Expanded Access Program (EAP) Designed To Provide Access To Botensilimab And Balstilimab Before Regulatory Approval

Study Overview

Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval

This is an expanded access program (EAP) designed to provide access to Botensilimab and Balstilimab prior to drug registration by the applicable local regulatory agency. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

This EAP is available for indications where there is reasonable scientific basis for use. Availability will depend on territory eligibility.

Colorectal Cancer (CRC)
Pancreatic Cancer
Non-Small Cell Lung Cancer (NSCLC)
Hepatocellular Carcinoma (HCC)
Melanoma
Sarcoma
Ovarian Cancer
Prostate Cancer

DRUG: Botensilimab
DRUG: Balstililmab

BOTBAL EAP

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-12-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-12-20
First Submitted that Met QC Criteria 2024-12-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-12-30
First Posted (ACTUAL) 2024-12-30	Results First Posted N/A	Last Verified 2024-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Requests for expanded access use must be initiated by a treating physician. Physicians should contact:

Phone Number: +1-781-202-1614

Email: med.info@agenusbio.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

The patient's disease is serious or life-threatening.
The patient has undergone appropriate standard treatments; there are no comparable or satisfactory alternative treatments for the disease or condition; the treatment is adjunct to an existing treatment option, and the treatment is not medically contra-indicated.
Sufficient efficacy and safety evidence exists to make a benefit-risk analysis consistent with this policy and the potential patient benefit justifies any potential risks of treatment.
Sufficient clinical data are available to identify an appropriate dose and treatment duration.
The patient's treating physician and qualified medical personnel at Agenus agree there is sufficient evidence to assume the potential benefit to the patient justifies potential risks.
The patient is not eligible for participation in an ongoing clinical trial of the investigational medicine, including lack of access due to geographic limitations.
Expanded Access will not adversely impact any clinical development program, in particular, the conduct of a pivotal clinical trial that is required for regulatory approval.
The request must be made by the patient's treating physician.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Medical Director, Agenus Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record