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

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

Eligibility

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:

  1. Nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug;
  2. 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;
  3. Use of herbal medicine/products with anti-tumor indications within 2 weeks prior to the first dose of the investigational drug.

Conditions4

Locations3 sites

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