BDC-1001 + Nivolumab for Breast Cancer

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Bolt Biotherapeutics, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests a new drug, BDC-1001, alone and with another drug, in patients with advanced HER2-positive cancers. BDC-1001 aims to attack cancer cells directly, and the other drug boosts the immune system to fight the cancer.

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

I am fully active or can carry out light work.

Exclusion Criteria

I currently have COVID-19.

I have not received treatment for tumors or cancer spread to my brain or spinal cord.

I have HIV, active hepatitis B, or hepatitis C.

I have a history of heart problems.

I have been treated with a TLR 7, TLR 8, or TLR 7/8 agonist before.

Treatment Details

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.

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