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

Part of paid clinical trials in Huntersville, North Carolina.

Sponsor
Conjupro Biotherapeutics, Inc.
Study ID
NCT07317505
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cancer
  • Cancer (Solid Tumors)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JMT108 — DRUG
    Administered by intravenous injection

Study Details

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

Key Dates

Start date
Dec 2, 2025
Status verified
Jan 2026
Primary completion
Jul 31, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
270 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a Dose Escalation
    In the dose escalation phase, dose escalation will be conducted using a BOIN design. A total of 4 dose levels-0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, and 2 mg/kg-will be sequentially escalated.
  • Experimental: Phase 1a Dose Expansion
    During the dose escalation process, dose expansion and/or exploration of different dosing frequencies (e.g., Q3W) will be conducted for the dose level that the SMC evaluates as safe/ tolerable and where anti-tumor activity is also observed.
  • Experimental: Phase 1b Cohort Expansion
    Participants may be enrolled in the cohort expansion study with tumor types including but not limited to Cohort 1: lung cancer, Cohort 2: colorectal cancer, Cohort 3: hepatic cancer, Cohort 4: gastric cancer, Cohort 5: melanoma and Cohort 6: other malignant tumors (including cervical cancer, renal cancer, bile duct cancer, squamous cell head and neck cell cancer, etc.). Based on the results of Phase 1a, the SMC will discuss and determine the administration dose and frequency for the cohort expansion study. If necessary, several different doses/frequencies may be selected for cohort expansion.

Primary Outcome Measure

Number of participants with Dose Limiting Toxicities as assessed by NCI CTCAE v5.0 (excluding cytokine release syndrome, CRS). [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078
Neel Gandhi, MD
NEXT DallasDallasTexas75039
Shiraj Sen, MD (PRINCIPAL_INVESTIGATOR)
NEXT VirginiaFairfaxVirginia22031
Alex Spira, MD, PhD (PRINCIPAL_INVESTIGATOR)

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Carolina BioOncology Institute· Huntersville, NCNEXT Dallas· Dallas, TXNEXT Virginia· Fairfax, VA

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