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

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

Study Overview

• Status: Recruiting
• Conditions: Cancer; Cancer (Solid Tumors)
• Intervention / Treatment: Drug: JMT108

Detailed Description

This Phase 1 study is a single agent, 2-part (including dose escalating and expansion) study conducted in patients with locally advanced or metastatic solid tumors who are unresponsive or intolerant to all standard of care or have no standard of care available.

Dose escalation (Phase 1a) - Dose escalation will be conducted using a BOIN design.

In the dose-escalation phase, 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. The BOIN design is adopted for the dose-escalation part of this study to determine the MTD. The target toxicity rate for the MTD is 0.3, and the maximum sample size for the dose-escalation BOIN design is 30 participants. Participants are enrolled to receive treatment in cohorts of size 3. Dose escalation and de-escalation decisions are made based on the occurrence of DLTs within the DLT observation window.

After thorough evaluation by the SMC, one or more dose levels may be added between the highest escalated dose level and the next lower dose level for better DLT assessment.

The dose escalation phase includes a screening period (D-28 to D-1), a treatment period, an end of treatment (EOT) visit, and a follow-up period.

Cohort expansion (Phase 1b) - Based on the results of Phase 1a, the administration dose and frequency for the cohort expansion phase of study will be determined. If necessary, several different doses/frequencies may be selected for 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: liver cancer, Cohort 4: gastric cancer, Cohort 5: melanoma and Cohort 6: other advanced solid tumors (including cervical cancer, renal cancer, bile duct cancer, head and neck squamous cell head and neck cancer, etc.).

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kevin Romanko; Phone Number: 609-686-6502; Email: clinicaltrials.gov@cspcus.com
• Study Contact Backup: Name: Audrey Li; Phone Number: 609-356-0210; Email: clinicaltrials.gov@cspcus.com

Study Locations

• United States
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Recruiting
      • Carolina BioOncology Institute
      • Contact: Neel Gandhi, MD
  • Texas
    • Dallas, Texas, United States, 75039
      • Recruiting
      • NEXT Dallas
      • Principal Investigator: Shiraj Sen, MD
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • NEXT Virginia
      • Principal Investigator: Alex Spira, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: JMT108; Administered by intravenous injection
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.	Drug: JMT108; Administered by intravenous injection
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.	Drug: JMT108; Administered by intravenous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
JMT108 Pharmacokinetics: Area under the concentration time curve over the dosing interval	JMT 108 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)	JMT108 Pharmacokinetics: Elimination half-life (t1/2)	through study completion, an average of 1 year
JMT 108 Pharmacokinetics: Clearance (CL)	JMT108 Pharmacokinetics: Clearance (CL)	through study completion, an average of 1 year
JMT108 Objective response rate (ORR)	ORR is defined as the proportion of patients in whom a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 is observed as best overall response	through study completion, an average of 1 year
JMT108 Immunogenicity: Number of participants with anti-drug-antibody (ADA)	JMT108 Immunogenicity: Number of participants with anti-drug-antibody (ADA)	through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
JMT 108 Pharmacodynamics: Changes in immune cell levels: CD8+ T cells, CD4+ T cells, NK cells, PD-1+ immune cells	JMT 108 Pharmacodynamics: Changes in immune cell levels: CD8+ T cells, CD4+ T cells, NK cells, PD-1+ immune cells to explore the PD characteristics of JMT108 Injection	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	Changes in cytokine levels (including but not limited to): IL-6, IL-8, TNF-α, IFN-γ to explore the PD characteristics of JMT108 Injection	through study completion, an average of 1 year
JMT108 Correlatives: Correlation of baseline PD-L1 expression with anti-tumor activity	Correlation of baseline PD-L1 expression with anti-tumor activity to explore the correlation between biomarker levels and preliminary efficacy	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Conjupro Biotherapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: colorectal cancer; cancer; gastric cancer; solid tumors; melanoma; hepatocellular cancer; advanced malignant
• Additional Relevant MeSH Terms: Neoplasms by Site; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Rectal Diseases; Liver Diseases; Colonic Diseases; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Neoplasms; Stomach Neoplasms; Colorectal Neoplasms; Liver Neoplasms; Melanoma
• Other Study ID Numbers: JMT108-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No