TerminatedPhase 1

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

Stopped: Sponsor decision

United States17 participantsStarted 2023-10-11

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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)

Exclusion criteria

✕. 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:

What they're measuring

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

Timeframe: 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

Timeframe: Up to 21 days

Objective response rate (ORR) using RECIST 1.1

Timeframe: 2 years

Trial details

NCT IDNCT06052852

SponsorBolt Biotherapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-01

View on ClinicalTrials.gov More Triple Negative Breast Cancer trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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)

Exclusion criteria

✕. 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:

What they're measuring

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

Timeframe: 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

Timeframe: Up to 21 days

Objective response rate (ORR) using RECIST 1.1

Timeframe: 2 years