A Phase 1a/b, First-in-Human Dose Escalation and Dose Expansion Clinical Study of the Dual Targeting Trop-2 and Nectin-4 Multibody Drug Conjugate BD200 in Participants With Select Unresectable Locally Advanced or Metastatic Cancers
Study Identifier:
BD200-101
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Will Be Recruiting
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Study Summary
To evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of BD200 in adult participants with advanced solid cancers.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting
Requirements information
Inclusion criteria
- * Age 18+ years * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Participant willing to provide tumor biopsies * Measurable disease per RECIST v1.1 * Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options * Satisfy requirements for prior treatments per tumor type as outlined in the protocol * Adequate organ function * Agree to contraception requirements as outlined in the protocol
Exclusion criteria
- Any major surgery or traumatic injury prior to enrollment * Unhealed wounds from surgery or injury * Received other therapies within 4 weeks prior to enrollment * Any clinically significant chronic gastrointestinal (GI) disorder * Any clinically significant ascites or liver disease * Any clinically significant pulmonary compromise * Active infection at the time enrollment * Active autoimmune disease * History or active skin disease requiring frequent treatment * Any clinically significant corneal disorder * Active known second malignancy * Any clinically significant cardiac disease * Participants with tumor abutting or eroding a major vessel * Pregnant or lactating or planning to become pregnant * Known hypersensitivity to BD200 or any of its ingredients * Unresolved toxicities from previous anticancer therapy * Participation in a concurrent clinical study in the treatment period * Part A Only: Participant with hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV) infection Note: Other inclusion and exclusion criteria may apply.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Los Angeles
Los Angeles, CA, United States, 90025
Investigator
Navid Hafez
Status
Will Be Recruiting
Condition(s) Treated at Site
Solid Tumor