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Module B Combination Therapy Cohort Expansion 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks for the first 24 weeks of treatment and then every 12 weeks until disease progression;up to 24 months for reporting.

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

D2M Biotherapeutics Inc.Lead Sponsor

Shiraj Sen, MDPrincipal InvestigatorNEXT Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this research study currently ongoing?

"As per the details on clinicaltrials.gov, it is observed that this particular trial is not presently open for recruitment. The initial posting of the trial was recorded on March 1st 2024 and its latest update occurred on March 18th 2024. Despite this study being closed for enrollment, there exist a total of 2742 other ongoing trials welcoming new participants at present."

Answered by AI

Has the FDA given its approval for Module A Cohort Expansion?

"Rated at 1 on our safety assessment scale, Module A Cohort Expansion shows early-stage promise as a Phase 1 trial with modest evidence backing its safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors

2024. "A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06328673.

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