Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
9-ING-41 · 2 trials · 29 indications
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Measured with RECIST v 1.1
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 |
|---|---|---|
| 9-ING-41 + carboplatin | EXPERIMENTAL | Participants will be divided into 2 cohorts: Salivary Gland Cancer with adenoid cystic carcinoma (ACC) and Salivary Gland Cancer without adenoid cystic carcinoma (ACC) and receive: * 9-ING-41 2x every 21 day study cycle on Day 1 and Day 4 up to 1 year with option to continue beyond if participant is showing benefit * Carboplatin 1x every 21 day study cycle on Day 1 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 |
| 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 |