Drugs / TRASTUZUMAB IMBOTOLIMOD
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04278144 | Feb 2020 → Dec 2024 | HER2 positive breast carcinoma, gastroesophageal cancer | Bolt Biotherapeutics, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 21 trial | ||||||
| Phase 2 | NCT05954143 | Nov 2023 → Sep 2024 | HER2 positive breast carcinoma | Bolt Biotherapeutics, Inc. | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2024-11-07 | Bolt Biotherapeutics, Inc. | Results Bolt Biotherapeutics Presents Updated Preclinical Data for BDC-4182 and Key Learnings from Phase 1 Dose-Escalation Trial of BDC-1001 at SITC 39th Annual Meeting boltbio.com ↗
Our key learnings from the Phase 1 BDC-1001 dose escalation trial that are being presented at SITC support our belief that next-generation Boltbody™ ISACs with enhanced immune activation will offer greater efficacy with the potential for durable responses. |
| 2023-10-23 | Bolt Biotherapeutics, Inc. | Results Bolt Biotherapeutics Presents Updated Clinical Data from Phase 1 Dose-Escalation Trial of BDC-1001 as Monotherapy and in Combination with Nivolumab in HER2-Expressing Tumors at ESMO 2023 Congress boltbio.com ↗
today presented updated data from its Phase 1 dose-escalation trial of BDC-1001 at the European Society for Medical Oncology (ESMO) 2023 Congress, being held in Madrid, Spain and virtually from October 20-24, 2023. |
| 2023-09-28 | Bolt Biotherapeutics, Inc. | Regulatory Bolt Biotherapeutics Receives Orphan Drug Designation for BDC-1001 for Treatment of Gastric Cancers boltbio.com ↗
Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for BDC-1001 for the treatment of gastric cancer, including gastroesophageal junction cancer. |
| 2023-05-25 | Bolt Biotherapeutics, Inc. | Results Bolt Biotherapeutics Highlights Comprehensive Clinical Data from Phase 1 Dose-Escalation Trial of BDC-1001 as Monotherapy and in Combination with Nivolumab in HER2-Expressing Tumors at 2023 ASCO Annual Meeting boltbio.com ↗ |
| 2023-03-29 | Bolt Biotherapeutics, Inc. | Results Bolt Biotherapeutics Announces Positive Topline Data from BDC-1001 Phase 1 Dose-Escalation Trial in HER2-Expressing Tumors, Supporting Advancement to Phase 2 Clinical Studies boltbio.com ↗
Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company pioneering novel immuno-oncology therapeutics for the treatment of cancer, today reported positive topline data from the company’s recently completed dose-escalation study of BDC-1001 in HER2-expressing solid tumors that support advancing into two Phase 2 studies. |
| 2021-12-06 | Bolt Biotherapeutics, Inc. | Results Bolt Biotherapeutics Reports Interim BDC-1001 Phase 1/2 Data Demonstrating a Safe and Well-tolerated Profile and Emerging Clinical Activity at the ESMO Immuno-Oncology Congress 2021 boltbio.com ↗
BDC-1001 demonstrated a favorable safety and tolerability profile at all evaluated doses and schedules, showing early signs of clinical activity with corresponding biomarker changes in the tumor microenvironment of post-treatment tumor biopsies. |
| 2021-06-04 | Bolt Biotherapeutics, Inc. | Results Bolt Biotherapeutics Presents Preliminary Results from Phase 1/2 Trial of Lead HER2-targeting Boltbody™ ISAC BDC-1001 at ASCO 2021 boltbio.com ↗
Clinical activity was seen in the form of stable disease, reductions in tumor volume including a confirmed partial response and increases in pharmacodynamic markers that Bolt believes are consistent with its proposed mechanism of action. |
| 2021-04-10 | Bolt Biotherapeutics, Inc. | Results Bolt Biotherapeutics Announces AACR 2021 Presentation of Boltbody™ Platform Mechanism of Action and Clinical Properties of Lead ISAC, BDC-1001 boltbio.com ↗
Bolt is utilizing its Boltbody™ platform to create immune-stimulating antibody conjugates (ISACs), such as BDC-1001, that invoke this mechanism and provided complete tumor regression in preclinical tumor models. |
All press releases naming this drug 15 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TRASTUZUMAB IMBOTOLIMOD | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095315 ↗ |
| Known as | BDC-1001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04278144 ↗ |
| Action | Activate | “TLR 7/8 dual agonist” NCT04278144 ↗ |
| Modality | Monoclonal antibody | “Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist” NCT04278144 ↗ |
| Route | Intravenous | “BDC-1001 administered intravenously (IV) every 2 weeks” NCT05954143 ↗ |