Drugs / TRASTUZUMAB PAMIRTECAN
TRASTUZUMAB PAMIRTECAN
Trials 5 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06827236 | Apr 2025 → Aug 2029 expected | breast carcinoma | BioNTech SE | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05150691 | Jan 2022 → Apr 2026 overdue | — | DualityBio Inc. | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06340568 | Jun 2025 → Mar 2028 expected | endometrial cancer | BioNTech SE | Recruiting | No outcome recorded |
| Phase 3 | NCT06265428 | Jan 2024 → Feb 2026 overdue | HER2 positive breast carcinoma | DualityBio Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06018337 | Jan 2024 → Jun 2026 overdue | breast cancer | DualityBio Inc. | Active not recruiting | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-04-11 | BioNTech SE | BioNTech and DualityBio’s Antibody-Drug Conjugate Trastuzumab Pamirtecan Demonstrated Clinically Meaningful Efficacy in Patients with HER2-Expressing, Recurrent Endometrial Cancer biontech.com ↗ |
| 2025-09-05 | BioNTech SE | BioNTech and DualityBio Announce Phase 3 Trial of ADC Candidate BNT323/DB-1303 Met Primary Endpoint of Progression Free Survival in HER2-Positive Metastatic or Unresectable Breast Cancer biontech.com ↗ |
| 2024-01-22 | BioNTech SE | BioNTech and DualityBio Initiate Pivotal Phase 3 Trial Of Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Metastatic Breast Cancer biontech.com ↗ |
| 2023-12-21 | BioNTech SE | BioNTech and DualityBio Receive FDA Breakthrough Therapy Designation for Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Endometrial Cancer biontech.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TRASTUZUMAB PAMIRTECAN | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068309 ↗ |
| Known as | BNT323 | “This study is designed to compare efficacy and safety of DB-1303/BNT323 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated...” NCT06265428 ↗3“receive a 8 mg/kg IV dose of DB-1303/BNT323 on Day 1 of each cycle Q3W” NCT06018337 ↗ |
| Known as | DB-1303 | “BNT323 (also known as DB-1303) or chemotherapy” NCT06340568 ↗ |
| Known as | DB-1303/BNT323 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05150691 ↗ |
| Route | Intravenous | “Administered IV” NCT05150691 ↗ |