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

Sponsor: Agenus Inc.

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06751524

Patient View

This EAP provides access to Botensilimab and Balstilimab for serious or life-threatening conditions lacking satisfactory treatments. Eligibility requires prior standard treatment attempts, a favorable benefit-risk assessment, and unavailability for clinical trials. The intervention involves IV infusion of the BOT+BAL combination. Requests must be physician-initiated, ensuring no impact on pivotal trials.

Patient Parameters

Program Overview

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.

Description

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

Eligibility Criteria

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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