Study of BDC-3042 as Single Agent and in Combination With Cemiplimab in Patients With Advanced Malignancies
← catalyst calendarSponsored by Bolt Biotherapeutics, Inc. (industry) · BOLT — their whole pipeline →. With Regeneron Pharmaceuticals.
Phase
Phase 1
Status
Terminated
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
17actual
Sites
6
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Sponsor decision
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-10-11 | actual | When the study began enrolling |
| Primary completion | 2025-08-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-08-01 | actual | The whole study's end, after follow-up |
| First posted | 2023-09-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Triple Negative Breast Cancer
- Clear Cell Renal Cell Carcinoma
- Ovarian Cancer
- Head and Neck Cancer
- Colorectal Cancer
- Non-small Cell Lung Cancer
- Melanoma
Interventions
- Drug: BDC-3042
- Drug: Cemiplimab — also filed as Libtayo, Immune checkpoint inhibitor
Primary outcomes
what the primary-completion date above is the date OFIncidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to CTCAE v5.0
measured 2 years
Incidence and nature of AEs considered by the Investigator or Sponsor to be clinically relevant, attributable to study treatment, and meeting dose-limiting toxicity (DLT) criteria
measured Up to 21 days
Objective response rate (ORR) using RECIST 1.1
measured 2 years
Permalink · BOLT's whole pipeline · Catalyst calendar · Every registered study · What changed