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

Last updated: March 18, 2026
Sponsor: Daiichi Sankyo
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Neuroblastoma

Neoplasm Metastasis

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:
July 01, 2027

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

    Chūōku, 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

  • Cancer Institute Hospital of JFCR

    Kōtoku, 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

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.