Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
9-ING-41 · 2 trials · 29 indications
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 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
| Arm | Type | Description |
|---|---|---|
| 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 | Drug: 9-ING-41 |
| 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. |
| Name | Type | Description |
|---|---|---|
| 9-ING-41 | DRUG | Intravenous infusion |
| Carboplatin | DRUG | Intravenous infusion |
| Pembrolizumab | DRUG | Intravenous infusion |
| 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 |
Inclusion Criteria: * Participants must have histologically confirmed salivary gland carcinoma (any histologic subtype, including ACC) with evidence of recurrent, metastatic or advanced, unresectable disease. * Willing to provide tumor tissue from a diagnostic biopsy or prior surgery. * Age 18 year...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
9-ING-41 is an investigational small molecule being studied for the treatment of cancer, including advanced cancers and salivary gland cancer. It is currently in Phase 2 clinical development for these oncology indications.
9-ING-41 targets GSK-3β, a protein kinase involved in multiple cellular processes. By inhibiting GSK-3β, the drug is being evaluated for its potential anti-cancer activity in patients with advanced malignancies.
9-ING-41 is being developed by Actuate Therapeutics, Inc., a biopharmaceutical company. Actuate Therapeutics is publicly traded under the ticker symbol ACTU.
9-ING-41 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials are currently active but not recruiting patients.
9-ING-41 is being studied in two Phase 2 trials. NCT03678883 evaluates the drug in patients with advanced cancers, with an enrollment of 350 participants across multiple countries. NCT05010629 studies 9-ING-41 plus carboplatin in salivary gland carcinoma, enrolling 32 patients in the United States.
No alternative names for 9-ING-41 have been disclosed. The drug is referred to solely as 9-ING-41 in clinical trial registrations and development documentation.