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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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)

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Single agent BDC-3042Experimental Treatment1 Intervention

Escalating doses followed by expansion targeting advanced malignancies

Group II: Combination BDC-3042 plus pembrolizumabExperimental Treatment2 Interventions

Escalating doses followed by expansion targeting advanced malignancies

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bolt Biotherapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

456 Total Patients Enrolled

Bolt Clinical DevelopmentStudy DirectorBolt Biotherapeutics

2 Previous Clinical Trials

456 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for participants in this clinical trial?

"According to the information on clinicaltrials.gov, recruitment for this study is underway after first being posted on October 1st 2023 and updated as recently as September 19th of the same year."

Answered by AI

How many participants are registered for this trial?

"Affirmative. According to clinicaltrials.gov, this trial commenced on October 1st 2023 and was most recently updated on September 19th 2023. Currently 167 participants are needed from 3 medical facilities for the study to move forward."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of BDC-3042 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06052852.

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