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Clinical Trials in the USA / NCT06244485
Active, not recruiting Phase 1

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

NCT06244485 · tracked via the Priya Life Science USA tracker
Sponsor
Daiichi Sankyo
Phase
Phase 1
Started
2024-02-22
Last updated
2026-09-15

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

Valemetostat tosylateT-DXdDato-DXd

Valemetostat tosylate: Administered orally once daily

T-DXd: One IV infusion Q3W on Day 1 of each 21-day cycle

Dato-DXd: One IV infusion Q3W on Day 1 of each 21-day cycle.

Study summary

This study will evaluate the safety, tolerability, and efficacy of valemetostat tosylate in combination with DXd antibody-drug conjugates (ADC) in participants with advanced solid tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria All participants must meet all of the following criteria, as well as all criteria from the relevant sub-protocol to be eligible for enrollment: * At least 18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form (ICF) is signed. * Has at least 1 measurable lesion based on investigator imaging assessment (computed tomography or magnetic resonance imaging) using RECIST v 1.1 at Screening. * Is willing to provide an adequate tumor sample. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening. Additional Key Inclusion for Sub-Protocol A: * Diagnosed with pathologically documented breast cancer that: 1. Is unresectable or metastatic. 2. Has progressed on and would no longer benefit from endocrine therapy in hormone receptor-positive subjects in the opinion of the investigator. 3. Has been treated with at least 1 and at most 2 prior lines of chemotherapy in the recurrent or metastatic setting. 4. Has a history of low HER2 expression, defined as immunohistochemistry (IHC) 2+ /in situ hybridization (ISH)-negative or IHC 1+ (ISH-negative or untested), as classified by the American Society of Clinical Oncology/College of American Pathologists 2023 HER2 testing guidelines. 5. Was never previously HER2-positive (IHC 3+ or IHC 2+/ISH+) on prior pathology testing (per American Society of Clinical Oncology/College of American Pathologists guidelines Additional Key Inclusion for Sub-Protocol B: • Gastric or gastro-esophageal junction (GEJ) adenocarcinoma that is (a) unresectable or metastatic (b) has progressed on HER2-directed monoclonal antibody (mAb) containing therapy, such as trastuzumab or approved trastuzumab biosimilar-containing regimen. Additional Key Inclusion for Sub-Protocol C: * Pathologically documented Stage IIIB, IIIC, or IV non-squamous NSCLC with or without actionable genomic alterations (AGA) at the time of enrollment. * Must meet prior therapy requirements: * Participants without AGA: (a) received platinum-based chemotherapy in combination with α-PD-1/α -PD-L1 mAb as the only prior line of therapy or (b) received platinum-based chemotherapy and α -PD-1/ α -PD-L1 mAb (in either order) sequentially as the only 2 prior lines of therapy. * Participants with AGA: (a) has been treated with 1 or 2 prior lines of applicable targeted therapy that is locally approved for participant's genomic alteration at the time of Screening, (b) participants who have received platinum-based chemotherapy as the only prior line of cytotoxic therapy, (c) may have received α -PD-1/α -PD-L1 mAb alone or in combination with a cytotoxic agent Key Exclusion Criteria * Has previously been treated with any enhancer of zeste homolog inhibitors. * Uncontrolled or significant cardiovascular disease. * Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. * Has leptomeningeal carcinomatosis or metastasis. * Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses. * Current use of moderate or strong cytochrome P450 (CYP)3A inducers. * Systemic treatment with corticosteroids (\>10 mg daily prednisone equivalents). * History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs). * Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous (IV) antibiotics, antivirals, or antifungals. * Female who is pregnant or breastfeeding or intends to become pregnant during the study. * Psychological, social, familial, or geographical factors that would prevent regular follow-up. Additional Key Exclusion for Sub-Protocol A: * Has previously received any anti-HER2 therapy in the metastatic setting. * Has received prior treatment with an antibody-drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor, including either as part of prior treatment history or within prior participation in a clinical study. Additional Key Exclusion for Sub-Protocol B: \* Participants who have received an antibody-drug conjugate consisting of an exatecan derivative that is a topoisomerase I inhibitor. Additional Key Exclusion for Sub-Protocol C: \* Has received any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I or TROP2-targeted therapy including Dato-DXD

Primary outcome measure(s)

Trial sites (35)

FacilityCityRegionStatus
City of Hope At Orange County Lennar Foundation Cancer Center Irvine California
Sharp Memorial Hospital San Diego California
Brcr Medical Center, Inc Dba Boca Raton Clinical Research Plantation Florida
University of Hawaii At Manoa Honolulu Hawaii
University of Chicago Medical Center Chicago Illinois
Dana-Farber Cancer Institute Boston Massachusetts
Memorial Sloan-Kettering Cancer Center (Mskcc) - New York New York New York
Clinical Research Alliance Westbury New York
Unc Hospitals Chapel Hill North Carolina
The Cleveland Clinic Foundation Cleveland Ohio
Providence Portland Medical Center Portland Oregon
Mary Crowley Cancer Research Centers Dallas Texas
Ut Southwestern Medical Center Dallas Texas
University of Texas M. D. Anderson Cancer Center Houston Texas
Next Virginia Fairfax Virginia
Fred Hutchinson Cancer Center Seattle Washington
Medical College of Wisconsin Milwaukee Wisconsin
Peking University Third Hospital Beijing China
Sun Yat-Sen University, Cancer Center Guangzhou China
SunYat-Sen University Cancer Center Guangzhou China
Harbin Medical Univeristy Cancer Hospital Heilongjiang China
Hunan Cancer Hospital Hunan China
Jilin Cancer Hospital Jilin City China
Jinana Center Hosptial Shandong China
IRCCS Istituto Scientifico Romagnolo Per Cesena Italy
National Cancer Center Hospital Chūōku Japan
National Hospital Org-Kyushu Cancer Center Fukuoka Japan
National Cancer Center Hospital East Kashiwa Japan
The Cancer Institute Hospital of Jfcr Kōtoku Japan
Aichi Cancer Center Hospital Nagoya Japan
Osaka International Cancer Institute Osaka Japan
Kindai University Hospital Ōsaka-sayama Japan
Shizuoka Cancer Center Shizuoka Japan
Osaka University Hospital Suita Japan
Kanagawa Cancer Center Yokohama Japan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06244485 on ClinicalTrials.gov ↗ ← All trials in the USA