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

Part of paid clinical trials in Irvine, California.

Sponsor
Daiichi Sankyo
Study ID
NCT06244485
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Valemetostat tosylate — DRUG
    Administered orally once daily
  • T-DXd — DRUG
    One IV infusion Q3W on Day 1 of each 21-day cycle
  • Dato-DXd — DRUG
    One IV infusion Q3W on Day 1 of each 21-day cycle.

Study Details

This study will evaluate the safety, tolerability, and efficacy of valemetostat tosylate in combination with DXd ADC in patients with advanced solid tumors.

Key Dates

Start date
Feb 16, 2024
Status verified
Feb 2026
Primary completion
Nov 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
210 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Escalation Phase (Sub-protocol B)
    Participants with previously treated, advanced, or metastatic HER2-positive gastric or gastro-esophageal junction (GEJ) adenocarcinoma will receive valemetostat in combination with T-DXd.
  • Experimental: Part 1: Dose Escalation Phase (Sub-protocol C)
    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).
  • Experimental: Part 1: Dose Escalation (Sub-protocol A)
    Participants with unresectable or metastatic HER2-low IHC\]1+ or IHC 2+/ISH-negative breast cancer will receive valemetostat in combination with T-DXd.
  • Experimental: Part 2: Dose Expansion (Sub-protocol B)
    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.
  • Experimental: Part 2: Dose Expansion (Sub-protocol C)
    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).
  • Experimental: Part 2: Dose Expansion (Sub-protocol A)
    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.

Primary Outcome Measure

Number of Participants Reporting Dose-limiting Toxicities (Part 1 Dose Escalation) [ Time Frame: Cycle 1 Day 1 up to Day 21 (each cycle is 21 days) ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
City of Hope At Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618-
Valkyrie Clinical TrialsLos AngelesCalifornia90067-
Sharp Memorial HospitalSan DiegoCalifornia92123-
Brcr Medical Center, Inc Dba Boca Raton Clinical ResearchPlantationFlorida33322-
H. Lee Moffitt Cancer Center and Research Institute, IncTampaFlorida33612-
University of Hawaii At ManoaHonoluluHawaii96813-
University of Chicago Medical CenterChicagoIllinois60637-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Memorial Sloan-Kettering Cancer Center (Mskcc) - New YorkNew YorkNew York10065-
Clinical Research AllianceWestburyNew York11590-
Unc HospitalsChapel HillNorth Carolina27514-
The Cleveland Clinic FoundationClevelandOhio44195-
Providence Portland Medical CenterPortlandOregon97213-
Mary Crowley Cancer Research CentersDallasTexas75230-
Ut Southwestern Medical CenterDallasTexas75390-
University of Texas M. D. Anderson Cancer CenterHoustonTexas77030-
Inova Schar Cancer InstituteFairfaxVirginia22031-
Next VirginiaFairfaxVirginia22031-
Fred Hutchinson Cancer CenterSeattleWashington98109-
Medical College of WisconsinMilwaukeeWisconsin53226-

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By research site
City of Hope At Orange County Lennar Foundation Cancer Center· Irvine, CAValkyrie Clinical Trials· Los Angeles, CASharp Memorial Hospital· San Diego, CABrcr Medical Center, Inc Dba Boca Raton Clinical Research· Plantation, FLH. Lee Moffitt Cancer Center and Research Institute, Inc· Tampa, FLUniversity of Hawaii At Manoa· Honolulu, HI

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