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

NCT06751524 | Unknown

• 1 other identifier: BOTBAL EAP
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Interventions

Botensilimab DRUG

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

Also known as: AGEN 1181

Balstililmab DRUG

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

Also known as: AGEN 2034

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Agenus Inc.: lead

Related Links

• Agenus Medical Affairs
• Agenus Clinical Trials
• Agenus Access to Investigational Medicines Policy

MeSH Terms

Conditions

Colorectal Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Hepatocellular; Melanoma; Sarcoma; Ovarian Neoplasms; Prostatic Neoplasms

Interventions

balstilimab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Connective and Soft Tissue; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Agenus Inc.

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

+1-781-202-1614; med.info@agenusbio.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12