A Phase 1, first in human study of DS-1055a in subjects with relapsed or refractory locally advanced or metastatic solid tumors

Phase 1

Completed

Conditions: locally advanced or metastatic head and neck cancer, gastric cancer, esophageal cancer, non-small cell lung cancer, or melanoma

Recruitment & Eligibility

Inclusion Criteria

Has a histopathologically documented locally advanced or metastatic head and neck, gastric, or 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.
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. Subjects 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.

Study Design: This is a Phase 1, multicenter, open-label, dose escalation, first in human study will evaluate the safety and tolerability of DS-1055a administered by IV infusion as a single agent to subjects with locally advanced or metastatic head and neck cancer, gastric cancer, esophageal cancer, non-small cell lung cancer, or melanoma.

Primary Outcome Measures

Name	Time	Method
safety		To assess the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose of DS-1055a for further investigation

Secondary Outcome Measures

Name	Time	Method
pharmacokinetics		- To assess pharmacokinetic (PK) properties of DS-1055a
incidence of anti-drug antibodies		- To assess the incidence of anti-drug antibodies (ADA) against DS-1055a and of other antibodies.