A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors
NCT ID: NCT06244485
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
210 participants
INTERVENTIONAL
2024-02-16
2028-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
Valemetostat tosylate
Administered orally once daily
T-DXd
One IV infusion Q3W on Day 1 of each 21-day cycle
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).
Valemetostat tosylate
Administered orally once daily
Dato-DXd
One IV infusion Q3W on Day 1 of each 21-day cycle.
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.
Valemetostat tosylate
Administered orally once daily
T-DXd
One IV infusion Q3W on Day 1 of each 21-day cycle
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.
Valemetostat tosylate
Administered orally once daily
T-DXd
One IV infusion Q3W on Day 1 of each 21-day cycle
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).
Valemetostat tosylate
Administered orally once daily
Dato-DXd
One IV infusion Q3W on Day 1 of each 21-day cycle.
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.
Valemetostat tosylate
Administered orally once daily
T-DXd
One IV infusion Q3W on Day 1 of each 21-day cycle
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 18 years or the minimum legal adult age (whichever is greater) at the time the 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 IHC 2+ /ISH-negative or IHC 1+ (ISH-negative or untested). ), as classified by the American Society of Clinical Oncology/College of American Pathologists 2018 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 GEJ adenocarcinoma that is (a) unresectable or metastatic or (b) has progressed on 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 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 a prior line of therapy or (b) received platinum-based chemotherapy and α -PD-1/ α -PD-L1 mAb (in either order) sequentially as 2 prior lines of therapy.
* Participants with AGA: (a) has been treated with at least 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 a prior line of cytotoxic therapy, (c) may have received α -PD-1/α -PD-L1 mAb alone or in combination with a cytotoxic agent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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City of Hope At Orange County Lennar Foundation Cancer Center
Irvine, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Brcr Medical Center, Inc Dba Boca Raton Clinical Research
Plantation, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, United States
University of Hawaii At Manoa
Honolulu, Hawaii, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center (Mskcc) - New York
New York, New York, United States
Clinical Research Alliance
Westbury, New York, United States
Unc Hospitals
Chapel Hill, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Mary Crowley Cancer Research Centers
Dallas, Texas, United States
Ut Southwestern Medical Center
Dallas, Texas, United States
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Next Virginia
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
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, , 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
Countries
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Central Contacts
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Other Identifiers
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DS3201-324
Identifier Type: -
Identifier Source: org_study_id
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