CAB-ROR2-ADC for Melanoma
Phase-Based Progress Estimates
Effectiveness
Safety
Melanoma+6 More
CAB-ROR2-ADC - BiologicalEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective.
Eligible Conditions
- Melanoma
- Breast Cancer (Triple Negative Breast Cancer (TNBC))
- Non-Small Cell Lung Carcinoma (NSCLC)
- Head and Neck Cancer
Treatment Effectiveness
Study Objectives
7 Primary · 13 Secondary · Reporting Duration: Up to 24 months
Week 3
Dose Limiting Toxicities (DLTs)
Week 3
Maximum Tolerated Dose (MTD)
Up to 24 months
Anti-tumor activity
Frequency and severity of Treatment-Emergent Adverse Events (Safety and Tolerability of BA3021)
Immunogenicity of BA3021
Pharmacokinetics; AUC
Pharmacokinetics; Cmax
Phase 1 and 2: Best overall response (OR)
Phase 1 and 2: Disease control rate (DCR)
Phase 1 and 2: Duration of response (DOR)
Phase 1 and 2: Overall survival (OS)
Phase 1 and 2: Progression-free survival (PFS)
Phase 1 and 2: Safety Profile
Phase 1 and 2: Time to response (TTR)
Phase 1 and 2: Tumor size
Phase 1: Confirmed Objective Response Rate (ORR)
Phase 1: Immunogenicity
Phase 1: Pharmacokinetics
Phase 1: Safety Profile
Phase 2: Confirmed Objective Response Rate (ORR)
Trial Safety
Trial Design
2 Treatment Groups
Monotherapy - CAB-ROR2-ADC (BA3021) alone
1 of 2
Combination Therapy
1 of 2
Experimental Treatment
420 Total Participants · 2 Treatment Groups
Primary Treatment: CAB-ROR2-ADC · No Placebo Group · Phase 1 & 2
Monotherapy - CAB-ROR2-ADC (BA3021) alone
Biological
Experimental Group · 1 Intervention: CAB-ROR2-ADC · Intervention Types: BiologicalCombination TherapyExperimental Group · 2 Interventions: CAB-ROR2-ADC, PD-1 inhibitor · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PD-1 inhibitor
2019
Completed Phase 2
~580
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
Who is running the clinical trial?
BioAtla, Inc.Lead Sponsor
5 Previous Clinical Trials
496 Total Patients Enrolled
2 Trials studying Melanoma
156 Patients Enrolled for Melanoma
Yong BenStudy DirectorBioAtla, Inc.
Philippe MartinStudy DirectorBioAtla, Inc.
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:Patients with locally advanced unresectable or metastatic, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC) and soft tissue sarcoma (STS) are eligible for this study.
You have adequate renal function.
You have an ECOG performance status of 0 or 1.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments