A Phase 1 Study of JMT108 in Participants With Advanced Solid Tumors
- Study IRB#:2000041930
- Last Updated:05/29/2026
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
Contact Us
For more information about this study, including how to volunteer, contact:
Ingrid Palma
- Phone Number: 1-203-785-6431
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You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility Criteria
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.
