Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies

Part of paid clinical trials in Denver, Colorado.

Sponsor
BicycleTx Limited
Study ID
NCT04561362
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Solid Tumor
  • Breast Neoplasms
  • Hormone Receptor Positive, HER2-low Neoplasms
  • Hormone Receptor Positive, HER2-negative Neoplasms
  • Non-Small-Cell Lung Neoplasms
  • Ovarian Neoplasm
  • Triple Negative Breast Neoplasms
  • Urinary Bladder Neoplasm

Eligibility Criteria

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

Interventions

  • BT8009 — DRUG
    Bicyclic Toxin Conjugate (BTC) administered either weekly (i.e., on Days 1, 8, 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle for participants in A-1. Participants in Cohorts A-2 and B-7 will receive BT8009 weekly on 21-day cycle. Participants in Parts B-1-B-6 will receive BT8009 weekly either on a 21-day or 28-day cycle. Participants in Parts B-8 and B-9 will receive BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive BT8009 once weekly (i.e., on Days 1, 8, 15, and 22) on a 28-day cycle. Participants in Part D will receive BT8009 once weekly on a 28-day cycle.
  • Pembrolizumab — DRUG
    Participants in Cohorts A-2 and B-7 will receive 200 mg IV over 30-minute infusion of pembrolizumab on Day 1 of each Q3W.

Study Details

This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency. The primary endpoints are: Dose limiting toxicities (Parts A-1 and A-2), Overall response rate per RECIST v1.1 (Parts B1-B7), Safety and tolerability (Parts B-8, B-9 and C), and characterization of the pharmacokinetics (Part D).

Key Dates

Start date
Jul 17, 2020
Status verified
Nov 2025
Primary completion
Mar 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Part A-1 -BT8009 Monotherapy Dose Escalation
    Participants will receive escalating doses of BT8009.
  • Experimental: Part A-2 -BT8009 in Combination with Pembrolizumab Dose De-Escalation
    Participants will receive BT8009 and a standard dose of pembrolizumab.
  • Experimental: Cohort B-1 - BT8009 Monotherapy Dose Expansion
    Participants will receive a selected dose of BT8009.
  • Experimental: Cohort B-2- BT8009 Monotherapy Dose Expansion
    Participants will receive a selected dose of BT8009.
  • Experimental: Cohort B-3- BT8009 Monotherapy Dose Expansion
    Participants will receive a selected dose of BT8009. .
  • Experimental: Cohort B-4- BT8009 Monotherapy Dose Expansion
    Participants will receive a selected dose of BT8009.
  • Experimental: Cohort B-5- BT8009 Monotherapy Dose Expansion
    Participants will receive a selected dose of BT8009.
  • Experimental: Cohort B-6- BT8009 Monotherapy Dose Expansion
    Participants will receive a selected dose of BT8009.
  • Experimental: Cohort B-7- BT8009 in Combination with Pembrolizumab Dose Expansion
    Participants will receive a selected dose of BT8009 and standard dose of pembrolizumab.
  • Experimental: Part C - Renal Insufficiency BT8009 Monotherapy Dose Expansion
    Participants will receive a selected dose of BT8009.
  • Experimental: Part D - BT8009 Monotherapy Supplementary PK
    Participants will receive a selected dose of BT8009.
  • Experimental: Part B-8 - BT8009 Monotherapy Dose Expansion
    Participants will receive a selected dose of BT8009.
  • Experimental: Part B-9 - BT8009 Monotherapy Dose Expansion
    Participants will receive a selected dose of BT8009.

Primary Outcome Measure

Parts A-1, A-2 and C: Number of participants with treatment emergent adverse events, receiving BT8009 as a monotherapy or in combination with pembrolizumab to assess safety and tolerability. [ Time Frame: From cycle 1 day 1 until 30 days after the end of treatment or approximately 1 year ]

Locations (9)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute at HealthONEDenverColorado80218-
Ocala Oncology CenterOcalaFlorida34474-
Advent HealthOrlandoFlorida34747-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107-
Tennessee Oncology, PLLCNashvilleTennessee37203-
Mary Crowley Cancer Research CenterDallasTexas75230-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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By research site
Sarah Cannon Research Institute at HealthONE· Denver, COOcala Oncology Center· Ocala, FLAdvent Health· Orlando, FLIcahn School of Medicine at Mount Sinai· New York, NYUniversity Hospitals Cleveland Medical Center· Cleveland, OHThomas Jefferson University, Sidney Kimmel Cancer Center· Philadelphia, PA

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