A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and tolerability of DS-1055a in participants with relapsed or refractory locally advanced or metastatic solid tumors for which no standard treatment is available.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Criteria

Inclusion Criteria:

• Has a histopathologically documented locally advanced or metastatic head and neck, gastric, or esophageal cancer, or the other types of solid tumors.

• Has a relapsed or refractory disease that is not amenable to curative standard therapy.

• Is 18 years of age or older (or complies with country-specific regulatory requirements, at least 20 years of age in Japan).

• Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1, with no deterioration for two weeks.

• Has a measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

• Has adequate organ function within 7 days before enrollment.

• Is able to provide written informed consent and is willing and able to comply with the protocol.

Exclusion Criteria:

• Has a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Participants with history of the second malignancy have been disease-free for <3 years.

• Has a history of (non-infectious) interstitial lung disease (ILD) that required steroids, currently has ILD, or when suspected ILD cannot be ruled out by imaging at screening.

• Has a history of severe pulmonary compromise or requirement of supplemental oxygen within 6 months before enrollment.

• Has active hepatitis B or hepatitis C virus infection.

• Has received prior immunotherapy with a Grade 3 or higher, or any unresolved ≥Grade 2 immune-related adverse event.