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Antibody-Drug Conjugate

Part 1: Dose Escalation Phase (Sub-protocol B) for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Daiichi Sankyo

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 date of enrollment up to date of death due to any cause, up to approximately 5 years

Awards & highlights

Study Summary

This trial will test if it is safe and effective to use valemetostat tosylate along with DXd ADC in patients with advanced solid tumors.

Who is the study for?

Adults with advanced solid tumors who have at least one measurable lesion, can provide a tumor sample, and are in good physical condition (ECOG PS of 0 or 1). Specifically for those with certain types of gastric cancer or non-squamous NSCLC that's progressed after specific treatments.Check my eligibility

What is being tested?

The trial is testing the combination of valemetostat tosylate with two antibody-drug conjugates (DXd ADCs), T-DXd and Dato-DXd, to see if they're safe and effective against advanced solid tumors.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system, infusion-related responses, fatigue, nausea, changes in blood counts leading to increased risk of infections or bleeding. Specific side effect profiles will be monitored closely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date of enrollment up to date of death due to any cause, up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date of enrollment up to date of death due to any cause, up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of enrollment up to date of death due to any cause, up to approximately 5 years 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 Participants Reporting Dose-limiting Toxicities (Part 1 Dose Escalation)

Number of Participants Reporting Treatment-emergent Adverse Events (Part 1 Dose Escalation)

Objective Response Rate Based on Investigator Assessment (Part 2 Dose Expansion)

Secondary outcome measures

Duration of Response (DoR)

Number of Participants Reporting Treatment-emergent Adverse Events (Part 2 Dose Expansion)

Objective Response Rate Based on Investigator Assessment (Part 1 Dose Escalation)

+4 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2: Dose Expansion (Sub-protocol C)Experimental Treatment2 Interventions

Participants with previously treated, locally advanced, unresectable, or metastatic non-squamous non-small cell lung cancer (NSCLC) with or without actionable genomic alteration(s) will receive valemetostat at the RDE in combination with datopotamab deruxtecan (Dato-DXd).

Group II: Part 2: Dose Expansion (Sub-protocol B)Experimental Treatment2 Interventions

Participants with previously treated, advanced, or metastatic HER2-positive gastric or gastro-esophageal junction (GEJ) adenocarcinoma will receive valemetostat at the RDE in combination with T-DXd at RDE.

Group III: Part 1: Dose Escalation Phase (Sub-protocol C)Experimental Treatment2 Interventions

Participants with previously treated, locally advanced, unresectable, or metastatic non-squamous non-small cell lung cancer (NSCLC) with or without actionable genomic alteration(s) will receive valemetostat in combination with datopotamab deruxtecan (Dato-DXd).

Group IV: Part 1: Dose Escalation Phase (Sub-protocol B)Experimental Treatment2 Interventions

Participants with previously treated, advanced, or metastatic HER2-positive gastric or gastro-esophageal junction (GEJ) adenocarcinoma will receive valemetostat in combination with T-DXd.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor

393 Previous Clinical Trials

416,161 Total Patients Enrolled

Daiichi Sankyo, Inc.Lead Sponsor

389 Previous Clinical Trials

420,018 Total Patients Enrolled

Global Clinical LeaderStudy DirectorDaiichi Sankyo

162 Previous Clinical Trials

78,998 Total Patients Enrolled

Frequently Asked Questions

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

Are potential participants currently able to apply for this ongoing medical study?

"As detailed on clinicaltrials.gov, this medical research endeavor is actively seeking candidates. The trial was initially published on February 2nd, 2024 and last revised on April 8th, 2024."

Answered by AI

What are the associated risks of Part 1: Dose Escalation Phase (Sub-protocol B) for individuals?

"The safety assessment for Part 1: Dose Escalation Phase (Sub-protocol B) was rated a 1 by our team at Power on the scale of 1 to 3. This rating reflects the early-stage nature of this Phase 1 trial, indicating minimal available data supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Valemetostat in Combination With DXd ADCs in Subjects With Solid Tumors

2024. "A Study of Valemetostat in Combination With DXd ADCs in Subjects With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06244485.