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

ConditionsColorectal Cancer Metastatic Advanced Colorectal Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorSuzhou Teligene Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: TL938-Trastuzumab combinationExperimental treatment 2 interventions

Group B: TL938Experimental treatment 1 intervention