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โ† Trials
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A Phase 1 Study of JMT108 in Participants With Advanced Solid Tumors

RecruitingPhase 1Ages 18 Years - anyAllConjupro Biotherapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Major Inclusion Criteria: * Age โ‰ฅ18 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 โ‰ค2. * Expected survival โ‰ฅ 3 months Major Exclusion Criteria: * Active central nervous system metastases and/or leptomeningeal metastases * AEs from prior therapy which have not recovered to Grade โ‰ค1 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.
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What it tests

  • JMT108
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Where

3 sites
Carolina BioOncology Institute
Huntersville, United States
NEXT Dallas
Dallas, United States
NEXT Virginia
Fairfax, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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