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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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

Conditions

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

Keywords

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Compassionate Use Early Access Expanded Access Managed Access Pre-approval Access Special Access Named Patient Program (NPP)

Interventions

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Botensilimab

Administered via an intravenous (IV) infusion of Botensilimab + Balstilimab combination (BOT+BAL).

Intervention Type DRUG

Balstililmab

Administered via an IV infusion of Botensilimab + Balstilimab combination (BOT+BAL).

Intervention Type DRUG

Other Intervention Names

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AGEN 1181 AGEN 2034

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Agenus Inc.

Central Contacts

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

Role: CONTACT

Phone: +1-781-202-1614

Email: [email protected]

Other Identifiers

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BOTBAL EAP

Identifier Type: -

Identifier Source: org_study_id