NCT07317505

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced Malignant Tumors

Recruiting now Phase 1 Last updated 19 January 2026

What this trial tests

Phase 1 trial testing JMT108 in Cancer in 270 participants. Currently enrolling.

Timeline

2 December 2025

Primary endpoint
1 July 2029

1 September 2029

Quick facts

Lead sponsor	Conjupro Biotherapeutics, Inc.
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	270
Start date	2 December 2025
Primary completion	1 July 2029
Estimated completion	1 September 2029
Sites	3 locations across United States

Drugs / interventions tested

• JMT108 — full drug profile →

Conditions studied

• Cancer — all drugs for Cancer →
• Cancer (Solid Tumors) — all drugs for Cancer (Solid Tumors) →

Sponsor

Conjupro Biotherapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Cancer or Cancer (Solid Tumors). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
  To evaluate the safety and tolerability of JMT108 to determine the dose and schedule to be used in phase 1b.
• Number of participants with Tumor Response as assessed by RECIST version 1.1 criteria
  Time frame: through study completion, an average of 1 year
  To evaluate preliminary efficacy of JMT108 injection as monotherapy in participants with advanced malignant tumors.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. After a Decade of Therapy Revolution in Cutaneous Melanoma-Perspectives on Emerging Treatment Strategies.
   Wohlfeil SA, Utikal JS. · · 2026 · PMID 42232604 · DOI 10.32604/or.2026.078650