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BDC-3042 + Pembrolizumab for Advanced Cancers

Phase 1 & 2

Recruiting

Research Sponsored by Bolt Biotherapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Histologically/cytologically confirmed 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.

Must not have

Prior hospitalization for asthma during past year

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, BDC-3042, as a stand-alone treatment and combined with pembrolizumab to treat advanced cancers.

Who is the study for?

Adults with certain advanced cancers (like ovarian, lung, breast, head and neck, renal cell carcinoma or colorectal cancer) that have worsened despite standard treatments. They must be in relatively good health otherwise, not planning to conceive (or will use effective contraception), and have no serious heart issues or other conditions that could interfere with the trial.

What is being tested?

The study is testing BDC-3042 alone and combined with Pembrolizumab to see how well they work against various advanced cancers. It's a first-in-human trial meaning it's the first time these drugs are being tested in people for safety and effectiveness.

What are the potential side effects?

Potential side effects may include immune system reactions leading to inflammation in different body parts, infusion-related reactions similar to allergic responses during drug administration, fatigue, possible liver enzyme changes indicating liver stress or damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have advanced cancer with no standard treatment options left.

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I am using a highly effective birth control method during and 4 weeks after treatment.

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I am 18 years old or older.

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Your blood, kidneys, and liver must be working well within certain levels, and your blood clotting should also be normal, unless you are already on blood-thinning medication.

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My cancer has worsened despite all standard treatments.

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My cancer is advanced and has not responded to standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was hospitalized for asthma in the last year.

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I do not have an active infection or HIV, hepatitis B, or C.

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I have a history of HLH/MAS.

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I haven't taken any experimental drugs within the last 28 days.

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I do not have any ongoing bowel issues like perforation, fistula, or abscess.

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I have not had radiation therapy in the last 14 days.

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I have not received a live vaccine in the last 28 days.

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I have liver disease causing symptoms like fluid in the abdomen, confusion, bleeding problems, swollen veins in my esophagus or stomach, or ongoing yellowing of my skin and eyes.

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I have had a bone marrow or solid organ transplant.

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I have a lung condition that affects my daily life or needed hospital care recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

Duration of response (DOR)

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