Colorectal Cancer (CRC)NCT06751524
Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval
A study testing Botensilimab and Balstililmab in people with Colorectal Cancer (CRC) and Pancreatic Cancer, run by Agenus Inc..
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer (CRC), Pancreatic Cancer, Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- Botensilimab and Balstililmab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
Requests for expanded access use must be initiated by a treating physician. Physicians should contact: contact
About this study
Official title: Botensilimab and Balstilimab Expanded Access Program
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.
- Conditions
- Colorectal Cancer (CRC), Pancreatic Cancer, Non-Small Cell Lung Cancer (NSCLC), Hepatocellular Carcinoma (HCC), Melanoma, Sarcoma
- Being tested
- Botensilimab, Balstililmab
- Keywords
- Compassionate Use, Early Access, Expanded Access, Managed Access, Pre-approval Access, Special Access, Named Patient Program (NPP)
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Hepatocellular, Melanoma, Sarcoma, Ovarian Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotensilimabDrug
Also called AGEN 1181
Administered via an intravenous (IV) infusion of Botensilimab + Balstilimab combination (BOT+BAL).
BalstililmabDrug
Also called AGEN 2034
Administered via an IV infusion of Botensilimab + Balstilimab combination (BOT+BAL).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Agenus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Agenus Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751524
- Sponsor's protocol ID
- BOTBAL EAP
- Status last verified
- May 2026
- First submitted
- 20 Dec 2024
- Last updated
- 15 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botensilimab and Balstilimab Expanded Access Program
- ClinicalTrials.gov ID
- NCT06751524
- Acronym / sponsor ID
- BOTBAL EAP
- Conditions
- Colorectal Cancer (CRC), Pancreatic Cancer, Non-Small Cell Lung Cancer (NSCLC), Hepatocellular Carcinoma (HCC), Melanoma, Sarcoma
- Keywords
- Compassionate Use, Early Access, Expanded Access, Managed Access, Pre-approval Access, Special Access, Named Patient Program (NPP)
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Agenus Inc.Industry (pharma, biotech, devices)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
This EAP is available for indications where there is reasonable scientific basis for use. Availability will depend on territory eligibility.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BotensilimabAlso: AGEN 1181Administered via an intravenous (IV) infusion of Botensilimab + Balstilimab combination (BOT+BAL). | Drug | – |
| BalstililmabAlso: AGEN 2034Administered via an IV infusion of Botensilimab + Balstilimab combination (BOT+BAL). | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Agenus Medical AffairsLink provided by the sponsor.
- Agenus Clinical TrialsLink provided by the sponsor.
- Agenus Access to Investigational Medicines PolicyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Requests for expanded access use must be initiated by a treating physician. Physicians should contact: contact
Medical Director study director
Agenus Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Botensilimab and Balstililmab in people with Colorectal Cancer (CRC) and Pancreatic Cancer, run by Agenus Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Requests for expanded access use must be initiated by a treating physician. Physicians should contact: (+1-781-202-1614, med.info@agenusbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.