A Phase 2 interventional study of FOLFIRNINOX and Losartan in Pancreatic Adenocarcinoma and Pancreatic Adenocarcinoma Metastatic, sponsored by Colin D. Weekes, M.D., PhD. Active, not recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Colin D. Weekes, M.D., PhD · Phase 2, Interventional, and Treatment
The purpose of this study is to find out if an experimental drug will prevent metastatic pancreatic adenocarcinoma from becoming resistant to standard treatment for the disease.
The names of the study drugs involved in this study are:
FOLFIRINOX (made up of 4 different drugs):
This is a multi-institutional, open label, four-arm, non-comparator Phase 2 study of FOLFIRINOX in combination with 9-ING-41 and losartan for the treatment of adult patients with untreated metastatic pancreatic adenocarcinoma (PAC). This research study will begin with a Safety Run-In phase. The Safety Run-In phase will establish the side effects from the study treatment to its safety before beginning the main part of the study. Once that is complete, the main portion of the study will be a Phase II clinical trial.
The U.S. Food and Drug Administration (FDA) has not approved 9-ING-41 as a treatment for pancreatic adenocarcinoma (PAC). The FDA has not approved Losartan for pancreatic adenocarcinoma (PAC), but it has been approved for other uses. The FDA has approved FOLFIRINOX as a treatment option for pancreatic adenocarcinoma (PAC).
This research study involves giving participants an investigational drug called 9- ING-41 with standard anti-cancer drugs. 9-ING-41 stops an enzyme called GSK- 3β from working in cancer cells. Enzymes are proteins that activate and accelerate chemical reactions. The GSK-3β enzyme helps cancer cells to grow and to become resistant to chemotherapy drugs. This study is trying to see if by stopping the activity of GSK-3β using 9-ING-41, it may be possible for standard of care chemotherapy drugs to regain their effectiveness in treating cancers in participants where they have stopped being effective or are effective in only a minority of participants. FOLFIRINOX is a combination of 4 chemotherapy agents that may help shrink pancreatic adenocarcinoma (PAC) tumors. Losartan is a drug that is used to lower blood pressure. In this setting, Losartan has also been demonstrated to suppress TGF-β function in pancreatic adenocarcinoma. Cytokines are molecules that help cells communicate and play a role in immune response. Suppression of TGF-β function is believed to stop the cancer cells from becoming resistant to chemotherapy. This study will evaluate if blocking of GSK-3β activity using 9-ING-41 and blocking of TGF-β function using Losartan can inhibit cancer cell resistance to FOLFIRINOX chemotherapy.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive treatment during three portions of the study: Complete therapy, Maintenance therapy and Transition to complete therapy. After treatment, participants will be followed for up to 5 years.
It is expected that up to 70 people will take part in this research study.
Actuate Therapeutics, a pharmaceutical company, is supporting this research study by providing the study drug 9-ING-41.
The Lustgarten Foundation is providing funding support for this study through a research grant.
Colin D. Weekes, M.D., PhD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants must have adequate organ and marrow function as defined below:
Creatinine clearance ≥ 30 mL/min (as estimated by Cockcroft Gault Equation)
(140 - age [yrs]) (body wt [kg]) Creatinine clearance for males = ------------ (72) (serum creatinine [mg/dL])
Patients with known history of UGT1A1 gene polymorphism detection are eligible to participate. Sites are required to follow the FDA-approved label guidance for Irinotecan when administrating as part of the FOLFIRINOX regimen.
Exclusion Criteria:
The study will begin with a Safety Run-In phase to establish the side effects from the study treatment to its safety before beginning the main part of the study, six (6) participants will receive 1-2 cycles (each study cycle is 14 days +/- 3 days) of: * FOLFIRINOX * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each study cycle * Irinotecan portion of FOLFIRINOX on Day 1 of each study cycle * Oxaliplatin portion of FOLFIRINOX on Day 1 of each study cycle * Leucovorin portion of FOLFIRINOX on Day 1 of each study cycle The FOLFIRINOX treatment regimen will be given every 14 days +/- 3 days at physician discretion. * Elraglusib on days on days 1, 3, 8, and 11 of every 14-day cycle * Losartan daily of every 14-day cycle.
Drug: FOLFIRNINOX · Drug: Losartan · Drug: 9-ING-41
The study will be conducted in three parts depending on participant disease progression: Complete Therapy, Maintenance Therapy and Complete Therapy Round 2. For initial complete therapy, participants will receive FOLFIRINOX as follows (each study cycle is 14 days +/- 3 days, FOLFIRINOX can be given +/- 3 days): * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each study cycle up to 12 cycles (24 weeks) * Irinotecan portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Oxaliplatin portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Leucovorin portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) For Maintenance therapy, participants will receive FOLFIRINOX as follows: * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each 14 day study cycle until disease progression For Complete Therapy Round 2, participants will repeat initial complete therapy of FOLFIRINOX until further disease progression
Drug: FOLFIRNINOX
The study will be conducted in three parts depending on participant disease progression: Complete Therapy, Maintenance Therapy and Complete Therapy Round 2. For initial complete therapy (each study cycle is 14 days +/- 3 days): * FOLFIRINOX (+/- 3 days) * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each study cycle up to 12 cycles (24 weeks) * Irinotecan portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Oxaliplatin portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Leucovorin portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Losartan daily up to 12 cycles (24 weeks) For Maintenance therapy: * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each 14 day study cycle until disease progression * Losartan daily until disease progression For Complete Therapy Round 2, participants will repeat initial complete therapy of FOLFIRINOX + Losartan until further disease progression
Drug: FOLFIRNINOX · Drug: Losartan
The study conducted in 3 parts depending on disease progression: Complete Therapy, Maintenance Therapy and Complete Therapy Round 2 For initial complete therapy (each study cycle is 14 days +/- 3 days): * FOLFIRINOX (+/- 3 days) * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each study cycle up to 12 cycles (24 weeks) * Irinotecan portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Oxaliplatin portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Leucovorin portion of FOLFIRINOX on Day 1 of each study cycle up to 12 cycles (24 weeks) * Elraglusib on days 1, 3, 8, and 11 of every study cycle up to 12 cycles (24 weeks) For Maintenance therapy: * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each study cycle until disease progression * Elraglusib on days 1, 3, 8, and 11 of every study cycle until disease progression For Complete Therapy Round 2, repeat of initial complete therapy until further disease progression
Drug: FOLFIRNINOX · Drug: 9-ING-41
The study conducted in 3 parts depending on disease progression: Complete Therapy, Maintenance Therapy and Complete Therapy Round 2. For initial complete therapy (each study cycle is 14 days +/- 3 days): * FOLFIRINOX (+/- 3 days) * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each study cycle * Irinotecan portion of FOLFIRINOX on Day 1 of each study cycle * Oxaliplatin portion of FOLFIRINOX on Day 1 of each study cycle * Leucovorin portion of FOLFIRINOX on Day 1 of each study cycle * Elraglusib on days 1, 3, 8, and 11 of every 14-day cycle * Losartan daily For Maintenance therapy: * 5Fluorouracil portion of FOLFIRINOX on Days 1-3 of each 14 day study cycle until disease progression * Elraglusib on days 1, 3, 8, and 11 of every 14-day cycle until disease progression * Losartan daily until disease progression For Complete Therapy Round 2, participants will repeat initial complete therapy of FOLFIRINOX + Elraglusib + Losartan until further disease progression
Drug: FOLFIRNINOX · Drug: Losartan · Drug: 9-ING-41
Combination of 4 different drugs (5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan and Leucovorin) administered by intravenous infusion
Taken Orally
Also known as: Cozaar
Administered by intravenous infusion
Also known as: Elraglusib
Progression-free survival (PFS)
Defined from the date of study entry to the earliest date of progressive disease while receiving complete therapy with FOLFIRINOX-based therapy or death due to any cause. PFS will be censored at the date of last follow-up for patients alive without documented progression. PFS curves will be estimated by the Kaplan-Meier method and compared to historical controls treated with FOLFIRINOX alone using the one-sample log-rank test.
Time frame: Date of study entry to the earliest date of progressive disease up to 30 months
Overall survival (OS)
Defined from the date of study entry to the date of death due to any cause and censored at the date of last follow-up for patients still alive. OS curves will be estimated by the Kaplan-Meier method and compared to historical controls using the one-sample log-rank test.
Time frame: Up to 30 months
Median time of maintenance therapy (mMT):
Defined from the date of starting maintenance 5FU-based therapy to time of objective disease progression.
Time frame: Up to 30 months
Objective Response Rate
Defined as the proportion of patients who have a partial or complete response per RECIST 1.1 criteria
Time frame: Up to 30 months
Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap, Icf
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This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Colin D. Weekes, M.D., PhD