drugset
Drugs / BA3021
last change Dec 2025 re-read 9 days ago

BA3021

also known as Ozuriftamab Vedotin

targets ROR2

Developed for
head and neck squamous cell carcinoma · metastatic malignant neoplasm · ovarian cancer
Investigated by
BioAtla, Inc. · AstraZeneca · Canadian Cancer Trials Group · Cancer Research Institute, New York City

Trials 2

today NCT05271604 · Ph 2 NCT04918186 · Ph 2
20232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT05271604 Dec 2022 → Sep 2025 head and neck squamous cell carcinoma, metastatic malignant neoplasm BioAtla, Inc. Completed No outcome recorded
Phase 2 NCT04918186 May 2022 → Dec 2026 expected ovarian cancer Canadian Cancer Trials Group Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2025-09-08 BioAtla, Inc. Regulatory BioAtla Announces Regulatory Update on Clinical Development Plan for Ozuriftamab Vedotin in Oropharyngeal Squamous Cell Carcinoma (OPSCC) Following Productive Type B (End of Phase 2) Meeting with FDA bioatla.com ↗
FDA alignment on Phase 3 ozuriftamab vedotin (Oz-V) trial design, including dosing regimen and endpoints to support potential accelerated approval
2025-06-02 BioAtla, Inc. Results BioAtla Presents Phase 2 Ozuriftamab Vedotin (Oz-V) Clinical Trial Data Demonstrating Compelling Antitumor Activity in HPV-Associated Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC) at the 1.8 mg/kg Q2W dosing regimen bioatla.com ↗
45% overall response rate (ORR) and a 100% disease control rate (DCR) in HPV+ OPSCC patients treated with a median of 3 prior lines of therapy
2024-09-16 BioAtla, Inc. Results BioAtla Presented Phase 2 Ozuriftamab Vedotin Clinical Trial Data Demonstrating Meaningful Antitumor Activity with Manageable Tolerability among Heavily Pretreated Patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting bioatla.com ↗
The poster presentation entitled, “Phase 2 trial of ozuriftamab vedotin (BA3021), a conditionally active biologic (CAB)-ROR2-ADC, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck,” reported multiple confirmed responses among heavily pretreated patients who tolerated treatment well.
2024-07-23 BioAtla, Inc. Regulatory BioAtla Granted FDA Fast Track Designation for Ozuriftamab Vedotin (CAB-ROR2-ADC) for Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck bioatla.com ↗
2018-04-16 BioAtla, Inc. Regulatory BioAtla Announces FDA Clearance of Investigational New Drug Application For CAB-ROR2-ADC Therapeutic bioatla.com ↗

All press releases naming this drug 9 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as BA3021 “A Phase 2 Open-Label Study of Ozuriftamab Vedotin (BA3021) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck” NCT05271604 ↗
1

NCT04918186 ↗
Known as Ozuriftamab Vedotin ClinicalTrials.gov intervention name — accepted as the source's own label NCT05271604 ↗
Target ROR2 “Conditionally active biologic anti-ROR2 antibody drug conjugate” NCT05271604 ↗