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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-09

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Solid Tumor Advanced Cancer Metastatic Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation (DS-1055a)

Participants will be enrolled into groups with each group receiving an increased dose from the previous group as safety assessments permit in order to determine the optimal dose for safety and tolerability.

Group Type EXPERIMENTAL

DS-1055a

Intervention Type DRUG

Administered as an intravenous infusion on Day 1 of every 21-day cycle following low dose administration(s) in priming dose period.

Infusion duration: 180 minutes for the first infusion, and if no infusion-related reaction, 120 minutes for subsequent infusions

Interventions

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DS-1055a

Administered as an intravenous infusion on Day 1 of every 21-day cycle following low dose administration(s) in priming dose period.

Infusion duration: 180 minutes for the first infusion, and if no infusion-related reaction, 120 minutes for subsequent infusions

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No