Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Elraglusib Oral Tablets, 9-ING-41
Elraglusib · 5 trials · 32 indications
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.
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
The percent of patients with response will be assessed at the protocol specified timepoints according to the Revised IWG-MRT and ELN Response Criteria for MF (2013)
The standard assessments used to assign a score to any affected organ system as per the NCI CTCAE 4.03 will be conduced at each protocol-specified timepoint.
To determine the 1-year survival rate of patients treated on the 9-ING-41 schedule chosen from the run-in stage of the study compared to the control arm
Dose escalation/de-escalation decisions and the MTD will be determined at the end of Cycle 1 (each cycle is 21/28days).
| Arm | Type | Description |
|---|---|---|
| Safety Run-In: FOLFIRINOX + Elraglusib + Losartan | EXPERIMENTAL | 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. |
| FOLFIRNINOX | EXPERIMENTAL | 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 |
| FOLFIRINOX + Losartan | EXPERIMENTAL | 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 |
| FOLFIRINOX + Elraglusib | EXPERIMENTAL | 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 |
| FOLFIRINOX + Elraglusib + Losartan | EXPERIMENTAL | 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 |
| Pembrolizumab + 9-ING-41 + carboplatin (Part II) | EXPERIMENTAL | Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year. |
| 9-ING-41 + carboplatin (Part I) | EXPERIMENTAL | Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year. |
| 9-ING-41 | EXPERIMENTAL | 9-ING-41 is administered by intravenous infusion twice weekly at a dose of 9.3 mg/kg. Cycle duration is 28 days. |
| 9-ING-41 plus Ruxolitinib | EXPERIMENTAL | 9-ING-41 9.3 mg/kg will be administered by intravenous infusion twice weekly for cycle durations of 28 days with Ruxolitinib at doses specified in the protocol as appropriate for patient's platelet count. |
| 9-ING-41 plus Gemcitabine | EXPERIMENTAL | Drugs: Gemcitabine - 21 day cycle. 9-ING-41 |
| 9-ING-41 plus Doxorubicin | EXPERIMENTAL | Drugs: Doxorubicin. 9-ING-41 |
| 9-ING-41 plus Lomustine | EXPERIMENTAL | Drugs: Lomustine. 9-ING-41. |
| 9-ING-41 plus Carboplatin | EXPERIMENTAL | Drugs: Carboplatin. 9-ING-41. |
| 9-ING-41 plus nab paclitaxel Gemcitabine | EXPERIMENTAL | Drugs: Nab-paclitaxel. Gemcitabine - 28 day cycle. 9-ING-41. |
| 9-ING-41 plus Paclitaxel/Carboplatin | EXPERIMENTAL | Drugs: Paclitaxel. Carboplatin. 9-ING-41. |
| 9-ING-41 plus Irinotecan | EXPERIMENTAL | Drugs: Irinotecan. 9-ING-41. |
| Elraglusib Monotherapy Dose escalation/de-escalation | EXPERIMENTAL | Elraglusib 250 mg tablets will be administered once daily with food in 21-day cycles. DG-1: 125mg (Days 1, 3, 5 of a 21 day cycle) DG1: (Starting Dose) 125 mg/QD for 21 days DG2: 250mg/QD for 21 days DG3: 500mg QD for 21 days DG4: 750mg/QD for 21 days, Dosing will continue until MTD or MED is identified. Any higher dose levels which are explored will not exceed 50% increment relative to the prior cohort rounded down to the nearest 250 mg dose (or 125 mg dose if necessary). |
| Name | Type | Description |
|---|---|---|
| FOLFIRNINOX | DRUG | Combination of 4 different drugs (5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan and Leucovorin) administered by intravenous infusion |
| Losartan | DRUG | Taken Orally |
| 9-ING-41 | DRUG | Administered by intravenous infusion |
| Carboplatin | DRUG | Intravenous infusion |
| Pembrolizumab | DRUG | Intravenous infusion |
| Ruxolitinib | DRUG | Ruxolitinib at protocol-specified doses for given platelet count |
| Gemcitabine - 21 day cycle | DRUG | Gemcitabine 1250 mg/m2 as a 30-minute intravenous infusion on Days 1 and 8 of a 21-day cycle |
| Doxorubicin. | DRUG | Doxorubicin 75 mg/m2, intravenous bolus on Day 1 of a 21-day cycle up to a maximum lifetime dose of 550 mg/m2. |
| Lomustine | DRUG | Lomustine 30 mg/m² orally as a single dose, weekly for twelve weeks. |
| Carboplatin. | DRUG | Carboplatin AUC 6 IV over 1 hour on Day 1 of a 21-day cycle. |
| Nab paclitaxel. | DRUG | Nab-paclitaxel 125 mg/m2 intravenously on Days 1, 8 and 15 of a 28-day cycle |
| Paclitaxel. | DRUG | Paclitaxel 175 mg/m2 intravenously over 3 hours on Day 1 of a 21-day cycle. |
| Gemcitabine - 28 day cycle | DRUG | Gemcitabine 1000 mg/m2 intravenously over 30-minutes on Days 1, 8 and 15 of a 28-day cycle |
| Irinotecan | DRUG | Irinotecan 350 mg/m2 intravenously over 90-minutes on Day 1 of a 21-day cycle |
| Elraglusib Oral Tablets | DRUG | Elraglusib Oral Tablet, 250 mg |
Inclusion Criteria: * Histologically confirmed metastatic pancreatic adenocarcinoma without prior therapy for pancreatic adenocarcinoma. * Participants must have measurable disease as defined by RECIST 1.1 * Age ≥18 years. * ECOG performance status ≤1 (Karnofsky ≥ 70%, see Appendix A). * Participan...
Elraglusib is an investigational small molecule drug being developed by Actuate Therapeutics, Inc. for advanced malignant solid tumors. It is an oral tablet formulation and is currently in Phase 1 clinical development. It is not yet approved for any indication.
Elraglusib is being studied for the treatment of advanced malignant solid tumors in adults. Its only listed trial enrolls participants aged 18 years and older with advanced solid tumors. It is investigational and has not been approved for commercial use in this or any other indication.
Elraglusib targets GSK3B, also known as glycogen synthase kinase 3 beta. It acts as an inhibitor of this target. GSK3B inhibition is the mechanism under investigation in the Phase 1 solid tumor program being run by Actuate Therapeutics.
Elraglusib is being developed by Actuate Therapeutics, Inc., which trades under the ticker ACTU. The company is the sponsor of the Phase 1 trial evaluating the drug in adult participants with advanced solid tumors.
Elraglusib is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The single registered trial is a Phase 1 study that is not yet recruiting, with a planned enrollment of 100 participants.
Elraglusib is being evaluated in one registered clinical trial, NCT07714395, titled a study to evaluate preliminary anti-tumor activity of elraglusib in adult participants with advanced solid tumors. The Phase 1 trial has a planned enrollment of 100 and is currently not yet recruiting.
Yes, elraglusib oral tablets is another name for elraglusib. Both refer to the same investigational small molecule GSK3B inhibitor developed by Actuate Therapeutics, Inc. for advanced malignant solid tumors. Searches using either name point to the same Phase 1 asset.