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Antibody-drug conjugate

CAB-ROR2-ADC + PD-1 Inhibitor for Breast Cancer

Phase 1 & 2
Recruiting
Research Sponsored by BioAtla, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate hematological function
Adequate liver function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Who is the study for?
This trial is for adults with advanced cancers like TNBC, head & neck cancer, NSCLC or melanoma that can't be removed by surgery or have spread and don't respond to standard treatments. Participants must have a life expectancy of at least three months, measurable disease, good performance status (able to carry out daily activities), and proper organ function.Check my eligibility
What is being tested?
The study tests CAB-ROR2-ADC's safety and effectiveness in solid tumors. It includes patients who've exhausted all treatment options. The trial has two phases: the first checks dosage levels; the second expands testing to specific cancers like lung cancer and melanoma alongside a PD-1 inhibitor.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions similar to allergic responses during drug administration, fatigue, digestive issues including nausea or diarrhea, blood disorders affecting cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood counts are within a healthy range.
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My liver is working well.
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I am 18 years old or older.
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My kidneys are working well.
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I have advanced lung, breast, or soft tissue cancer that cannot be surgically removed.
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My advanced cancer has not responded to standard treatments, and no curative options are available to me.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1 and 2: Safety Profile
Phase 1: Safety Profile
Phase 2: Confirmed Objective Response Rate (ORR)
Secondary outcome measures
Phase 1 and 2: Best overall response (OR)
Phase 1 and 2: Disease control rate (DCR)
Phase 1 and 2: Duration of response (DOR)
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Monotherapy - CAB-ROR2-ADC (BA3021) aloneExperimental Treatment1 Intervention
BA3021 alone Q2W dosing regimen
Group II: Combination TherapyExperimental Treatment2 Interventions
CAB-ROR2-ADC (BA3021) with PD-1 inhibitor

Find a Location

Who is running the clinical trial?

BioAtla, Inc.Lead Sponsor
6 Previous Clinical Trials
988 Total Patients Enrolled
1 Trials studying Melanoma
320 Patients Enrolled for Melanoma
Eric SieversStudy ChairBioAtla, Inc.
Philippe MartinStudy DirectorBioAtla, Inc.

Media Library

CAB-ROR2-ADC (Antibody-drug conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03504488 — Phase 1 & 2
Melanoma Research Study Groups: Monotherapy - CAB-ROR2-ADC (BA3021) alone, Combination Therapy
Melanoma Clinical Trial 2023: CAB-ROR2-ADC Highlights & Side Effects. Trial Name: NCT03504488 — Phase 1 & 2
CAB-ROR2-ADC (Antibody-drug conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03504488 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this research study still open to the public?

"Per the data on clinicaltrials.gov, this investigation is actively recruiting participants. It was initially posted in June of 2018 and updated as recently as July 2022."

Answered by AI

What is the ultimate goal of this experiment?

"The primary aim of the trial, which will be evaluated over a period of three weeks, is to identify the Maximum Tolerated Dose (MTD). Secondary endpoints focus on pharmacokinetics and include Cmax (maximum observed concentration), immunogenicity of BA3021 through anti-drug antibody detection, and AUC (area under the concentration versus time curve)."

Answered by AI

How many facilities are participating in this trial's implementation?

"Currently, 36 different medical facilities are recruiting participants for this trial. In addition to Buffalo, Cincinnati and Los Angeles, there are 33 other possible sites you may visit in order to participate. To reduce travel expenses it is ideal that you select the closest site near your residence."

Answered by AI

How many participants are being enrolled for this research?

"In order to bring this clinical trial to fruition, BioAtla Inc. must recruit 420 eligible patients from sites such as Roswell Park in Buffalo and The Christ Hospital in Cincinnati."

Answered by AI
~103 spots leftby Dec 2025