A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Select… (NCT06271837) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors
China127 participantsStarted 2024-02-22
Plain-language summary
This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan as monotherapy or in combination with anti-cancer agents for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2-expressing solid tumors which are not eligible for curative therapy.
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion Criteria:
* At least 18 years of age.
* 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:
* Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the gastric body or gastroesophageal junction.
* 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 …