Valemetostat + DXd ADCs 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 radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date of enrollment up to date of radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of enrollment up to date of radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Duration of Response (DoR)

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

Progression-free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment 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 2: Dose Expansion (Sub-protocol A)Experimental Treatment2 Interventions

Participants with unresectable or metastatic HER2-low IHC\]1+ or IHC 2+/ISH-negative breast cancer will receive valemetostat at the RDE in combination with T-DXd at RDE.

Group IV: 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 V: 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.

Group VI: Part 1: Dose Escalation (Sub-protocol A)Experimental Treatment2 Interventions

Participants with unresectable or metastatic HER2-low IHC\]1+ or IHC 2+/ISH-negative breast cancer will receive valemetostat in combination with T-DXd.

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