A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Akeso
Study ID
NCT05382442
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AK112 — DRUG
    AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity
  • AK117 — DRUG
    AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity
  • Oxaliplatin — DRUG
    Oxaliplatin via IV infusion
  • Capecitabine — DRUG
    Capecitabine via oral,The total daily dose was 2000mg/sqm, Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days
  • Irinotecan — DRUG
    Irinotecan via IV infusion
  • Leucovorin — DRUG
    Leucovorin via IV infusion
  • 5-fluorouracil — DRUG
    5-fluorouracil via IV infusion

Study Details

This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK112 with or without AK117 in participants with metastatic colorectal cancer who are not suitable for surgery.

Key Dates

Start date
Jun 27, 2022
Status verified
Oct 2025
Primary completion
May 15, 2026
Completion
Aug 12, 2028

Study Design

Enrollment
254 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1_Chemotherapy Regimen Selection Stage Group A(AK112+AK117+XELOX)
    AK112+AK117+XELOX AK112 and AK117 and XELOX(Oxaliplatin 130 mg/sqm iv day 1, Capecitabine via oral, the total daily dose was 2000mg/sqm, day1-14) If no progression occurs during AK112 plus AK117 plus XELOX, patients will receive maintenance capecitabine plus AK112 plus AK117 at the same dose used at the last cycle of the induction treatment. Capecitabine plus AK112 plus AK117 will be repeated every 3 weeks until disease progression, unacceptable toxicity or patient's refusal.
  • Experimental: Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI)
    AK112+AK117+FOLFOXIRI AK112 and AK117 and FOLFOXIRI(Irinotecan 150-165 mg/sqm iv day 1, Oxaliplatin 85 mg/sqm iv day 1, Leucovorin(LV) 400 mg/sqm iv day 1, 5-fluorouracil(5-FU) 2400-2800 mg/sqm 46-48 hours continuous infusion, starting on day 1) If no progression occurs during AK112 plus AK117 plus FOLFOXIRI, patients will receive maintenance 5-FU/LV plus AK112 plus AK117 at the same dose used at the last cycle of the induction treatment. 5-FU/LV plus AK112 plus AK117 will be repeated biweekly until disease progression, unacceptable toxicity or patient's refusal.
  • Experimental: Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy)
    AK112 (Dose1) +Chemotherapy(Decided by Chemotherapy Regimen Selection Stage) AK112 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage)
  • Experimental: Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy)
    AK112 (Dose1) +AK117 (Dose1) +Chemotherapy(Decided by Chemotherapy Regimen Selection Stage) AK112 and AK117 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage)
  • Experimental: Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy)
    AK112 (Dose2)+Chemotherapy(Decided by Chemotherapy Regimen Selection Stage). AK112 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage).
  • Experimental: Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy)
    AK112(Dose2) + AK117(Dose2)+Chemotherapy(Decided by Chemotherapy Regimen Selection Stage) AK112 and AK117 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage)
  • Experimental: Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy)
    AK112(Dose2)+AK117(Dose1)+Chemotherapy(Decided by Chemotherapy Regimen Selection Stage) AK112 and AK117 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage)
  • Experimental: Part 1_Extension Stage Group F (AK112 DS1 + mFOLFOX6)
    AK112 (Dose1) +mFOLFOX6 ( Oxaliplatin 85 mg/sqm IV day 1, Leucovorin 400 mg/sqm IV day 1, 5-fluorouracil(5-FU) 2400 mg/sqm 46-48 hours continuous infusion, starting on day 1). If no progression occurs during AK112 plus mFOLFOX6, patients will receive maintenance 5- FU/LV plus AK112 at the same dose used at the last cycle of the induction treatment. 5-FU/LV plus AK112 will be repeated biweekly until disease progression, unacceptable toxicity or patient's refusal.
  • Experimental: Part 1_Extension Stage Group G (AK112 DS2+mFOLFOX6)
    AK112 (Dose2) +mFOLFOX6 ( Oxaliplatin 85 mg/sqm IV day 1, Leucovorin 400 mg/sqm IV day 1, 5-fluorouracil(5-FU) 2400 mg/sqm 46-48 hours continuous infusion, starting on day 1) If no progression occurs during AK112 plus mFOLFOX6, patients will receive maintenance 5- FU/LV plus AK112 at the same dose used at the last cycle of the induction treatment. 5-FU/LV plus AK112 will be repeated biweekly until disease progression, unacceptable toxicity or patient's refusal.
  • Experimental: Part 2 cohort 1(AK112)
    Subjects receive AK112 until disease progression or unacceptable toxicity AK112 (until disease progression, unacceptable toxicity or patient's refusal)
  • Experimental: Part 2 cohort 2(AK112+AK117)
    Subjects receive AK117 and AK112 until disease progression or unacceptable toxicity AK112 and AK117 ( until disease progression, unacceptable toxicity or patient's refusal)

Primary Outcome Measure

Objective response rates (ORR) [ Time Frame: Up to approximately 2 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Summit Therapeutics Research SiteLos AngelesCalifornia90067-
Summit Therapeutics Research SiteMurrietaCalifornia92562-
Summit Therapeutics Research SiteFairfaxVirginia22031-

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