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Triple Negative Breast CancerPhase 1NCT06052852

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

A Phase 1 study testing BDC-3042 and Cemiplimab in people with Triple Negative Breast Cancer and Clear Cell Renal Cell Carcinoma, run by Bolt Biotherapeutics, Inc. at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
BDC-3042 and Cemiplimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
6 sitesUnited States
Study dates
11 Oct 2023to 1 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.
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  • 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).

Who cannot join

  • 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)
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  • 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
  • Residual toxicity from previous treatment including:
  • Toxicity related to prior treatment not resolved to Grade 1, except for alopecia or dysgeusia
  • Neuropathy Grade > 2 Note: Exceptions to the above criteria include toxicities that do not pose a risk to vital organ systems (eg, alopecia) or toxicities that are stable as managed by replacement therapies (eg, hypothyroidism)
  • Subjects receiving cemiplimab: those that have permanently discontinued immuno- modulating therapies due to drug-related toxicity.
  • Subjects receiving cemiplimab: hypersensitivity to cemiplimab or any of its excipients or contraindicated to cemiplimab per approved local labeling
  • Any investigational agent within 28 days before starting study treatment or within 5 estimated elimination half-lives, whichever is shorter
  • Radiation therapy within 14 days before starting study treatment
  • History of severe hypersensitivity to any ingredient of BDC-3042 or study treatment (as applicable for combination study treatment)
  • Received live/attenuated virus vaccine within 28 days before starting study treatment
  • Major surgery within 28 days of starting study treatment (consult with Medical Monitor)
  • Actively enrolled in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up component of an interventional study
  • Patient is a lactating mother or pregnant as confirmed by pregnancy tests within 7 days prior to start of study treatment
  • Patient is unwilling or unable to follow protocol requirements
  • Ongoing bowel perforation or presence of bowel fistula or intra-abdominal abscess
  • Any condition that, in the opinion of the Investigator, would interfere with evaluation of BDC-3042 or interpretation of the patient's safety or study results

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • NEXT Oncology

    Austin, Texas, 78758

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • NEXT Virginia

    Fairfax, Virginia, 22031

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Stanford Cancer Center

    Palo Alto, California, 94304

  • NEXT Oncology

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: 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

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

Read the 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.

Being tested
BDC-3042, Cemiplimab
Medical subject headings
Triple Negative Breast Neoplasms, Carcinoma, Renal Cell, Ovarian Neoplasms, Head and Neck Neoplasms, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BDC-3042Drug

    Dectin-2 agonist antibody

  • CemiplimabDrug

    Also called Libtayo, Immune checkpoint inhibitor

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

Study groups in NCT06052852
Study groupRoleWhat they receive
Single agent BDC-3042ExperimentalEscalating doses followed by expansion targeting advanced malignancies
Receives: Drug: BDC-3042
Combination BDC-3042 plus cemiplimabExperimentalEscalating doses followed by expansion targeting advanced malignancies
Receives: Drug: BDC-3042; Drug: Cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Escalation period

    Measured: 2 years

  2. 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

    Measured: Up to 21 days

  3. Objective response rate (ORR) using RECIST 1.1

    Expansion period

    Measured: 2 years

Secondary outcomes (14)

  1. Objective response rate (ORR) using RECIST 1.1

    Escalation period

    Measured: 2 years

  2. Duration of response (DOR)

    Escalation and expansion periods

    Measured: 2 years

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

    Escalation and expansion periods

    Measured: 2 years

  4. Progression Free Survival (PFS)

    Escalation and expansion periods

    Measured: 2 years

  5. Best overall response (CR, PR, SD, progressive disease)

    Expansion period

    Measured: 2 years

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

    Expansion period

    Measured: 2 years

  7. PK (Cmax) of BDC-3042

    Escalation and expansion periods

    Measured: 2 years

  8. PK (Cmin) of BDC-3042

    Escalation and expansion periods

    Measured: 2 years

  9. PK (AUC0-t) of BDC-3042

    Escalation and expansion periods

    Measured: 2 years

  10. PK (AUC0-inf) of BDC-3042

    Escalation and expansion periods

    Measured: 2 years

  11. PK (CL) of BDC-3042

    Escalation and expansion periods

    Measured: 2 years

  12. PK (Vc or Vss) of BDC-3042

    Escalation and expansion periods

    Measured: 2 years

  13. PK (Terminal t1/2) of BDC-3042

    Escalation and expansion periods

    Measured: 2 years

  14. Incidence of anti-BDC-3042 antibodies

    Escalation and expansion periods

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2023
  2. Study start11 Oct 2023
  3. Primary completion1 Aug 2025
  4. Study completion1 Aug 2025

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Multiple ascending dose and dose-expansion of BDC-3042 administered as a single agent or in combination with cemiplimab
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06052852
Sponsor's protocol ID
BBI-20233042
Status last verified
Nov 2025
First submitted
13 Sep 2023
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BDC-3042 and Cemiplimab in people with Triple Negative Breast Cancer and Clear Cell Renal Cell Carcinoma, run by Bolt Biotherapeutics, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to CTCAE v5.0 (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06052852.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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