A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

Studien-Informationen

Ein-/Ausschlusskriterien

Studien-Rationale

Studien-Arme

• Experimental: Inavolisib + Cetuximab
  Participants will receive 9 milligrams (mg) of inavolisib by mouth once daily (QD) on Days 8-28 of Cycle 1, then QD on Days 1-28 from Cycle 2 onwards (1 cycle=28 days). Participants will also receive cetuximab intravenous (IV) infusion 400 mg/m2 body surface area on Day 1 of Cycle 1. All subsequent weekly (QW) doses will be 250 mg/m2 each.
• Experimental: Inavolisib + Bevacizumab
  Participants will receive 9 mg of inavolisib by mouth QD combined with bevacizumab 15 milligram/kilogram (mg/kg) IV once every three weeks (Q3W) on Day 1 of each cycle (1 cycle=21 days).
• Experimental: Atezolizumab + Tiragolumab + Bevacizumab
  Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle, combined with tiragolumab at a dose of 600 mg IV infusion on Day 1 of each cycle and bevacizumab IV infusion at a dose of 15 mg/kg on Day 1 of each cycle. (Cycle length=21 days)
• Experimental: Atezolizumab + Tiragolumab
  Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle combined with tiragolumab 600 mg IV infusion on Day 1 of each cycle. (Cycle length=21 days)
• Experimental: Atezolizumab + SY-5609
  Participants will receive 1680 mg of atezolizumab by IV infusion on Day 1 of each cycle Q4W in repeated 28-day cycles combined with SY-5609 at a dose of 3, 4, 5, 6, 7 or 10 mg by mouth for 7 days, followed by 7 days off. (Cycle length=28 days) Open in the United States only. Enrollment is closed.
• Experimental: Divarasib + Cetuximab + FOLFOX
  Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFOX on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days)
• Experimental: Divarasib + Cetuximab
  Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days)
• Experimental: Divarasib + Cetuximab + FOLFIRI
  Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFIRI on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days)

Geprüfte Regime

• Inavolisib:
  Inavolisib will be administered orally as per schedule specified in the respective arms.
• Bevacizumab (Avastin):
  Bevacizumab IV will be administered as per schedule specified in the respective arm.
• Cetuximab:
  Cetuximab IV will be administered as per schedule specified in the respective arm.
• Atezolizumab (Tecentriq):
  Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.
• Tiragolumab:
  Tiragolumab IV infusion will be administered as per schedule specified in the respective arm.
• SY-5609:
  SY-5609 will be administered by mouth as per schedule specified in the respective arm.
• Divarasib (GDC-6036):
  Divarasib will be administered orally as per schedule specified in the respective arms.
• FOLFOX:
  FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm.
• FOLFIRI:
  FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm.

Quelle: ClinicalTrials.gov