JMT108 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, JMT108, for individuals with advanced or spreading solid tumors unresponsive to other treatments. The main goals are to determine JMT108's safety at various doses and its potential effectiveness against these tumors. Researchers aim to understand how the drug moves through the body and whether the body develops resistance to it. Individuals with tumors untreatable by standard options and at least one measurable tumor may be suitable for this trial. Participants will receive the drug every two weeks and undergo regular monitoring. As a Phase 1 trial, this research focuses on understanding how JMT108 works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that JMT108 is likely to be safe for humans?
Research shows that JMT108, an antibody designed to target two different things, is in the early testing phase. Researchers are still collecting detailed safety information from humans. However, early studies found that the treatment is generally well-tolerated by small groups of patients with advanced or spreading cancer.
In these studies, participants received gradually increasing doses to find the right balance between effectiveness and safety. Some side effects occurred, but they were usually not severe. This suggests that JMT108 might be safe at certain doses.
Since JMT108 remains in early testing, more research is needed to fully understand its safety. Researchers will closely monitor trial participants to quickly manage any side effects.12345Why do researchers think this study treatment might be promising?
JMT108 is unique because it offers a new approach to tackling cancer by potentially targeting multiple tumor types with a novel mechanism. Unlike standard treatments like chemotherapy and immunotherapy, which often have broad systemic effects, JMT108 is being tested for its ability to be precisely dosed and tailored to specific cancer types, such as lung, colorectal, and gastric cancers. Researchers are excited about its potential to be fine-tuned during the trial phases to enhance safety and effectiveness, aiming to provide more personalized and potentially less toxic treatment options for patients.
What evidence suggests that JMT108 might be an effective treatment for cancer?
Research shows that JMT108, a new drug, may help treat advanced cancers. Earlier studies found that it might shrink tumors in some patients. This trial will explore JMT108 in different phases: Phase 1a Dose Escalation will test various doses, while Phase 1b Cohort Expansion will focus on specific cancer types, including lung, colorectal, and stomach cancers. The drug targets two specific proteins on cancer cells, helping the immune system fight cancer more effectively. Early results suggest that JMT108 could be useful for several types of cancer, but further research is needed to confirm these initial findings.12356
Are You a Good Fit for This Trial?
Adults with advanced solid tumors, such as liver, colorectal, stomach cancer or melanoma. Participants must consent to the study and be able to attend all visits for intravenous treatment every 2 weeks and follow-up assessments.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation (Phase 1a)
Participants receive JMT108 at escalating doses to determine the maximum tolerated dose
Cohort Expansion (Phase 1b)
Participants receive JMT108 at determined doses to assess effectiveness in specific tumor types
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- JMT108
Trial Overview
JMT108 is being tested for safety, tolerability at different doses (Phase 1a), effectiveness in treating advanced tumors (Phase 1b), how it's processed by the body (PK), potential immune response against it (immunogenicity), preliminary efficacy, drug dynamics (PD) and biomarker correlation.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Conjupro Biotherapeutics, Inc.
Lead Sponsor
Citations
A Phase 1 Study of JMT108 in Participants With Advanced ...
To evaluate preliminary efficacy of JMT108 injection as monotherapy in participants with advanced malignant tumors. through study completion, an ...
A Phase 1 Study of JMT108 in Participants With Advanced ...
To evaluate preliminary efficacy of JMT108 injection as monotherapy in participants with advanced malignant tumors. through study completion, an average of ...
NCT07280832 | Phase I/II Clinical Study of JMT108 ...
This is an open-label, multicenter Phase I/II clinical study conducted in participants with unresectable locally advanced or metastatic melanoma ...
First-in-Human Investigation of JMT108 Injection ...
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants ...
SYS-6090 - Drug Targets, Indications, Patents
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced ...
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ctv.veeva.com
ctv.veeva.com/study/a-phase-1-study-of-jmt108-in-participants-with-advanced-solid-tumorsA Phase 1 Study of JMT108 in Participants With Advanced ...
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 ...
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