Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Daiichi Sankyo
Study ID
NCT04145622
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Malignant Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ifinatamab deruxtecan (I-DXd) — DRUG
    A total anti-B7H3 antibody and MAAA-1181a

Study Details

This is a single group study 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 ifinatamab deruxtecan (I-DXd). * Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of I-DXd when administered as a single agent. This study is expected to last approximately 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.

Key Dates

Start date
Nov 3, 2019
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Oct 31, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation
    Participants with advanced solid tumors who received I-DXd IV Q3W monotherapy during dose escalation phase. Enrollment to this phase is currently closed.
  • Experimental: Dose expansion
    Currently enrolling participants with advanced solid tumors who will receive I-DXd IV Q3W monotherapy at the recommended dose for expansion.

Primary Outcome Measure

Evaluate the incidence of dose-limiting toxicities (DLTs) [ Time Frame: Day 1 to Day 21 in Cycle 1 in the dose escalation part ]

Central Contacts

  • (Japan sites) Daiichi Sankyo Contact for Clinical Trial Information
    +81-3-6225-1111(M-F 9-5 JST)
    [email protected]
  • (US sites) Daiichi Sankyo Contact for Clinical Trial Information
    908-992-6400
    [email protected]

Locations (15)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer InstituteLos AngelesCalifornia90048-
Sarah Cannon Research Institute at HealthONEDenverColorado80218
Site Coordinator
Florida Cancer SpecialistsOrlandoFlorida32804-
Florida Cancer SpecialistsSarasotaFlorida34232
Site Coordinator
Dana Farber Cancer InstituteBostonMassachusetts02115-
Henry Ford HospitalDetroitMichigan48202-
Washington UniversitySt LouisMissouri63110-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601
Site Coordinator
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
The Ohio State UniversityColumbusOhio43210-
Sidney Kimmel Cancer Center - Thomas JeffersonPhiladelphiaPennsylvania19107-
SCRI Oncology PartnersNashvilleTennessee37203-
Tennessee OncologyNashvilleTennessee37203-
MDACC (MD Anderson Cancer Center)HoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute· Los Angeles, CASarah Cannon Research Institute at HealthONE· Denver, COFlorida Cancer Specialists· Orlando, FLFlorida Cancer Specialists· Sarasota, FLDana Farber Cancer Institute· Boston, MAHenry Ford Hospital· Detroit, MI

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