Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor

A Phase I, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor.

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.

The objective of the trial is to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.

This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.

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