Trial | NCT04689100  Report issue

Title

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.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    259
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.
Study Started
Apr 11
2017
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Jun 30
2022
Anticipated
Last Update
Dec 30
2020

Drug JMT101

Monotherapy: Accelerated titration method, IV infusion QW; Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles)

  • Other names: FOLFIRI(Irinotecan, Leucovorin Calcium, and Fluorouracil); mFOLFOX6((Oxaliplatin, Leucovorin Calcium, and Fluorouracil);

Drug JMT101

IV infusion Q2W (28-day cycles)

  • Other names: FOLFIRI; mFOLFOX6; Irinotecan;

Dose Escalation Cohort Experimental

Monotherapy: Six dose levels of JMT101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design. Combined with chemotherapy: Three dose levels of JMT101 will be tested by a conventional 3 + 3 study design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).

Dose Expansion Cohort Experimental

Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.

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
No Results Posted