A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors
NCT ID: NCT06271837
Last Updated: 2025-10-22
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
PHASE2
175 participants
INTERVENTIONAL
2024-02-18
2027-04-01
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
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1
HER2 IHC 3+ solid tumors (excluding breast and gastric cancer)
Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Part 2 Cohort A
HER2 IHC 2+ solid tumors (excluding breast and gastric cancer)
Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Part 2 Cohort B
HER2 IHC 1+ gynecologic cancers
Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Part 3
HER2 IHC 3+ or 2+ cervical cancer
Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Bevacizumab
Bevacizumab by intravenous infusion
Interventions
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Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Bevacizumab
Bevacizumab by intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Locally advanced, unresectable, or metastatic solid tumors based on most recent imaging.
* HER2 expression.
* ECOG performance status of 0-1.
* Must provide an adequate FFPE tumor sample to centrally determine HER2 status and other correlatives.
* Has measurable target disease assessed by the investigator based on RECIST 1.1.
* Adequate organ function and bone marrow within 14 days before enrollment.
* Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Capable of giving signed informed consent.
* Provision of signed and dated written ICF prior to mandatory study-specific procedures, sampling, or analyses.
* Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.
Exclusion Criteria
* Has substance abuse or any other medical conditions that may interfere with the patient's participation in the clinical study or evaluation of the clinical study results.
* A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and concentrated ascites reinfusion therapy.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated.
* Has unresolved toxicities from previous anti cancer therapy.
* Has any spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.
* Uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals, or active infection including tuberculosis.
* Active primary immunodeficiency, known uncontrolled active HIV infection, or active Hepatitis B or C infection.
* Protocol-defined inadequate cardiac function.
* History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
* Has a concomitant medical condition that would increase the risk of toxicity in the opinion of the investigator.
* Anti cancer chemotherapy without an adequate treatment washout period prior to enrollment.
* Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.
* Known allergy or hypersensitivity to study treatment or any excipients of the product or other mAbs.
* Involvement in the planning and/or conduct of the study.
* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
* Previous enrollment in the present study. Concurrent enrollment in another therapeutic clinical study (excluding observational studies).
* For females only: Currently pregnant or breast feeding, or who are planning to become pregnant.
18 Years
130 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Changchun, , China
Research Site
Changsha, , China
Research Site
Changzhou, , China
Research Site
Chengdu, , China
Research Site
Chongqing, , China
Research Site
Dongyang, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Haikou, , China
Research Site
Hangzhou, , China
Research Site
Hangzhou, , China
Research Site
Hangzhou, , China
Research Site
Harbin, , China
Research Site
Hefei, , China
Research Site
Kunming, , China
Research Site
Lishui, , China
Research Site
Nanchang, , China
Research Site
Shandong, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shenyang, , China
Research Site
Taiyuan, , China
Research Site
Wuhan, , China
Research Site
Xi'an, , China
Research Site
Xuzhou, , China
Research Site
Yinchuan, , China
Research Site
Zhengzhou, , China
Research Site
Zhengzhou, , China
Countries
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Central Contacts
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Other Identifiers
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D781AC00001
Identifier Type: -
Identifier Source: org_study_id
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