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

NCT04561362 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 329

Last updated 2025-11-14

No results posted yet for this study

Summary

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).

Conditions

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

Interventions

DRUG

BT8009

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.

DRUG

Pembrolizumab

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.

Sponsors & Collaborators

  • BicycleTx Limited

    lead INDUSTRY

Principal Investigators

  • Meredith McKean, MD, MPH · Tennessee Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-17
Primary Completion
2026-03-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04561362 on ClinicalTrials.gov