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Bolt Biotherapeutics (BOLT)
NASDAQ:BOLT
Bdc-4182
Gastroesophageal Adenocarcinoma, Gastric Cancer Adenocarcinoma Metastatic
Phase I/II
Recruiting
A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer
Apr 04, 2025
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Pertuzumab, Bdc-1001
Metastatic Breast Cancer, Her2-Positive Breast Cancer
Phase II
Terminated
Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer
Jun 23, 2023
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Nivolumab, Bdc-1001
Her2-Positive Breast Cancer, Her2-Positive Solid Tumors, Her2-Positive Colorectal Cancer, Her2-Positive Gastroesophageal Cancer, Her2-Positive Endometrial Cancer
Phase I/II
Terminated
A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
Feb 12, 2020
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Bolt Biotherapeutics (BOLT) have in its pipeline
BOLT is currently developing the following drugs: Bdc-4182, Pertuzumab, Bdc-1001, Nivolumab, Bdc-1001. These drug candidates are in various stages of clinical development as the company works toward FDA approval.