Study of Ozuriftamab Vedotin (BA3021) Alone and in Combination with Nivolumab in Patients with Advanced Solid Tumors

A Phase 1/2 Dose Escalation and Dose Expansion Study of Ozuriftamab Vedotin (BA3021) Alone and in Combination with Nivolumab in Patients with Advanced Solid Tumors

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000137-17-ES

Enrollment

134

Registered

2022-06-22

Start date

2022-09-27

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced solid tumors MedDRA version: 21.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: Ozuriftamab Vedotin Product Code: BA3021 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: NA CAS Number: 2460399-44-2 Current Sponsor code: BA30

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients must: - Have histologically or cytologically confirmed locally advanced unresectable or metastatic NSCLC or melanoma; - Age = 18 Year; - Adequate renal function - Adequate liver function; - Adequate hematological function; - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Life expectancy of at least three months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 41 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 93

Exclusion criteria

Exclusion criteria: - Clinically significant cardiac disease; - Known non-controlled central nervous system (CNS) metastasis; - Prior therapy with a conjugated or unconjugated auristatin derivative / vinca-binding site targeting payload; - A history of = Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study. - Major surgery within 4 weeks before first BA3011 administration; - Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); - Women who are pregnant or breast feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary: • To assess antitumor activity of BA3021 alone and in combination with nivolumab. • To assess the safety of BA3021 alone and in combination with nivolumab.;Secondary Objective: Secondary: • To further characterize the clinical activity of BA3021 alone and in combination with nivolumab. Exploratory: • To assess the PK of BA3021 alone and in combination with nivolumab. • To evaluate the immunogenicity of BA3021 alone and in combination with nivolumab. • To explore the relationship between tumor receptor tyrosine kinase orphan receptor 2 (ROR2) status and clinical response to BA3021. • To evaluate potential candidate tumor and blood-based biomarkers for patient selection or correlation with antitumor activity of BA3021.;Primary end point(s): • Efficacy: ORR. • Safety: AEs, SAEs, and changes from baseline in laboratory parameters and vital signs.;Timepoint(s) of evaluation of this end point: Objective response rate (ORR) is defined as the proportion of subjects with a best overall response of confirmed CR or confirmed PR that occur prior to the initiation of subsequent anticancer treatment.	—

Measure

Time frame

Main Objective: Primary: • To assess antitumor activity of BA3021 alone and in combination with nivolumab. • To assess the safety of BA3021 alone and in combination with nivolumab.;Secondary Objective: Secondary: • To further characterize the clinical activity of BA3021 alone and in combination with nivolumab. Exploratory: • To assess the PK of BA3021 alone and in combination with nivolumab. • To evaluate the immunogenicity of BA3021 alone and in combination with nivolumab. • To explore the relationship between tumor receptor tyrosine kinase orphan receptor 2 (ROR2) status and clinical response to BA3021. • To evaluate potential candidate tumor and blood-based biomarkers for patient selection or correlation with antitumor activity of BA3021.;Primary end point(s): • Efficacy: ORR. • Safety: AEs, SAEs, and changes from baseline in laboratory parameters and vital signs.;Timepoint(s) of evaluation of this end point: Objective response rate (ORR) is defined as the proportion of subjects with a best overall response of confirmed CR or confirmed PR that occur prior to the initiation of subsequent anticancer treatment.

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Secondary

Measure	Time frame
Secondary end point(s): Efficacy: o DOR o Duration of response (DOR) o Progression-free survival (PFS) o Best overall response (BOR) o Disease control rate (DCR) o Time to response (TTR) o Overall survival (OS) o Percent change from baseline in tumor size;Timepoint(s) of evaluation of this end point: DOR is defined as the time from the first documented OR until the first documented disease progression or death, whichever occurs first. PFS is defined as the time from the first dose of IP until the first documentation of disease progression or death. BOR will be based on all post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy. DCR is defined as the proportion of pts with a best overall response of confirmed CR, confirmed PR, or stable disease (SD)=12 weeks. Duration of SD is defined as the time from the first dose of IP until the first documentation of disease progression or death. TTR is defined as the time from the first dose of IP until the first documentation of OR. OS is defined as the time from the first dose of BA3021 until death.	—

Measure

Time frame

Secondary end point(s): Efficacy: o DOR o Duration of response (DOR) o Progression-free survival (PFS) o Best overall response (BOR) o Disease control rate (DCR) o Time to response (TTR) o Overall survival (OS) o Percent change from baseline in tumor size;Timepoint(s) of evaluation of this end point: DOR is defined as the time from the first documented OR until the first documented disease progression or death, whichever occurs first. PFS is defined as the time from the first dose of IP until the first documentation of disease progression or death. BOR will be based on all post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy. DCR is defined as the proportion of pts with a best overall response of confirmed CR, confirmed PR, or stable disease (SD)=12 weeks. Duration of SD is defined as the time from the first dose of IP until the first documentation of disease progression or death. TTR is defined as the time from the first dose of IP until the first documentation of OR. OS is defined as the time from the first dose of BA3021 until death.

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Countries

France, Germany, Greece, Hong Kong, Italy, Poland, Spain, Taiwan, United States

Contacts

Public ContactJi Hwan Lee

BioAtla Inc.

Clinicaltrials@bioatla.com+18585580708

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026