Study of BDC-3042 as Single Agent and in Combination With Cemiplimab in Patients With Advanced Malignancies
Part of paid clinical trials in Palo Alto, California.
- Sponsor
- Bolt Biotherapeutics, Inc.
- Study ID
- NCT06052852
- Phase
- PHASE1
- Status
- Terminated
Conditions
- Clear Cell Renal Cell Carcinoma
- Colorectal Cancer
- Head and Neck Cancer
- Melanoma
- Non-small Cell Lung Cancer
- Ovarian Cancer
- Triple Negative Breast Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- BDC-3042 — DRUGDectin-2 agonist antibody
- Cemiplimab — DRUGDrug which blocks checkpoint proteins from binding with their partner proteins, allowing T cells to kill cancer cells
Study Details
A first-in-human study using BDC-3042 as a single agent and in combination with cemiplimab in patients with advanced malignancies
Key Dates
- First listed
- Sep 25, 2023
- Start date
- Oct 11, 2023
- Status verified
- Nov 2025
- Primary completion
- Aug 1, 2025
- Completion
- Aug 1, 2025
Study Design
- Enrollment
- 17 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Single agent BDC-3042Escalating doses followed by expansion targeting advanced malignancies
- Experimental: Combination BDC-3042 plus cemiplimabEscalating doses followed by expansion targeting advanced malignancies
Primary Outcome Measure
Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to CTCAE v5.0 [ Time Frame: 2 years ]
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford Cancer Center | Palo Alto | California | 94304 | - |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
| NEXT Oncology | Austin | Texas | 78758 | - |
| MD Anderson Cancer Center | Houston | Texas | 77030 | - |
| NEXT Oncology | San Antonio | Texas | 78229 | - |
| NEXT Virginia | Fairfax | Virginia | 22031 | - |
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