Conditions: Cancer
Keywords: ICOS ICOS agonist monoclonal antibody JTX-2011 Anti-PD-1 Nivolumab ICONIC Immunotherapy Immuno-oncology Cancer Solid Tumor Dose Escalation Dose Expansion Anti-CTLA-4 Ipilimumab Pembrolizumab
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 242
Healthy volunteers: no

Brief summary:
JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

Detailed description:
JTX-2011 is an agonist monoclonal antibody that specifically binds to the Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, PK, PD, and preliminary efficacy of the ICOS agonist monoclonal antibody JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent and the combination therapies, followed by an expansion phase in specified tumor types for single agent and the combination therapies.

Arms:
arm 1: Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion arm 2: Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion arm 3: Phase 2 expansion of JTX-2011 by IV infusion arm 4: Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion arm 5: Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion arm 6: Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion arm 7: Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion arm 8: Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion

Interventions: intervention 1: JTX-2011 intervention 2: Nivolumab intervention 3: Ipilimumab intervention 4: Pembrolizumab
Intervention descriptions: intervention 1: Specified dose on specified days intervention 2: Specified dose on specified days intervention 3: Specified dose on specified days intervention 4: Specified dose on specified days

Protocol document:
Prot_000.pdf: 





















































































































































































































































































































SAP_001.pdf: