Clinical Trials /

Study of DS-7300a in Participants With Advanced Solid Malignant Tumors

NCT04145622

Description:

This study is in one single group of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts. The primary purpose of the parts are: - Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of DS-7300a. - Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of DS-7300a. This study is expected to last approximately 3.5 years from the time the first participant is enrolled to the time the last participant is off the study. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: - they withdraw - their disease gets worse - they experience unacceptable side effects.

Related Conditions:
  • Bladder Carcinoma
  • Breast Carcinoma
  • Endometrial Carcinoma
  • Esophageal Squamous Cell Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Lung Adenocarcinoma
  • Melanoma
  • Prostate Carcinoma
  • Sarcoma
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of DS-7300a in Participants With Advanced Solid Malignant Tumors
  • Official Title: Phase I/II, Two-Part, Multicenter First-in-Human Study of DS-7300a in Subjects With Advanced Solid Malignant Tumors

Clinical Trial IDs

  • ORG STUDY ID: DS7300-A-J101
  • SECONDARY ID: 194992
  • NCT ID: NCT04145622

Conditions

  • Advanced Solid Tumor
  • Malignant Solid Tumor

Interventions

DrugSynonymsArms
DS-7300aDose escalation

Purpose

This study is in one single group of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts. The primary purpose of the parts are: - Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of DS-7300a. - Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of DS-7300a. This study is expected to last approximately 3.5 years from the time the first participant is enrolled to the time the last participant is off the study. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: - they withdraw - their disease gets worse - they experience unacceptable side effects.

Trial Arms

NameTypeDescriptionInterventions
Dose escalationExperimentalAll participants enrolled in the dose escalation part
  • DS-7300a
Dose expansionExperimentalAll participants enrolled in the dose expansion part
  • DS-7300a

Eligibility Criteria

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

          -  Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid
             Tumors (RECIST) Version 1.1.

          -  Has adequate cardiac, hematopoietic, renal and hepatic functions

          -  Has an adequate treatment washout period prior to start of study treatment

        Additional Inclusion Criteria for Part 1 (Dose Escalation)

          -  Has a pathologically documented advanced/unresectable or metastatic head and neck
             squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and
             adenocarcinoma non-small cell lung cancer (NSCLC), bladder cancer, sarcoma,
             endometrial cancer, melanoma, prostate cancer, breast cancer that is refractory to or
             intolerable with standard treatment, or for which no standard treatment is available.

        Additional Inclusion Criteria for Part 2 (Dose Expansion)

          -  Has a pathologically documented advanced/unresectable or metastatic head and neck
             squamous cell carcinoma, esophageal squamous cell carcinoma, squamous-NSCLC that is
             refractory to or intolerable with standard treatment, or for which no standard
             treatment is available. Additional or alternative indications may be added to
             expansion cohorts based on preliminary signals of activity in dose escalation via a
             protocol amendment.

        Exclusion Criteria:

          -  Has prior treatment with B7-H3 targeted agent.

          -  Has prior treatment with an antibody drug conjugate that consists of an exatecan
             derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan).

          -  Has multiple primary malignancies, except adequately resected non-melanoma skin
             cancer, curatively treated in situ disease, or other solid tumors curatively treated,
             with no evidence of disease for ≥3 years.

          -  Has a medical history of myocardial infarction, symptomatic congestive heart failure
             (CHF) (New York Heart Association classes II-IV), unstable angina or serious cardiac
             arrhythmia.

          -  Has an uncontrolled infection requiring systemic therapy.

          -  Has clinically significant pulmonary compromise or requirement for supplemental
             oxygen.

          -  Has substance abuse or any other medical conditions that would increase the safety
             risk to the subject or interfere with participation of the subject or evaluation of
             the clinical study in the opinion of the Investigator.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Evaluate the incidence of dose-limiting toxicities (DLTs)
Time Frame:Day 1 to Day 21 in Cycle 1 in the dose escalation part
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Characterize the PK parameter AUClast
Time Frame:Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Safety Issue:
Description:
Measure:Characterize the PK parameter AUCtau
Time Frame:Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Safety Issue:
Description:
Measure:Characterize the PK parameter Cmax
Time Frame:Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Safety Issue:
Description:
Measure:Characterize the PK parameter Tmax
Time Frame:Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Safety Issue:
Description:
Measure:Characterize the PK parameter Ctrough
Time Frame:Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Safety Issue:
Description:
Measure:Assess the incidence of anti-drug antibodies (ADAs)
Time Frame:Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Daiichi Sankyo Co., Ltd.

Trial Keywords

  • Advanced Solid Tumor
  • Malignant Tumor
  • DS-7300a

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