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Active, Not Recruiting

NCT Number: NCT04419532

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Solid Tumor Advanced Cancer Metastatic Solid Tumor Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Princess Margaret Cancer Center, Toronto, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DS-1055a

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

Primary outcomes

  1. Number of participants with dose-limiting toxicities

    Time frame: 21 days of Cycle 1

    A dose-limiting toxicity (DLT) is defined as any treatment-emergent adverse event (TEAE) that occurs during the DLT evaluation period (21 days), excluding toxicities clearly related to disease progression or intercurrent illness or to concomitant medications or to concomitant procedures and is Grade 3 or above according to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0, with certain specified exceptions.

  2. Number of participants with adverse events

    Time frame: Baseline up to approximately 3 years

    Adverse events were assessed using National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)

  2. Time to Reach Maximum Plasma Concentration (Tmax)

    Time frame: Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)

  3. Area Under the Plasma Concentration-Time Curve Up to Last Quantifiable Time (AUClast) and During Dosing Interval (AUCtau)

    Time frame: Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)

  4. Minimum Observed Concentration (Ctrough)

    Time frame: Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)

  5. The Incidence of Anti-Drug Antibodies (ADA) and Other Antibodies

    Time frame: From pre-treatment to follow-up visit (within approximately 2 years)

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

A Phase 1, First In Human Study of DS-1055a in Subjects With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2020
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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