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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study 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.

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

Frequently Asked Questions

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

What are the precedents for this research?

"As of right now, there are 747 ongoing studies for Combination Therapy in 50 different countries. The first study was completed 10 years ago and only involved 127 patients. In the past decade, 249 more trials have been conducted with this therapy."

Answered by AI

How many patients are participating in this trial?

"36 patients that fit the bill are needed for this clinical trial. If you're eligible and interested, you can take part in the study at The Angeles Clinic and Research Institute in Los Angeles, California or Horizon Oncology Research, LLC in Lafayette, Indiana."

Answered by AI

What other studies have used a similar approach of combining two or more treatments?

"H. Lee Moffitt Cancer Center and Research Institute first studied Combination Therapy in 2010. So far, there have been 249 completed trials globally with 747 currently active clinical trials. A large number of these are located in Los Angeles, California."

Answered by AI

What goals does this experiment hope to accomplish?

"The objectives of this medical research, which will take place over 24 months, are to confirm the efficacy of the treatment according to RECIST v1.1 and to measure secondary outcomes including plasma concentration (AUC), survival rates, and response rate."

Answered by AI

In how many different medical practices is this research being conducted presently?

"This trial has 7 active sites, with The Angeles Clinic and Research Institute in Los Angeles, Horizon Oncology Research, LLC in Lafayette, and University of Utah Huntsman Cancer Institute in Salt Lake City being some of the more notable locations."

Answered by AI

How is Combination Therapy classically used to assist patients?

"malignant neoplasms is most often treated with a combination of different therapies. This approach has also been shown to be effective for treating other conditions including unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

Are patients currently being enrolled in this clinical trial?

"This trial, as indicated by its listing on clinicaltrials.gov, is recruiting patients. The posting went up on 8/3/2022 and was edited for the 10/6/2022."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What site did they apply to?
Piedmont West
Horizon Oncology Research, LLC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

Do you pay for travel?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I don't feel I'm getting proper treatment with the doctor I have.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Phase 1/2 Study of BA3071 as Monotherapy and in Combination With a PD-1 Blocking Antibody in Patients With Advanced Solid Tumors
2022. "A Phase 1/2 Study of BA3071 as Monotherapy and in Combination With a PD-1 Blocking Antibody in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05180799.
~91 spots leftby Dec 2024
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