A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors

Part of paid clinical trials in Palo Alto, California.

Sponsor
Bolt Biotherapeutics, Inc.
Study ID
NCT04278144
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • HER2-positive Breast Cancer
  • HER2-positive Colorectal Cancer
  • HER2-positive Endometrial Cancer
  • HER2-positive Gastroesophageal Cancer
  • HER2-positive Solid Tumors

Eligibility Criteria

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

Interventions

  • BDC-1001 — DRUG
    Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
  • Nivolumab — DRUG
    Programmed death receptor-1 (PD 1)-blocking antibody

Study Details

A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies

Key Dates

Start date
Feb 24, 2020
Status verified
Sep 2025
Primary completion
Dec 10, 2024
Completion
Feb 14, 2025

Study Design

Enrollment
175 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Single agent BDC-1001
    Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
  • Experimental: Combination BDC-1001 plus nivolumab
    Escalating doses followed by expansion targeting HER2-expressing advanced malignancies

Primary Outcome Measure

Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 2 years ]

Locations (11)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
The University of Chicago Medical CenterChicagoIllinois60637-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
START MidwestGrand RapidsMichigan49546-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Stephenson Cancer CenterOklahoma CityOklahoma73104-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research TherapeuticsSan AntonioTexas78229-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Palo Alto, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Stanford University· Palo Alto, CAGeorgetown University Medical Center· Washington D.C., DCThe University of Chicago Medical Center· Chicago, ILDana-Farber Cancer Institute· Boston, MASTART Midwest· Grand Rapids, MIMemorial Sloan-Kettering Cancer Center· New York, NY

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