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BA3071 + Nivolumab for 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
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
CLTA-4 blocking-antibody naïve.
Must not have
Patients must not have known non-controlled CNS metastasis.
Patients must not have clinically significant cardiac disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Summary

This trialtests a new drug to see if it is safe and effective at treating solid tumors.

Who is the study for?
This trial is for adults (18+) with various advanced solid tumors who haven't been treated with CLTA-4 blocking antibodies. They must be in good physical condition, have normal blood, liver, and kidney functions, and measurable disease. Pregnant or breastfeeding women, those with recent major surgery, significant heart issues, uncontrolled brain metastases or severe allergies to monoclonal antibodies can't participate.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of BA3071 alone and combined with PD-1 blockers Pembrolizumab or Nivolumab in treating solid tumors. It aims to find out how well these treatments work against different types of cancer.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to the body's defense system being activated by the drugs; this could affect organs like the liver or intestines. Other common side effects from such therapies are fatigue, skin reactions, flu-like symptoms and possible infusion-related reactions.

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 can carry out light work.
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I have never received CTLA-4 blocking-antibody treatment.
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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 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 am not pregnant or breastfeeding.
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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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess dose limiting toxicity as defined in the protocol
Assess maximum tolerated dose as defined in the protocol
Confirmed overall response rate (ORR) per RECIST v1.1
+1 more
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC)
Confirmed best overall response (BOR)
Confirmed overall response rate (ORR)
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Combination TherapyExperimental Treatment3 Interventions
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor
Group II: BA3071Experimental Treatment1 Intervention
Conditionally active biologic (CAB) antibody that binds to CTLA-4
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Nivolumab
FDA approved

Find a Location

Who is running the clinical trial?

BioAtla, Inc.Lead Sponsor
6 Previous Clinical Trials
1,268 Total Patients Enrolled
1 Trials studying Melanoma
420 Patients Enrolled for Melanoma
~57 spots leftby Dec 2024
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