Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is a Phase I, open label, multi-center study of to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai JMT-Bio Inc.
• Collaborator: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Treatments: Calcium; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• Monotherapy: Pathologically or cytologically confirmed, advanced solid tumor, harboring RAS wild type; Combined with chemotherapy: Pathologically or cytologically confirmed, locally advanced /metastatic colorectal cancer, harboring RAS and BRAF V600E wild type.

• At least 1 measurable lesion according to RECIST 1.1;

• ECOG score 0 or 1;

• Stable for more than 14 days of brain metastasis or spinal cord compression.

Exclusion Criteria:

• Receipt of any EGFR inhibitors within 5 months prior to the first dose of study treatment.

• The second primary malignant tumor was diagnosed within 5 years prior to the first dose of study treatment.

• Known hypersensitivity to any ingredient of JMT101 or their excipients;

• Major surgery within prior 4 weeks of first treatment.

• Receiving an investigational product in another clinical study within 4 weeks;

• History of serious systemic diseases;

• Pregnancy or lactating wo