Overview
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.
Description
This Phase 1, open-label, non-randomized, dose escalation, first-in-human study will assess the safety and tolerability of DS-1055a, determine the maximum tolerated dose of DS-1055a, pharmacokinetic (PK) properties of DS-1055a, and the incidence of anti-drug antibodies (ADAs) against DS-1055a and other antibodies.
Eligibility
Inclusion Criteria:
- Has a histopathologically documented locally advanced or metastatic head and neck, gastric, esophageal cancer, non-small cell lung cancer, or melanoma. Participants with other types of solid tumors may be eligible following discussion with the Sponsor.
- Has a relapsed or refractory disease that is not amenable to curative standard therapy.
- Is 18 years of age or older.
- 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.