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

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

• Registration Number: NCT06751524
• Lead Sponsor: Agenus Inc.

Brief Summary

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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-30
• Last Update Posted: 2024-12-30

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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.

Note: Other defined Inclusion/Exclusion criteria may apply.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified