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New treatment option for Cancer
Official title A Phase 1 Study of JMT108 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07317505
What this study is testing
What is JMT108?
JMT108 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Major
- Age ≥18 years
- Participants with histologically or cytologically confirmed locally advanced or metastatic solid tumors who are unresponsive or intolerant to all...
- At least one evaluable tumor lesion according to RECIST v1.1.
- ECOG performance status score ≤2.
You likely can't join if
- 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...
- Nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug;
- 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...
See the full eligibility criteria
- Major
- 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
- 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...
- Nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug;
- 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;
- Use of herbal medicine/products with anti-tumor indications within 2 weeks prior to the first dose of the investigational drug.
The study team makes the final eligibility decision.
Where it's taking place
- Huntersville, North Carolina, United States
- Dallas, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntersville, North Carolina, United States; Dallas, Texas, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.