Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cancer (Solid Tumors) | Malignant Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JMT108 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase 1a Dose Escalation
- description
- 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.
- interventionNames
- Drug: JMT108
- type
- EXPERIMENTAL
- label
- Phase 1a Dose Expansion
- description
- 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.
- interventionNames
- Drug: JMT108
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available