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Antibody-drug conjugate

CAB-AXL-ADC + PD-1 Inhibitor for Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by BioAtla, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Age ≥ 18 years
Must not have
Patients must not have known non-controlled CNS metastasis.
Patients must not have 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it is safe and effective for patients with non-small cell lung cancer.

Who is the study for?
Adults over 18 with non-small cell lung cancer (NSCLC) who have measurable disease, are in good physical condition (ECOG status of 0 or 1), and expected to live at least three months. They must have proper blood, kidney, and liver function. Those with severe heart issues, prior specific cancer treatments, recent major surgery, uncontrolled brain metastasis, certain allergies or infections like HIV/hepatitis are excluded.
What is being tested?
The trial is testing the safety and effectiveness of a new drug called CAB-AXL-ADC for NSCLC patients. It's being compared against PD-1 inhibitors which are a type of immunotherapy that helps the immune system fight cancer cells.
What are the potential side effects?
Possible side effects include allergic reactions related to monoclonal antibody therapy; however specific side effects for CAB-AXL-ADC aren't listed but may be similar to other chemotherapy drugs such as fatigue, nausea, low blood counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have uncontrolled brain metastases.
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I have never had a severe allergic reaction to antibody treatments.
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I am not pregnant or breastfeeding.
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I have never been treated with auristatin or similar cancer drugs.
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I do not have any serious heart conditions.
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I have not had major surgery in the last 4 weeks.
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I do not have HIV, active hepatitis B, or hepatitis C.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Confirmed Objective Response Rate (ORR) per RECIST v1.1
Incidence of Adverse Events (AEs)or Serious Adverse Events (SAEs) as assessed by CTCAE v4.03/v5
Secondary study objectives
Best overall response (BOR)
Disease control rate (DCR)
Duration of response (DOR)
+3 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: CAB-AXL-ADC (BA3011)+PD-1 inhibitorExperimental Treatment2 Interventions
CAB-AXL-ADC (BA3011) with PD-1 inhibitor
Group II: CAB-AXL-ADC (BA3011)Experimental Treatment1 Intervention
CAB-AXL-ADC (BA3011) alone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PD-1 inhibitor
2022
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

BioAtla, Inc.Lead Sponsor
6 Previous Clinical Trials
1,558 Total Patients Enrolled

Media Library

CAB-AXL-ADC (Antibody-drug conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT04681131 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: CAB-AXL-ADC (BA3011)+PD-1 inhibitor, CAB-AXL-ADC (BA3011)
Non-Small Cell Lung Cancer Clinical Trial 2023: CAB-AXL-ADC Highlights & Side Effects. Trial Name: NCT04681131 — Phase 2
CAB-AXL-ADC (Antibody-drug conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04681131 — Phase 2
~37 spots leftby Aug 2025
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