Full Title
A Phase 1b, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 in Subjects With Advanced Solid Tumors With KRAS p.G12C MutationPurpose
The purpose of this study is to assess the safety of giving the drug AMG 510 (sotorasib) with other drugs - such as a MEK inhibitor, a SHP2 allosteric inhibitor, a PD-L1 inhibitor, a pan-ErbB tyrosine kinase inhibitor, or an EGFR inhibitor - in patients with solid tumors that contain a particular mutation called G12C in the KRAS gene and which spread despite prior treatment. AMG 510 traps the mutant KRAS protein and prevents it from signaling to other cells, thereby slowing or stopping cancer growth.
The other drugs work to enhance the effects of AMG 510 by either shutting down KRAS signaling or activating the immune system to attack the cancer. AMG 510 is taken orally (by mouth), and the other drugs are either taken orally or intravenously (by vein).
Who Can Join
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a solid tumor that contains the KRAS G12C mutation and has spread despite prior treatment.
- Patients with metastatic non-small cell lung cancer must have previously received immunotherapy or chemotherapy, and patients with metastatic colorectal cancer must have had two prior regimens of standard chemotherapy for that cancer.
- Patients with primary brain tumors may not participate.
- At least 4 weeks must pass since finishing chemotherapy or immunotherapy and 2 weeks since radiation therapy and the first day of a patient’s participation in the study.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 18 and older.
Contact
For more information about this study and to see if you can join, please call 646-888-4226.