A Phase 1 Study of JMT108 in Participants With Advanced Solid Tumors

About

Brief Summary

The goal of this clinical trial is to test JMT108, a type of drug called a bispecific antibody in adult patients with locally advanced or metastatic solid tumors.

The main questions it aims to answer are:

To assess the safety and tolerability of JMT108 at increasing doses and determine the dose and schedule to be used in the second part of the study (Phase 1a)
To assess effectiveness of JMT108 in participants with locally advanced or metastatic tumors (Phase 1b)
To evaluate how quickly JMT108 is metabolized by the body (pharmacokinetics or PK)
To evaluate if antibodies to the study drug develop (immunogenicity)
To evaluate preliminary efficacy to the drug
To explore the pharmacodynamic (PD) characteristics of JMT108
To explore the correlation between biomarker levels and preliminary efficacy

Participants will:

Provide written informed consent
Undergo screening tests to ensure they are eligible for study treatment
Attend all required study visits and receive JMT108 by intravenous injection every 2 weeks until the study doctor determines study treatment should be stopped, based on how well a participant is doing on treatment
Be followed for progression every 3 months for up to 2 years

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Major Inclusion Criteria:

Age ≥18 years
Participants with histologically or cytologically confirmed locally advanced or metastatic solid tumors who are unresponsive or intolerant to all standard of care or have no standard of care available
At least one evaluable tumor lesion according to RECIST v1.1.
ECOG performance status score ≤2.
Expected survival ≥ 3 months

Major Exclusion Criteria:

Active central nervous system metastases and/or leptomeningeal metastases
AEs from prior therapy which have not recovered to Grade ≤1 or baseline as per NCI CTCAE v5.0 Prior therapy
Any other unapproved investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug (C1D1).
Chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor therapies within 4 weeks prior to the first dose of the investigational drug, except in the following situations:
- Nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug;
- Use of oral fluoropyrimidines and small-molecule targeted drugs within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of the investigational drug;
- Use of herbal medicine/products with anti-tumor indications within 2 weeks prior to the first dose of the investigational drug.