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Trial Title:
TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer
NCT ID:
NCT06589830
Condition:
Colorectal Cancer Metastatic
Conditions: Official terms:
Colorectal Neoplasms
Trastuzumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TL938 Capsules
Description:
Oral administration
Arm group label:
TL938
Arm group label:
TL938-Trastuzumab combination
Intervention type:
Drug
Intervention name:
Trastuzumab
Description:
Intravenous (IV) infusion
Arm group label:
TL938-Trastuzumab combination
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.
Criteria for 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. -
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2024
Completion date:
October 2027
Lead sponsor:
Agency:
Suzhou Teligene Ltd.
Agency class:
Industry
Source:
Suzhou Teligene Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06589830
