NCT07317505 A Phase 1 Study of JMT108 in Participants With Advanced Solid Tumors
| NCT ID | NCT07317505 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Conjupro Biotherapeutics, Inc. |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2025-12-02 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 270 participants in total. It began in 2025-12-02 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07317505 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07317505 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07317505 currently recruiting?
Yes, NCT07317505 is actively recruiting participants. Contact the research team at clinicaltrials.gov@cspcus.com for enrollment information.
Where is the NCT07317505 trial being conducted?
This trial is being conducted at Huntersville, United States, Dallas, United States, Fairfax, United States.
Who is sponsoring the NCT07317505 clinical trial?
NCT07317505 is sponsored by Conjupro Biotherapeutics, Inc.. The trial plans to enroll 270 participants.
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