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Module A Dose Escalation for Solid Tumors
Phase 1
Recruiting
Led By Shiraj Sen, MD
Research Sponsored by D2M Biotherapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 weeks for the first 24 weeks of treatment and then every 12 weeks until disease progression;up to 24 months
Awards & highlights
Study Summary
"This trial aims to find a safe and effective dose of DM919 for people with solid tumors. It will also determine the best dose of DM919 when used alone or with pembrolizumab.
Who is the study for?
This trial is for individuals with advanced solid tumors. Participants must be able to attend clinic visits, receive intravenous infusions, and undergo blood tests and other assessments.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of a drug called DM919 alone, and in combination with another drug named Pembrolizumab. It aims to find the right dose that's both safe and effective against certain cancers.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with cancer treatments like DM919 or Pembrolizumab may include fatigue, nausea, skin reactions at the infusion site, immune-related issues, or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 weeks for the first 24 weeks of treatment and then every 12 weeks until disease progression;up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks for the first 24 weeks of treatment and then every 12 weeks until disease progression;up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of treatment-emergent events (TEAEs) in Dose Escalation
RDEs or RP2Ds of DM919 alone and in combination with pembrolizumab
Secondary outcome measures
All cohorts
Other outcome measures
Dose Expansion
Trial Design
4Treatment groups
Experimental Treatment
Group I: Module B Combination Therapy Dose EscalationExperimental Treatment2 Interventions
Patients with advanced solid tumors enrolled in dose escalation cohorts treated with DM919 in combination with pembrolizumab
Group II: Module B Combination Therapy Cohort ExpansionExperimental Treatment2 Interventions
Patients with select tumor types enrolled in expansion cohorts treated with DM919 at a dose selected from the Module B Escalation arm, in combination with pembrolizumab
Group III: Module A Dose EscalationExperimental Treatment1 Intervention
Patients with advanced solid tumors enrolled in dose escalation cohorts treated with DM919
Group IV: Module A Cohort ExpansionExperimental Treatment1 Intervention
Patients with select solid tumor types enrolled in expansion cohorts treated with DM919 at a dose selected from the Module A Escalation arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
D2M Biotherapeutics Inc.Lead Sponsor
Shiraj Sen, MDPrincipal InvestigatorNEXT Oncology
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