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

NCT06052852 | Terminated Phase 1 FDA Drug

• 1 other identifier: BBI-20233042
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Triple Negative Breast Cancer; Clear Cell Renal Cell Carcinoma; Ovarian Cancer; Head and Neck Cancer; Colorectal Cancer; Non-small Cell Lung Cancer; Melanoma

Outcome Measures

Primary Outcomes (3)

• Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to CTCAE v5.0

  Escalation period

  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

  Escalation period

  Up to 21 days

• Objective response rate (ORR) using RECIST 1.1

  Expansion period

  2 years

Secondary Outcomes (14)

• Objective response rate (ORR) using RECIST 1.1

  2 years

• Duration of response (DOR)

  2 years

• Disease control rate (DCR) of confirmed complete response (CR), partial response (PR), or stable disease (SD) lasting 4 or more weeks

  2 years

• Progression Free Survival (PFS)

  2 years

• Best overall response (CR, PR, SD, progressive disease)

  2 years

Study Arms (2)

Single agent BDC-3042

EXPERIMENTAL

Escalating doses followed by expansion targeting advanced malignancies

Drug: BDC-3042

Combination BDC-3042 plus cemiplimab

EXPERIMENTAL

Escalating doses followed by expansion targeting advanced malignancies

Drug: BDC-3042; Drug: Cemiplimab

Interventions

BDC-3042 DRUG

Dectin-2 agonist antibody

Combination BDC-3042 plus cemiplimab; Single agent BDC-3042

Cemiplimab DRUG

Drug which blocks checkpoint proteins from binding with their partner proteins, allowing T cells to kill cancer cells

Also known as: Libtayo, Immune checkpoint inhibitor

Combination BDC-3042 plus cemiplimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and sign the informed consent form
• Age 18 years or older at the time of informed consent
• Has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Subjects enrolled in Part 1 and Part 2 dose escalation cohorts must have:
• a. Histologically/cytologically confirmed melanoma, triple-negative breast cancer (TNBC), clear cell renal cell cancer (ccRCC), ovarian cancer, head and neck cancer, colorectal cancer, or non-small cell lung cancer (NSCLC) that is metastatic or unresectable with tumor progression after standard therapy who have no options for standard therapies which are known to confer clinical benefit. Subjects with ovarian cancer must have platinum resistant or platinum- refractory tumors.
• Subjects enrolled in Part 3 and Part 4 dose expansion cohorts must have histologically/cytologically confirmed metastatic or unresectable disease with tumor progression after standard therapy.
• Adequate organ function defined as follows:
• Hematology: i. Absolute neutrophil count ≥ 1500 cells/mm3; ii. Platelet count ≥ 75,000 cells/mm3 (without transfusion for 14 days); iii. Hemoglobin ≥ 9 g/dL (and without transfusion within 14 days)
• Renal: creatinine clearance ≥ 30 mL/min by Cockcroft-Gault estimate
• Coagulation: Prothrombin time or international normalized ratio and activated partial thromboplastin time ≤ 1.5 × upper limit of normal (ULN) (unless receiving anticoagulation therapy)
• Hepatic: i. Aspartate aminotransferase and alanine transaminase (ALT) ≤ 3 × ULN (or ≤ 5 × ULN in subjects with known hepatic metastases); ii. Total bilirubin ≤ 1.5 × ULN (isolated value \> 1.5 × ULN is acceptable if direct bilirubin is \< 35% of total)
• Expected life expectancy of \> 12 weeks per the Investigator
• Women of childbearing potential (WOCBP) must use a highly effective contraceptive measure (a method that can achieve a failure rate of less than 1% per year) during treatment and until 4 months after the end treatment, such as:
• Estrogen and progestin containing hormonal contraception that inhibits ovulation

You may not qualify if:

• Active systemic yeast infection within 4 weeks before study treatment
• Prior hospitalization for asthma during past year
• Central nervous system metastases except for disease that is asymptomatic, clinically stable, and has not required steroids for at least 28 days before starting study treatment
• Cardiac disease including:
• Congestive heart failure New York Heart Association classes II-IV
• QTcF prolongation \> 480 milliseconds (ms) based on a 12-lead electrocardiogram (ECG)
• Serious or uncontrolled cardiac arrhythmia within 6 months before starting study treatment
• Myocardial infarction, unstable angina pectoris, or coronary angioplasty, stenting, or surgery within 6 months before starting study treatment
• Uncontrolled hypertension (≥ 180 mmHg systolic or ≥ 120 mmHg diastolic)
• Pericarditis or pericardial effusion that is symptomatic within 6 months before starting study treatment
• Pulmonary disease including idiopathic pulmonary fibrosis, noninfectious interstitial lung disease, pneumonitis, chronic obstructive pulmonary disease (requiring daily treatment for dyspnea, oxygen therapy on an ongoing basis, or hospitalization within the past 6 months)
• Hepatic disease resulting in symptomatic ascites, encephalopathy, coagulopathy, esophageal/gastric varices, or persistent jaundice
• Arterial thrombotic event, stroke, or transient ischemia attack within 6 months before starting study treatment
• Clinically significant bleeding diathesis or uncontrolled bleeding within 7 days before starting study treatment
• Bone marrow transplant or solid organ transplant

Sponsors & Collaborators

• Bolt Biotherapeutics, Inc.: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (6)

Stanford Cancer Center

Palo Alto, California, 94304, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

NEXT Oncology

Austin, Texas, 78758, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

NEXT Virginia

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Carcinoma, Renal Cell; Ovarian Neoplasms; Head and Neck Neoplasms; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Melanoma

Interventions

cemiplimab; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Bolt Clinical Development

  Bolt Biotherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiple ascending dose and dose-expansion of BDC-3042 administered as a single agent or in combination with cemiplimab

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 25, 2023
• Study Start: October 11, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

US (6)