Program to Access Botensilimab and Balstilimab Before Official Approval

Sponsor: Agenus Inc.

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06751524

Provider View

This program allows patients to access the investigational drugs Botensilimab and Balstilimab before they are officially approved by health authorities. A doctor will decide if the potential benefits of these drugs outweigh the risks for each patient.

Patient Parameters

Program Overview

This program is designed to provide access to Botensilimab and Balstilimab for patients who need them before they are officially approved. A doctor will evaluate if the benefits of using these investigational drugs are greater than the risks, based on the patient's medical history and eligibility for the program.

Description

This program is available for conditions where there is scientific support for using these drugs. Whether the drugs are available will depend on the rules in different areas.

Eligibility Criteria

Inclusion Criteria

  • The patient has a serious or life-threatening disease.
  • The patient has tried standard treatments, and there are no other satisfactory treatment options available.
  • The treatment can be used alongside an existing treatment and is not medically inappropriate.
  • There is enough evidence to show that the potential benefits of the treatment outweigh the risks.
  • There is enough clinical data to determine the right dose and treatment duration.
  • The patient's doctor and medical experts at Agenus agree that the potential benefits justify the risks.
  • The patient cannot join an ongoing clinical trial for the investigational medicine, possibly due to location.
  • The program will not negatively affect any ongoing clinical trials needed for official approval.
  • The request for access must be made by the patient's doctor.

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