Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
BicycleTx Limited
Study ID
NCT05163041
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • BT7480 — DRUG
    Participants will receive a 60 minute IV infusion of BT7480 once weekly (i.e., on Days 1,8,15 and 22) during a 28-day cycle
  • Nivolumab — DRUG
    Nivolumab will be given as a 240mg dose every 2 weeks administered as per local labelling as a 30 minute IV infusion

Study Details

This clinical study is evaluating a drug called BT7480 alone and in combination with nivolumab in participants with advanced solid tumors associated with Nectin-4 expression. The main goals of the study are to: * Find the recommended dose of BT7480 that can be given safely to participants alone and in combination with nivolumab * Learn about the side effects and effectiveness of BT7480 alone and in combination with nivolumab * Learn about the effect BT7480 has on the body and how BT7480 is cleared by the body * Learn about the side effects and effectiveness of BT7480 in patients with reduced kidney function

Key Dates

Start date
Nov 2, 2021
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: BT7480 monotherapy dose escalation
    Participants will receive increasing doses of BT7480. It is expected that approximately 80 patients will participate in this dose escalation arm.
  • Experimental: BT7480 and nivolumab dose escalation
    Participants will receive increasing doses of BT7480 and standard dose of nivolumab. It is expected that approximately 12 patients will participate in this dose escalation arm.
  • Experimental: BT7480 monotherapy dose expansion
    Participants will receive a selected dose of BT7480. It is expected that approximately 45 patients will participate in this dose expansion arm in Phase 2.
  • Experimental: BT7480 and nivolumab dose expansion
    Participants will receive a selected dose of BT7480 and standard dose of nivolumab. It is expected that approximately 45 patients will participate in this dose expansion arm in Phase 2.
  • Experimental: BT7480 monotherapy in patients with renal insufficiency
    Participants will receive a selected dose of BT7480. It is expected that approximately 12 patients will participate in this dose confirmation arm.

Primary Outcome Measure

Number of patients with treatment emergent adverse events in dose escalation phase [ Time Frame: From Cycle 1 Day 1 (each cycle is 28 days) until 30 (+/-5) days after the last dose of study drug ]

Locations (7)

FacilityCityStateZIPSite coordinators
State University of IowaIowa CityIowa52242-
Columbia University Irving Medical CenterNew YorkNew York10032-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
MD Anderson Cancer CenterHoustonTexas77030-
START Center for Cancer CareSan AntonioTexas78229-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Iowa City, IA

By research site
State University of Iowa· Iowa City, IAColumbia University Irving Medical Center· New York, NYUniversity Hospitals Cleveland Medical Center· Cleveland, OHFox Chase Cancer Center· Philadelphia, PAMD Anderson Cancer Center· Houston, TXSTART Center for Cancer Care· San Antonio, TX

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