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

Stopped early · Phase 1

Conditions studied: Triple Negative Breast Cancer, Clear Cell Renal Cell Carcinoma, Ovarian Cancer, Head and Neck Cancer, Colorectal Cancer, Non-small Cell Lung Cancer, Melanoma

In brief

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

Key facts

Study ID

NCT06052852

Run by

Bolt Biotherapeutics, Inc.

People needed

17

Starts

2023-10-11

Expected to finish

2025-08-01

Last updated by the study team

2025-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Progestin-only hormonal contraception that inhibits ovulation
• Intrauterine device
• Vasectomized partner
• Sexual abstinence
• Intrauterine hormone-releasing system
• Bilateral tubal occlusion Note: For WOCBP with breast cancer, alternative non-hormonal contraceptive measures are recommended (c, d, e, g).
• Potent men that are partners of WOCBP must be willing to use condoms in combination with a second highly effective method of female contraception and agree not to donate sperm from screen through at least 4 months after last dose of study treatment. A male partner will be considered as potent unless surgically sterilized (with appropriate documentation of sterility).

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
• Infection including:
• Disease requiring systemic therapy within 7 days before starting study treatment
• Ongoing COVID-19 as determined by viral testing
• Active human immunodeficiency virus (HIV) infection as determined at screening
• Active hepatitis B infection as determined at screening
• Active hepatitis C infection as determined at screening
• Autoimmune disease requiring systemic disease-modifying or immunosuppressive therapy within 2 years before starting study treatment. Exceptions include disease managed with only replacement therapies (eg, thyroxine, etc.)
• History of hemophagocytic lymphohistiocytosis/macrophage activation syndrome
• Malignancy within 2 years before starting study treatment other than the disease under study. Exceptions include indolent or definitively treated disease not expected to require treatment during the study, affect the safety of subjects, or affect the endpoints of the trial
• Any medical condition requiring corticosteroids (> 10 mg daily oral prednisone or equivalent) or other systemic immunosuppressive therapy within 28 days before starting study treatment. Exception: Intermittent or sporadic use of inhaled or topical steroids is allowed

Where it is running

• Stanford Cancer Center — Palo Alto, California, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• NEXT Oncology — Austin, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• NEXT Oncology — San Antonio, Texas, United States
• NEXT Virginia — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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