A First-in-human Study Using BDC-1001 in Advanced and HER2-Expressing Solid Tumors
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- STATUS
- Recruiting
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- participants needed
- 390
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- sponsor
- Bolt Biotherapeutics, Inc.
Summary
A first-in-human study using BDC-1001 in HER2 expressing advanced malignancies
Description
This study has four parts. Part 1 is a dose escalation of BDC-1001 as a single agent to determine the maximum tolerated dose (MTD) recommended for Part 3 and Phase 2 (RP2D). In Part 3, the selected dose will be administered as monotherapy to patients with selected advanced malignancies. Part 2 is a dose escalation of BDC-1001 in combination with pembrolizumab to determine the maximum tolerated dose (MTD) recommended for Part 4 and Phase 2 (RP2D). In Part 4, the selected dose will be administered in combination with pembrolizumab to patients with selected advanced malignancies.
Details
| Condition | Breast Cancer, Breast Cancer, Gastric Cancer, Gastric Cancer, Neoplasm, Metastatic |
|---|---|
| Age | 18-100 years |
| Treatment | Pembrolizumab, BDC-1001 |
| Clinical Study Identifier | NCT04278144 |
| Sponsor | Bolt Biotherapeutics, Inc. |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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