RightFit
RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests JMT108 in adults with solid tumors that have grown into nearby tissue or spread to other parts of the body. It looks at safety, side effects, the best dose and schedule, and how well the drug works. It also studies how the body handles the drug.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • Tests of tissue or cells show a solid tumor that has grown nearby or spread. Standard treatments have not worked, caused side effects you could not tolerate, or are not available.
  • You have at least one tumor that doctors can check using the study’s rules.
  • You have an ECOG activity score of 0–2: you can care for yourself and are up and about for more than half of your waking hours.
  • You are expected to live at least 3 months.

Who can't join

  • You have active cancer spread to the brain or spinal cord, or cancer spread to their lining.
  • Side effects from past treatment have not returned to mild levels or to your usual level before treatment.
  • You received another unapproved study drug or treatment within 4 weeks before your first JMT108 dose.
  • You received cancer treatment within 4 weeks before your first dose, unless one of the special timing rules below applies.
  • You received nitrosoureas or mitomycin C, types of chemotherapy, within 6 weeks before your first dose.
  • You took oral fluoropyrimidines or small-molecule targeted cancer drugs within 2 weeks or 5 drug half-lives before your first dose, whichever is longer. A half-life is the time it takes the body to clear half of a drug.
  • You used herbal medicines or products meant to treat cancer within 2 weeks before your first dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (3)

NC

TX

VA