Actively Recruiting
A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors
Led by Daiichi Sankyo · Updated on 2026-02-04
210
Participants Needed
38
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the safety, tolerability, and efficacy of valemetostat tosylate in combination with DXd ADC in patients with advanced solid tumors.
CONDITIONS
Official Title
A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old or the legal adult age at consent
- At least one measurable tumor lesion by imaging using RECIST v1.1 at screening
- Willing to provide an adequate tumor sample
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- For breast cancer: unresectable or metastatic, progressed on endocrine therapy if hormone receptor-positive, treated with 1-2 prior lines of chemotherapy in metastatic setting, low HER2 expression, never previously HER2-positive
- For gastric or gastroesophageal junction adenocarcinoma: unresectable or metastatic, or progressed on trastuzumab or biosimilar regimen
- For non-squamous NSCLC: stage IIIB, IIIC, or IV with or without actionable genomic alterations; prior therapy as specified including platinum-based chemotherapy and PD-1/PD-L1 inhibitors
You will not qualify if you...
- Previous treatment with any enhancer of zeste homolog inhibitors
- Uncontrolled or significant cardiovascular disease
- Spinal cord compression or symptomatic untreated central nervous system metastases
- Leptomeningeal carcinomatosis or metastasis
- Severe lung problems from other illnesses
- Current use of moderate or strong CYP3A inducers
- Systemic corticosteroid treatment exceeding 10 mg prednisone daily
- History of severe allergic reactions to monoclonal antibodies
- Active uncontrolled infections requiring intravenous treatment
- Female who is pregnant, breastfeeding, or planning pregnancy during the study
- Psychological, social, family, or geographic issues preventing regular follow-up
- Breast cancer sub-protocol: prior anti-HER2 therapy in metastatic setting, prior antibody-drug conjugate with exatecan derivative
- Gastric cancer sub-protocol: prior treatment with antibody-drug conjugate containing exatecan derivative
- NSCLC sub-protocol: prior treatment with agents targeting topoisomerase I or TROP2 including Dato-DXd
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 38 locations
1
City of Hope At Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Actively Recruiting
2
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Withdrawn
3
Sharp Memorial Hospital
San Diego, California, United States, 92123
Actively Recruiting
4
Brcr Medical Center, Inc Dba Boca Raton Clinical Research
Plantation, Florida, United States, 33322
Actively Recruiting
5
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, United States, 33612
Withdrawn
6
University of Hawaii At Manoa
Honolulu, Hawaii, United States, 96813
Actively Recruiting
7
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
8
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
Memorial Sloan-Kettering Cancer Center (Mskcc) - New York
New York, New York, United States, 10065
Actively Recruiting
10
Clinical Research Alliance
Westbury, New York, United States, 11590
Actively Recruiting
11
Unc Hospitals
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
12
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Active, Not Recruiting
13
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
14
Mary Crowley Cancer Research Centers
Dallas, Texas, United States, 75230
Actively Recruiting
15
Ut Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
16
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
17
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Withdrawn
18
Next Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
19
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
20
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
21
Peking University Third Hospital
Beijing, China, 100191
Actively Recruiting
22
Sun Yat-Sen University, Cancer Center
Guangzhou, China, 510060
Actively Recruiting
23
SunYat-Sen University Cancer Center
Guangzhou, China, 510060
Actively Recruiting
24
Harbin Medical Univeristy Cancer Hospital
Heilongjiang, China, 150081
Actively Recruiting
25
Hunan Cancer Hospital
Hunan, China, 410013
Actively Recruiting
26
Jilin Cancer Hospital
Jilin, China, 130000
Actively Recruiting
27
Jinana Center Hosptial
Shandong, China, 240013
Actively Recruiting
28
IRCCS Istituto Scientifico Romagnolo Per
Cesena, Italy, 47014
Actively Recruiting
29
National Cancer Center Hospital
Chūōku, Japan, 104-0045
Actively Recruiting
30
National Hospital Org-Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Actively Recruiting
31
National Cancer Center Hospital East
Kashiwa, Japan, 277-8577
Actively Recruiting
32
The Cancer Institute Hospital of Jfcr
Kōtoku, Japan, 135-8550
Actively Recruiting
33
Aichi Cancer Center Hospital
Nagoya, Japan, 464-8681
Actively Recruiting
34
Osaka International Cancer Institute
Osaka, Japan, 540-0008
Actively Recruiting
35
Kindai University Hospital
Ōsaka-sayama, Japan, 589-8511
Actively Recruiting
36
Shizuoka Cancer Center
Shizuoka, Japan, 411-8777
Actively Recruiting
37
Osaka University Hospital
Suita, Japan, 565-0871
Actively Recruiting
38
Kanagawa Cancer Center
Yokohama, Japan, 241-8515
Actively Recruiting
Research Team
D
Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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