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The Seven Trial: Exploiting the Unfolded Protein Response

NCT06076837 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-01-12

No results posted yet for this study

Summary

The goal of this investigator initiated interventional study is to improve the response to the anticancer treatments (chemotherapy) in people who have previously untreated metastatic pancreas cancer. The main question it aims to answer is:

• Do new types of immune-based therapies, called botensilimab, and balstilimab, when given in combination with chemotherapy consisting of nab-paclitaxel + gemcitabine + cisplatin, and oral medications of chloroquine and celecoxib help patients with previously untreated metastatic pancreatic cancer?

Participants will be administered two immune-based therapies:

* Botensilimab (also referred to as AGEN1811)
* Balstilimab (also referred to as AGEN2034)

Patients will be evaluated when given in combination with:

* Triple chemotherapy (nab-paclitaxel + gemcitabine + cisplatin), plus two oral medications:
* chloroquine
* celecoxib

Conditions

  • Pancreatic Cancer Metastatic
  • Pancreatic Adenocarcinoma Metastatic

Interventions

DRUG

Botensilimab

an Fc-engineered anti-CTLA-4 (cytotoxic T-lymphocyte antigen 4) monoclonal antibody

DRUG

Balstilimab

a human monoclonal immunoglobulin (Ig) G4 (IgG4) antibody, designed to block programmed cell death protein (PD-1) binding by PD-L1 and PD-L2

DRUG

Chloroquine Phosphate

an antimalarial agent, that is being used in this patient population to sensitize cancer cells to chemotherapy and leads to anticancer effects through inhibiting autophagy

DRUG

Celecoxib

a second-generation selective Cyclooxygenase 2 (COX-2) inhibitor, is being used in this patient population to enhance the therapeutic effect of cisplatin by inhibiting the expression of COX-2 as well as inhibit anti-apoptotic gene BCL-2 (B-cell lymphoma 2)

DRUG

Nab paclitaxel

microtubule inhibitor indicated for the treatment of Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine

DRUG

Gemcitabine

a nucleoside metabolic inhibitor indicated as a single agent for the treatment of pancreatic cancer

DRUG

Cisplatin

platinum-based drug indicated for the treatment of advanced cancers

Sponsors & Collaborators

  • University of Arizona

    collaborator OTHER

  • Agenus Inc.

    collaborator INDUSTRY

  • HonorHealth Research Institute

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-09
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06076837 on ClinicalTrials.gov