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

> **NCT04278144** · PHASE1,PHASE2 · TERMINATED · sponsor: **Bolt Biotherapeutics, Inc.** · enrollment: 175 (actual)

## Conditions studied

- HER2-positive Solid Tumors
- HER2-positive Breast Cancer
- HER2-positive Colorectal Cancer
- HER2-positive Gastroesophageal Cancer
- HER2-positive Endometrial Cancer

## Interventions

- **DRUG:** BDC-1001
- **DRUG:** Nivolumab

## Key facts

- **NCT ID:** NCT04278144
- **Lead sponsor:** Bolt Biotherapeutics, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2020-02-24
- **Primary completion:** 2024-12-10
- **Final completion:** 2025-02-14
- **Target enrollment:** 175 (ACTUAL)
- **Why stopped:** Sponsor Decision
- **Last updated:** 2025-09-15

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04278144

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04278144, "A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors". Retrieved via AI Analytics 2026-07-17 from https://api.ai-analytics.org/clinical/NCT04278144. Licensed CC0.

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