Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor

Shanghai JMT-Bio

Status and phase

Unknown

Phase 1

Conditions

Advanced Solid Tumor

Treatments

Drug: JMT101

Study type

Interventional

Funder types

Industry

Identifiers

NCT04689100

JMT101-ECL

Details and patient eligibility

About

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.

Full description

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.

Enrollment

259 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

259 participants in 2 patient groups

Dose Escalation Cohort

Experimental group

Description:

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).

Treatment:

Drug: JMT101

Dose Expansion Cohort

Experimental group

Description:

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

Treatment:

Drug: JMT101