The Seven Trial: Exploiting the Unfolded Protein Response

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
HonorHealth Research Institute
Study ID
NCT06076837
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Pancreatic Adenocarcinoma Metastatic
  • Pancreatic Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Botensilimab — DRUG
    an Fc-engineered anti-CTLA-4 (cytotoxic T-lymphocyte antigen 4) monoclonal antibody
  • Balstilimab — DRUG
    a human monoclonal immunoglobulin (Ig) G4 (IgG4) antibody, designed to block programmed cell death protein (PD-1) binding by PD-L1 and PD-L2
  • Chloroquine Phosphate — DRUG
    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
  • Celecoxib — DRUG
    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)
  • Nab paclitaxel — DRUG
    microtubule inhibitor indicated for the treatment of Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine
  • Gemcitabine — DRUG
    a nucleoside metabolic inhibitor indicated as a single agent for the treatment of pancreatic cancer
  • Cisplatin — DRUG
    platinum-based drug indicated for the treatment of advanced cancers

Study Details

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

Key Dates

Start date
Jan 9, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: DoseEscalationBotensilimab+balstilimab+nab-paclitaxel+gemcitabine+cisplatin +chloroquine + celecoxib
    Botensilimab 50 mg IV, Balstilimab 240 mg, nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2 +cisplatin 25 mg/m2; Chloroquine phosphate 500 mg po (300 mg equivalent chloroquine base); Celecoxib 200 mg po twice daily (BID) on Famotidine 20 mg po BID Aspirin 81 mg
  • Experimental: Expansion Cohort-Botensilimab+balstilimab+nab-paclitaxel+gemcitabine+cisplatin+chloroquine+celecoxib
    Botensilimab (MTD TBD), Balstilimab 240 mg IV, nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2 +cisplatin 25 mg/m2 IV infusion ; Chloroquine phosphate 500 mg po (300 mg equivalent chloroquine base),Celecoxib 200 mg po twice daily (BID); Famotidine 20 mg po BID Aspirin 81 mg

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Trials Nurse NavigatorScottsdaleArizona85258-

Find similar trials in Scottsdale, AZ

By research site
Clinical Trials Nurse Navigator· Scottsdale, AZ

Related Studies