Recruiting

Phase 1

JMT108A Phase 1 Study of JMT108 in Participants With Advanced Solid Tumors

Sponsor:

Conjupro Biotherapeutics, Inc.

Code:

NCT07317505

Conditions

Cancer

Cancer (Solid Tumors)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JMT108

Study Details

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)

Study ID

NCT07317505

Start date

Dec 2, 2025

Status verified date

Jan, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

270 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

JMT108

Administered by intravenous injection

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 ]
Number of participants with Tumor Response as assessed by RECIST version 1.1 criteria [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Kevin Romanko

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

Audrey Li

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

Locations

Carolina BioOncology Institute

Recruiting

Huntersville, North Carolina, United States, 28078

NEXT Dallas

Recruiting

Dallas, Texas, United States, 75039

Principal Investigator:

Shiraj Sen, MD

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator:

Alex Spira, MD, PhD

More Information

Sponsor

Conjupro Biotherapeutics, Inc.

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Conjupro Biotherapeutics, Inc. on 2026-01-21.