ClinicalTrials.gg
AvailableNCT06751524Updated May 15, 2026

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

An expanded access record providing Botensilimab and Balstililmab in Colorectal Cancer (CRC), Pancreatic Cancer and Non-Small Cell Lung Cancer (NSCLC), sponsored by Agenus Inc.. Available. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Agenus Inc. · Expanded access

Study type
Expanded access
Access type
Individual patients
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • 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)
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In context

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

Browse Colorectal Neoplasms studies →

Lead sponsor

Agenus Inc. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 3 (27%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All

Eligibility 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 .
  • 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 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

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

    Also known as: AGEN 1181

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

    Also known as: AGEN 2034

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Where to request access

No study locations are listed for this record.

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References and documents

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06751524
Lead sponsor
Agenus Inc.
Responsible party
Sponsor
First posted
Dec 30, 2024
Last update
May 15, 2026

Study contacts

Requests for expanded access use must be initiated by a treating physician. Physicians should contact:
Contact
med.info@agenusbio.com
+1-781-202-1614
Medical Director
study director · Agenus Inc.
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

Contact the provider

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Discussion

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