NCT06052852

Study of BDC-3042 as Single Agent and in Combination With Cemiplimab in Patients With Advanced Malignancies

A Phase 1/2, First-in-Human, Dose Escalation and Expansion Study of BDC-3042 as a Single Agent and in Combination With Cemiplimab in Patients With Advanced Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Bolt Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A first-in-human study using BDC-3042 as a single agent and in combination with cemiplimab in patients with advanced malignancies

Detailed description

This is a 4-part dose escalation and dose expansion study of BDC-3042 as a single agent and in combination with cemiplimab in patients with advanced malignancies. Phase 1 includes two separate parts: a dose escalation study to evaluate BDC-3042 as a single agent (Part 1) and a combination dose escalation study with cemiplimab (Part 2) to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), or maximum protocol dose (MPD). Dependent on the results of Phase 1, the study may proceed into Phase 2. Phase 2 is a dose expansion study of BDC-3042 as a single agent (Part 3) and in combination with cemiplimab (Part 4) at the MTD, RP2D or MPD.

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

Type	Name	Description
DRUG	BDC-3042	Dectin-2 agonist antibody
DRUG	Cemiplimab	Drug which blocks checkpoint proteins from binding with their partner proteins, allowing T cells to kill cancer cells

Timeline

• Start date: 2023-10-11
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2023-09-25
• Last updated: 2025-11-17

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study