JMT108 for adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-part, single-agent Phase 1 trial testing the bispecific antibody JMT108 in adults with locally advanced or metastatic solid tumors who have no remaining standard treatment options. Phase 1a uses a BOIN cohort-based dose-escalation design across planned dose levels (0.1, 0.3, 1, and 2 mg/kg) with cohorts of three and a maximum escalation sample size of 30 to identify dose-limiting toxicities and the MTD. Phase 1b will open one or more expansion cohorts at selected dose(s)/frequencies to explore preliminary efficacy, pharmacodynamics, biomarkers, pharmacokinetics, and immunogenicity. Key evaluations include safety/tolerability, PK, anti-drug antibody testing, and tumor response by RECIST v1.1.

Why it matters

Who can join: the full rules

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.

Where it's running

• Carolina BioOncology Institute
  Huntersville, North Carolina, United States Recruiting
• NEXT Dallas
  Dallas, Texas, United States Recruiting
• NEXT Virginia
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: Kevin Romanko
• Email: clinicaltrials.gov@cspcus.com
• Phone: 609-686-6502

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.