The study of Trastuzumab Deruxtecan to assess its efficacy, safety and tolerability in Patients with Selected HER2 Expressing Tumors

Phase 1

Recruiting

• Conditions: HER2 Expressing Tumors; MedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-504721-39-02
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-11
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 413

Inclusion Criteria

Locally advanced, unresectable, or metastatic disease based on most recent imaging, The respective cohorts for patient inclusion are: - Cohort 1: Biliary tract cancer - Cohort 2: Bladder cancer - Cohort 3: Cervical cancer - Cohort 4: Endometrial cancer - Cohort 5: Epithelial ovarian cancer - Cohort 6: Pancreatic cancer - Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer., Progressed following prior treatment or who have no satisfactory alternative treatment option., Prior HER2 targeting therapy is permitted., HER2 expression for eligibility may be based on local or central assessment., Has measurable target disease assessed by the Investigator based on RECIST version 1.1., Has protocol- defined adequate organ function including cardiac, renal and hepatic function.

Exclusion Criteria

History of non-infectious pneumonitis/ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening, Lung-specific intercurrent clinically significant severe illnesses, Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals, Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART, Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression., Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastroesophageal junction, or non-small cell lung cancer, Medical conditions that may interfere with the subject's participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified