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

Agenus

Status

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

Treatments: Drug: Botensilimab; Drug: Balstililmab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT06751524

BOTBAL EAP

Details and patient eligibility

About

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.

Full description

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

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.