Clinical Trials /

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

NCT04419532

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors
  • Official Title: A Phase 1, First In Human Study of DS-1055a in Subjects With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: DS1055-A-J101
  • NCT ID: NCT04419532

Conditions

  • Solid Tumor
  • Advanced Cancer
  • Metastatic Solid Tumor

Interventions

DrugSynonymsArms
DS-1055aDose Escalation (DS-1055a)

Purpose

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.

Detailed 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, incidence of anti-drug antibodies (ADAs) against
      DS-1055a, and the effect of DS-1055a on tumor-infiltrating lymphocyte profile.
    

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation (DS-1055a)ExperimentalParticipants will receive escalating doses of DS-1055a (starting dose 0.3 mg/kg every 3 weeks).
  • DS-1055a

Eligibility Criteria

        Inclusion Criteria:

          -  Has a histopathologically documented locally advanced or metastatic head and neck,
             gastric, or esophageal cancer, or the other types of solid tumors.

          -  Has a relapsed or refractory disease that is not amenable to curative standard
             therapy.

          -  Is 18 years of age or older (or complies with country-specific regulatory
             requirements, at least 20 years of age in Japan).

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with dose-limiting toxicities
Time Frame:21 days of Cycle 1
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Maximum Serum Concentration (Cmax)
Time Frame: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)
Safety Issue:
Description:
Measure:Time to Reach Maximum Serum Concentration (Tmax)
Time Frame: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)
Safety Issue:
Description:
Measure:Area Under the Serum Concentration-Time Curve Up to Last Quantifiable Time (AUClast) and During Dosing Interval (AUCtau)
Time Frame: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)
Safety Issue:
Description:
Measure:Minimum Observed Concentration (Ctrough)
Time Frame: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)
Safety Issue:
Description:
Measure:The Incidence of Anti-Drug Antibodies (ADA)
Time Frame:From pre-treatment to end of treatment (within approximately 2 years)
Safety Issue:
Description:
Measure:The Change in the Number of Tumor-infiltrating Lymphocytes (TIL) From Baseline
Time Frame:From pre-treatment to end of treatment (within approximately 2 years)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Daiichi Sankyo Co., Ltd.

Trial Keywords

  • Solid Tumor
  • Advanced Cancer
  • Metastatic Solid Tumor
  • DS-1055a

Last Updated

October 16, 2020