum tolerated dose, and recommended phase 2 dose
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Objective Response Rate (ORR) by IRC
timeFrame: Pre-dose up to approximately 24 months post-dose
Secondary outcomes:
measure: Objective Response Rate (ORR) by Investigator
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Duration of Response (DoR)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Disease Control Rate (DCR)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Progression Free Survival (PFS)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Time to Tumor Progression (TTP)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Time to Treatment Failure (TTF)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Time to Response (TTR)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Overall Survival (OS)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: 1-year Progression Free Survival
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: 1-year Survival
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Number of Participants Experiencing Adverse Events (AE)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Number of Participants Experiencing Adverse Drug Reactions (ADR)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Number of Participants Experiencing Serious Adverse Events (SAE)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Number of Participants Experiencing Serious Adverse Reactions (SAR)
timeFrame: Pre-dose up to approximately 24 months post-dose
measure: Area Under The Curve (AUC) of TL938
timeFrame: Pre-dose up to 24 hours post-dose
measure: Maximum Plasma Concentration (Cmax) of TL938
timeFrame: Pre-dose up to 24 hours post-dose
measure: Minimum Plasma Concentration (Cmin) of TL938
timeFrame: Pre-dose up to 24 hours post-dose
measure: Time to Peak Drug Concentration (Tmax) of TL938
timeFrame: Pre-dose up to 24 hours post-dose
measure: TL938 half-life (T1/2)
timeFrame: Pre-dose up to 24 hours post-dose
measure: Volume of Distribution (Vz/F) of TL938
timeFrame: Pre-dose up to 24 hours post-dose
measure: Apparent Clearance (CL/f) of TL938
timeFrame: Pre-dose up to 24 hours post-dose
Other outcomes:
Locations:
Study officials:
References: