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Monoclonal Antibodies

BDC-1001 + Nivolumab for Breast Cancer

Q: What ails has BDC-1001 been demonstrated to ameliorate?

<p>BDC-1001 is mainly employed to treat unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, but can also be beneficial in managing microsatellite instability high, <a href="https://www.withpower.com/clinical-trials/squamous-cell-carcinoma">squamous cell carcinoma</a>, and cases of high recurrence risk.</p>

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

Patient must have an advanced solid tumor with documented HER2-protein expression or gene amplification for which approved therapies have been exhausted or are not clinically indicated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new drug, BDC-1001, as a possible treatment for HER2-positive cancer. The drug will be tested alone and in combination with another drug, nivolumab.

Who is the study for?

This trial is for adults with advanced solid tumors expressing HER2, such as certain breast, colorectal, gastroesophageal, and endometrial cancers. Participants must have tried all other approved treatments without success. They should be relatively healthy (ECOG status 0 or 1) and able to provide tumor tissue for research.Check my eligibility

What is being tested?

The study is testing BDC-1001 alone and combined with Nivolumab in patients whose tumors overexpress the HER2 protein or gene. It's a first-in-human trial aiming to find out how safe these treatments are and how well they work against different types of cancer.See study design

What are the potential side effects?

Potential side effects may include allergic reactions due to ingredients similar to trastuzumab, immune-related issues from Nivolumab like inflammation in organs or skin problems, fatigue, infusion reactions, and possibly others not yet known.

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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My advanced cancer shows HER2 protein or gene changes and no standard treatments are suitable for me.

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My advanced cancer shows HER2 activity and I've tried all other approved treatments.

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I am fully active or can carry out light work.

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 dose-limiting toxicities (DLTs)

Maximum tolerable dose (MTD) or a tolerated dose below MTD

Objective response rate (ORR) of confirmed complete or partial responses (CR, PR)

Secondary outcome measures

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

Duration of response (DOR)

Incidence of adverse events (AEs) and serious adverse events (SAEs)

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Single agent BDC-1001Experimental Treatment1 Intervention

Escalating doses followed by expansion targeting HER2-expressing advanced malignancies

Group II: Combination BDC-1001 plus nivolumabExperimental Treatment2 Interventions

Escalating doses followed by expansion targeting HER2-expressing advanced malignancies

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bolt Biotherapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

233 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,640 Previous Clinical Trials

4,129,074 Total Patients Enrolled

51 Trials studying Breast Cancer

8,265 Patients Enrolled for Breast Cancer

Bolt Clinical DevelopmentStudy DirectorBolt Biotherapeutics

2 Previous Clinical Trials

233 Total Patients Enrolled

Media Library

BDC-1001 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04278144 — Phase 1 & 2

Breast Cancer Research Study Groups: Single agent BDC-1001, Combination BDC-1001 plus nivolumab

Breast Cancer Clinical Trial 2023: BDC-1001 Highlights & Side Effects. Trial Name: NCT04278144 — Phase 1 & 2

BDC-1001 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04278144 — Phase 1 & 2

Frequently Asked Questions

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

Are there any open enrollment opportunities for this research endeavor?

"Affirmative. The data hosted on clinicaltrials.gov reflects that this medical research project, initially posted February 24th 2020, is currently seeking participants. 390 patients are needed to be recruited from 15 different trial sites."

Answered by AI

Have any other investigations used BDC-1001 as part of their research?

"At the moment, 1633 clinical trials concerning BDC-1001 are currently in progress. Out of these studies, 200 have reached Phase 3 and most were conducted in Houston, Texas; though 72999 locations globally are running similar tests with this medication."

Answered by AI

What is the primary aim of this research endeavor?

"According to the trial sponsor, Bolt Biotherapeutics Inc., the primary outcome that will be measured over 21 days is Objective Response Rate (ORR) for complete or partial responses (CR/PR). Secondary objectives include examining peak concentration of BDC-1001 as monotherapy and in combination with pembrolizumab during both escalation and expansion periods, area under curve concentration of BDC-10001 as monotherapy and in combination with pembrozilmab also across both stages, along with a separate overall response rate assessment using RECIST 1.1 and iRECIST only applicable during the escalation phase."

Answered by AI

How many facilities are offering this experimental program?

"Fifteen clinical sites are currently recruiting patients for this study, including Arizona Oncology in Tucson, Memorial Sloan-Kettering Cancer Center in New york and Levine Cancer Institute in Charlotte. Additionally, there are a dozen other locations that have joined the trial."

Answered by AI

What ails has BDC-1001 been demonstrated to ameliorate?

"BDC-1001 is mainly employed to treat unresectable melanoma, but can also be beneficial in managing microsatellite instability high, squamous cell carcinoma, and cases of high recurrence risk."

Answered by AI

What is the current enrollment rate for this medical trial?

"Bolt Biotherapeutics, Inc. is running this trial from multiple sites with a total of 390 participants that meet the inclusion criteria needed for successful operation. Enrollees can be found at Arizona Oncology in Tucson, Arizona and Memorial Sloan-Kettering Cancer Center in New york, North carolina."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors

2020. "A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04278144.

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