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A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors

Phase I

This study is an open-label, multi-center, dose-escalation, dose expansion study in adult subjects with advanced solid tumors. The study will evaluate the safety, tolerability, PK, and preliminary anti-tumor efficacy of SM08502 administered orally (PO), once daily (QD), following a 5 days on 2 days off treatment schedule in combination with chemotherapy or hormonal therapy. Alternative dosing schedules may be explored in Part 1 if necessary. The recommended Part 2 dose and schedule for each combination will then be further evaluated in the Part 2 expansion. Dosing will occur in 21- or 28-day cycles (depending on the combination partner) and treatment with SM08502 will continue within each subject unless treatment is discontinued due to toxicity, disease progression, initiation of a new anti-neoplastic therapy, withdrawal of consent, the Sponsor terminates the study, or the subject no longer meets retreatment criteria.
Phase I
I
Schaffer, Kerry
NCT05084859
VICCPHI2179

Telaglenastat, Panitumumab, and Irinotecan Hydrochloride in Treating Patients with Metastatic and Refractory RAS Wildtype Colorectal Cancer

Multiple Cancer Types

This phase I / II trial studies the best dose and side effects of telaglenastat and how well it works with panitumumab and irinotecan hydrochloride in treating patients with RAS wildtype colorectal cancer that has spread to other places in the body and does not respond to treatment. Telaglenastat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving telaglenastat with panitumumab and irinotecan hydrochloride may work better in treating patients with colorectal cancer.
Colon, Rectal
I/II
Berlin, Jordan
NCT03263429
VICCGI1703

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Multiple Cancer Types

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.
Miscellaneous, Phase I
I
Iams, Wade
NCT04185883
VICCPHI2025