JMT108 for adults 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

This trial will try JMT108, a bispecific antibody, in adults with locally advanced or metastatic solid tumors who have exhausted standard treatment options to see if it is safe and shows early signs of benefit.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Conjupro Biotherapeutics, Inc. (industry)
• Drugs / interventions: Chemotherapy, immunotherapy
• Locations: 3 sites (Huntersville, North Carolina and 2 other locations)
• Trial ID: NCT07317505 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal participants are adults (≥18) with histologically confirmed locally advanced or metastatic solid tumors, ECOG performance status 0–2, at least one measurable lesion, expected survival ≥3 months, and who are refractory or intolerant to standard therapies.

Not a fit: Patients with active central nervous system metastases, unresolved Grade >1 toxicities from prior therapy, or those who still have effective standard treatment options are unlikely to gain benefit from this study.

Why it matters

Potential benefit: If successful, JMT108 could provide a new treatment option that produces tumor control for some patients with refractory solid tumors.

How similar studies have performed: Bispecific antibodies have shown major success in certain hematologic cancers but remain largely experimental in solid tumors, with only limited early signals of activity in prior trials.

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.

Where this trial is running

Huntersville, North Carolina and 2 other locations

• 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

Conditions: Cancer, cancer, solid tumors, advanced malignant, colorectal cancer, hepatocellular cancer, gastric cancer, melanoma