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Antibody-drug conjugate

CAB-AXL-ADC + PD-1 Inhibitor for Sarcoma

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
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Age ≥ 12 years (Phase 2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

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 adolescents and adults with various types of sarcoma, including Ewing Sarcoma and Osteosarcoma. Participants need to have a life expectancy of at least three months, be aged 12 or older (for Phase 2), and have good kidney, liver, and blood function. They should also be relatively active (ECOG status of 0 or 1). People who've had certain prior therapies, significant heart disease, uncontrolled brain metastasis, severe allergies to monoclonal antibodies or components used in the study are excluded.Check my eligibility
What is being tested?
The trial is testing CAB-AXL-ADC's safety and effectiveness against solid tumors in patients with sarcoma. It will also involve a PD-1 inhibitor as part of the treatment regimen. The goal is to see how well these interventions work together in treating different kinds of sarcomas.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to the PD-1 inhibitor such as fatigue, skin issues or inflammation inside the body; allergic reactions from monoclonal antibody therapy; plus any risks associated with CAB-AXL-ADC which could affect organ functions.

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 12 years old or older.

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 overall response rate (ORR) per RECIST v1.1
Secondary outcome measures
Phase 1 and 2: Best overall response (BOR)
Phase 1 and 2: Disease control rate (DCR)
Phase 1 and 2: Duration of response (DOR)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Combination TherapyExperimental Treatment2 Interventions
Phase 2: BA3011 in combination with PD-1 inhibitor.
Group II: BA3011Experimental Treatment1 Intervention
Phase 1: All patients will receive BA3011, CAB-AXL-ADC. Phase 2: All patients will receive either BA3011 alone or in combination with PD-1 inhibitor.

Find a Location

Who is running the clinical trial?

BioAtla, Inc.Lead Sponsor
6 Previous Clinical Trials
1,288 Total Patients Enrolled

Media Library

CAB-AXL-ADC (Antibody-drug conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03425279 — Phase 1 & 2
Pleomorphic Sarcoma Research Study Groups: BA3011, Combination Therapy
Pleomorphic Sarcoma Clinical Trial 2023: CAB-AXL-ADC Highlights & Side Effects. Trial Name: NCT03425279 — Phase 1 & 2
CAB-AXL-ADC (Antibody-drug conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03425279 — Phase 1 & 2

Frequently Asked Questions

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

Are there numerous hospitals administering this trial throughout the nation?

"Currently, this trial is taking place in 28 different locations. Some of these sites are situated in Los Angeles, Columbus and Durham; however, there are also 25 other clinical centres running this study. If you enroll, it would be advantageous to choose the nearest location to cut down on travel time."

Answered by AI

How many people are the most that will be taking part in this experiment?

"The sponsor, BioAtla, Inc., needs to recruit 120 eligible patients from clinical trial sites that include Children's Hospital Los Angeles and Nationwide Children's Hospital."

Answered by AI

Are we able to sign new patients up for this clinical trial right now?

"Yes, this study is still recruiting patients. It was originally posted on February 15th, 2018, and the most recent update was on October 5th, 2022."

Answered by AI

What is the main focus of this clinical trial?

"The aim of this 24-month clinical trial is to evaluate BA3011's anti-tumor activity. Additionally, researchers will be looking at the drug's pharmacokinetics (AUC), immunogenicity, and overall survival rate in Phase 1 and 2 patients."

Answered by AI

Who else is applying?

What site did they apply to?
The University of Arizona Cancer Center
USC Norris Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I have tried Doxorubicin, ifosfamide (no effect ) and pazopanib (which slowed the growth until it stopped working).
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
2018. "CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03425279.
~26 spots leftby Dec 2024
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