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

NCT07317505 | Recruiting Phase 1 FDA Drug

• 1 other identifier: JMT108-002
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 3

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

Conditions

Cancer; Cancer (Solid Tumors)

Keywords

cancer; solid tumors; advanced malignant; colorectal cancer; hepatocellular cancer; gastric cancer; melanoma

Outcome Measures

Primary Outcomes (2)

• Number of participants with Dose Limiting Toxicities as assessed by NCI CTCAE v5.0 (excluding cytokine release syndrome, CRS).

  To evaluate the safety and tolerability of JMT108 to determine the dose and schedule to be used in phase 1b.

  through study completion, an average of 1 year

• Number of participants with Tumor Response as assessed by RECIST version 1.1 criteria

  To evaluate preliminary efficacy of JMT108 injection as monotherapy in participants with advanced malignant tumors.

  through study completion, an average of 1 year

Secondary Outcomes (5)

• JMT108 Pharmacokinetics: Area under the concentration time curve over the dosing interval

  through study completion, an average of 1 year

• JMT108 Pharmacokinetics: Elimination half-life (t1/2)

  through study completion, an average of 1 year

• JMT 108 Pharmacokinetics: Clearance (CL)

  through study completion, an average of 1 year

• JMT108 Objective response rate (ORR)

  through study completion, an average of 1 year

• JMT108 Immunogenicity: Number of participants with anti-drug-antibody (ADA)

  through study completion, an average of 1 year

Other Outcomes (3)

• JMT 108 Pharmacodynamics: Changes in immune cell levels: CD8+ T cells, CD4+ T cells, NK cells, PD-1+ immune cells

  through study completion, an average of 1 year

• JMT 108 Pharmacodynamics: Changes in cytokine levels (including but not limited to): IL-6, IL-8, TNF-α, IFN-γ

  through study completion, an average of 1 year

• JMT108 Correlatives: Correlation of baseline PD-L1 expression with anti-tumor activity

  through study completion, an average of 1 year

Study Arms (3)

Phase 1a Dose Escalation

EXPERIMENTAL

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.

Drug: JMT108

Phase 1a Dose Expansion

EXPERIMENTAL

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.

Drug: JMT108

Phase 1b Cohort Expansion

EXPERIMENTAL

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.

Drug: JMT108

Interventions

JMT108 DRUG

Administered by intravenous injection

Phase 1a Dose Escalation; Phase 1a Dose Expansion; Phase 1b Cohort Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug;
• 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;
• Use of herbal medicine/products with anti-tumor indications within 2 weeks prior to the first dose of the investigational drug.

Sponsors & Collaborators

• Conjupro Biotherapeutics, Inc.: lead

Study Sites (3)

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

RECRUITING

NEXT Dallas

Dallas, Texas, 75039, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Colorectal Neoplasms; Liver Neoplasms; Stomach Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Liver Diseases; Stomach Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Kevin Romanko

CONTACT

609-686-6502; clinicaltrials.gov@cspcus.com

Audrey Li

CONTACT

609-356-0210; clinicaltrials.gov@cspcus.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: January 5, 2026
• Study Start: December 2, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)