A Master rollover study to provide continued access to, and assess, long term safety of the study drugs.

Phase 1

Recruiting

• Conditions: Advanced (unresectable or metastatic)human epidermal growth receptor 2 (HER2)-expressing/HER2-mutated solid tumors; MedDRA version: 21.0Level: PTClassification code: 10061451Term: Colorectal cancer Class: 100000004864; MedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2; MedDRA version: 20.1Level: PTClassification code: 10055113Term: Breast cancer metastatic Class: 100000004864; MedDRA version: 23.0Level: PTClassification code: 10065430Term: HER2 positive breast cancer Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10059515Term: Non-small cell lung cancer metastatic Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104; MedDRA version: 23.0Level: PTClassification code: 10066896Term: HER2 positive gastric cancer Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10028980Term: Neoplasm Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-506330-73-00
• Lead Sponsor: Daiichi Sankyo Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-27
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition, No evidence of progressive disease and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s)., Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug. Methods considered as highly effective methods of contraception can be found in Protocol Section 10.3.1. If the subject is a female of childbearing potential, she must have a negative urine pregnancy test at Screening, during the Treatment Period, and for 7 months, following the last dose of study drug. A female is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) with surgery at least 1 month before the first dose of study drug or confirmed by follicle stimulating hormone test, Male subjects must not freeze or donate sperm starting at Screening, throughout the study period, and at least 4 months after the final study drug administration., Female subjects must not donate, or retrieve for their own use, ova from the time of Screening and throughout the Treatment Period in the compound-specific sub-protocol (Appendix A) and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time., Sign and date the informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements

Exclusion Criteria

Subjects who permanently discontinued from the study drug in the parent study., Any AE, laboratory abnormality, or intercurrent illness that, in the opinion of the investigator, indicates study participation is not in the best interest of the subject., Local access to commercially available drug at no cost to the subject as permitted by local/country regulation. Note: In countries where, according to local institutional requirements, it is not feasible to switch subjects to the commercial drug through prescription, even if fully reimbursed, subjects will be considered eligible to participate in the Rollover Study., Subjects with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria, Subject who has been off T-DXd therapy for >18 weeks (126 days) between the last dose from the parent study and the initiation of study drug administration on this study

Study & Design

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