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

Last updated: April 8, 2025
Sponsor: Daiichi Sankyo Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Neuroblastoma

Metastatic Cancer

Treatment

DS-1055a

Clinical Study ID

NCT04419532
DS1055-A-J101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a histopathologically documented locally advanced or metastatic head and neck,gastric, esophageal cancer, non-small cell lung cancer, or melanoma. Participantswith other types of solid tumors may be eligible following discussion with theSponsor.

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

  • Is 18 years of age or older.

  • Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1, withno 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 withthe protocol.

Exclusion

Exclusion Criteria:

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

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

  • Has a history of severe pulmonary compromise or requirement of supplemental oxygenwithin 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

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: DS-1055a
Phase: 1
Study Start date:
October 09, 2020
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • Princess Margaret Cancer Center

    Toronto, Ontario M5G 2C1
    Canada

    Site Not Available

  • National Cancer Center Hospital

    Chuo Ku, 104-0045
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, 277-8577
    Japan

    Site Not Available

  • Cancer Institute Hospital of JFCR

    Koto-Ku, 135-8550
    Japan

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

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