RecruitingPhase 1NCT07317505

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

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced Malignant Tumors


Sponsor

Conjupro Biotherapeutics, Inc.

Enrollment

270 participants

Start Date

Dec 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study (Phase 1) is testing the safety and appropriate dosage of a new experimental drug called JMT108 in people with advanced solid tumors (cancers) that have stopped responding to standard treatments. **You may be eligible if...** - You are 18 or older - You have a confirmed advanced or metastatic solid tumor that has not responded to standard treatments, or no standard treatment is available - You have at least one measurable or evaluable tumor on imaging - You are in reasonably good physical condition (ECOG score 0–2) - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have active brain or spinal fluid metastases - You have unresolved side effects (grade 2 or higher) from previous cancer treatments - You received chemotherapy, immunotherapy, or other cancer treatments within 4 weeks of starting this study - You are currently taking another unapproved investigational drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJMT108

Administered by intravenous injection


Locations(3)

Carolina BioOncology Institute

Huntersville, North Carolina, United States

NEXT Dallas

Dallas, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07317505


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