Ide196-001 A Phase 1/2 Study Of Ide196 In Patients With Solid Tumors Harboring Gnaq/11 Mutations Or Prkc Fusions
Posted Date: Jul 6, 2021
- Investigator: Trisha Wise-Draper
- Specialties: Cancer, Oncology
- Type of Study: Drug
The primary purpose of this study is to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors. Efficacy will be measured by Dose-limiting Toxicity, Maximum Tolerated Dose, Recommended Phase 2 Dose (RP2D) as monotherapy, in combination with Binimetinib, or in combination with Crizotinib, and Plasma Concentrations of IDE196 as monotherapy, in combination with Binimetinib, or in combination with Crizotinib. There will be two experimental arms of dose expansion monotherapy where patients will receive IDE196 orally twice daily. There will be two Experimental Dose Escalation Binimetinib Combination arms where patients will receive IDE196 orally twice daily along with Binimetinib orally twice daily. There will also be two experimental Dose Expansion Crizotinib Combination arms where patients receive IDE196 orally twice daily along with Crizotinib orally twice daily. The final arm will receive IDE196 dosed orally, once on Cycle 1 Day 1; thereafter, twice daily (BID) for each 28-day cycle.
Criteria:
Must Have Eastern Cooperative Oncology Group =1 And Expected Life Expectancy Of > 3 Months. Adequate Cardiac Function Represented By Left Ventricular Ejection Fraction (Lvef) = 50%. Prior Chemotherapy Other Therapies As Applicable Or Major Surgeries Must Have Been Completed At Least 4 Weeks Prior To Initiation Of Crizotinib. No Other Malignancy. No Previous Treatment With A Pkc Inhibitor. No Known Msi-H/Dmmr Tumors Who Have Not Previously Received Immune Checkpoint Inhibitors. No Untreated Or Symptomatic Central Nervous System Metastases. No Impaired Cardiac Function. No Prior Therapy Directly Targeting Alk, Met, Or Ros1. No History Of Pneumonitis Or Interstitial Lung Disease.
Keywords:
Phase 1, Solid Tumor
For More Information:
Uc Cancer Center
5135847698
cancer@uchealth.com