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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-27

Study Completion Date

2028-08-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

AK112

Intervention Type DRUG

AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity

AK117

Intervention Type DRUG

AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity

Oxaliplatin

Intervention Type DRUG

Oxaliplatin via IV infusion

Capecitabine

Intervention Type 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

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.

Group Type EXPERIMENTAL

AK112

Intervention Type DRUG

AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity

AK117

Intervention Type DRUG

AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity

Oxaliplatin

Intervention Type DRUG

Oxaliplatin via IV infusion

Irinotecan

Intervention Type DRUG

Irinotecan via IV infusion

Leucovorin

Intervention Type DRUG

Leucovorin via IV infusion

5-fluorouracil

Intervention Type DRUG

5-fluorouracil via IV infusion

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)

Group Type EXPERIMENTAL

AK112

Intervention Type DRUG

AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity

Oxaliplatin

Intervention Type DRUG

Oxaliplatin via IV infusion

Capecitabine

Intervention Type 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

Intervention Type DRUG

Irinotecan via IV infusion

Leucovorin

Intervention Type DRUG

Leucovorin via IV infusion

5-fluorouracil

Intervention Type DRUG

5-fluorouracil via IV infusion

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)

Group Type EXPERIMENTAL

AK112

Intervention Type DRUG

AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity

AK117

Intervention Type DRUG

AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity

Oxaliplatin

Intervention Type DRUG

Oxaliplatin via IV infusion

Capecitabine

Intervention Type 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

Intervention Type DRUG

Irinotecan via IV infusion

Leucovorin

Intervention Type DRUG

Leucovorin via IV infusion

5-fluorouracil

Intervention Type DRUG

5-fluorouracil via IV infusion

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).

Group Type EXPERIMENTAL

AK112

Intervention Type DRUG

AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity

Oxaliplatin

Intervention Type DRUG

Oxaliplatin via IV infusion

Capecitabine

Intervention Type 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

Intervention Type DRUG

Irinotecan via IV infusion

Leucovorin

Intervention Type DRUG

Leucovorin via IV infusion

5-fluorouracil

Intervention Type DRUG

5-fluorouracil via IV infusion

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)

Group Type EXPERIMENTAL

AK112

Intervention Type DRUG

AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity

AK117

Intervention Type DRUG

AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity

Oxaliplatin

Intervention Type DRUG

Oxaliplatin via IV infusion

Capecitabine

Intervention Type 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

Intervention Type DRUG

Irinotecan via IV infusion

Leucovorin

Intervention Type DRUG

Leucovorin via IV infusion

5-fluorouracil

Intervention Type DRUG

5-fluorouracil via IV infusion

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)

Group Type EXPERIMENTAL

AK112

Intervention Type DRUG

AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity

AK117

Intervention Type DRUG

AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity

Oxaliplatin

Intervention Type DRUG

Oxaliplatin via IV infusion

Capecitabine

Intervention Type 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

Intervention Type DRUG

Irinotecan via IV infusion

Leucovorin

Intervention Type DRUG

Leucovorin via IV infusion

5-fluorouracil

Intervention Type DRUG

5-fluorouracil via IV infusion

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.

Group Type EXPERIMENTAL

AK112

Intervention Type DRUG

AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity

Oxaliplatin

Intervention Type DRUG

Oxaliplatin via IV infusion

Leucovorin

Intervention Type DRUG

Leucovorin via IV infusion

5-fluorouracil

Intervention Type DRUG

5-fluorouracil via IV infusion

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.

Group Type EXPERIMENTAL

AK112

Intervention Type DRUG

AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity

Oxaliplatin

Intervention Type DRUG

Oxaliplatin via IV infusion

Leucovorin

Intervention Type DRUG

Leucovorin via IV infusion

5-fluorouracil

Intervention Type DRUG

5-fluorouracil via IV infusion

Part 2 cohort 1(AK112)

Subjects receive AK112 until disease progression or unacceptable toxicity AK112 (until disease progression, unacceptable toxicity or patient's refusal)

Group Type EXPERIMENTAL

AK112

Intervention Type DRUG

AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity

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)

Group Type EXPERIMENTAL

AK112

Intervention Type DRUG

AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity

AK117

Intervention Type DRUG

AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity

Interventions

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AK112

AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity

Intervention Type DRUG

AK117

AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity

Intervention Type DRUG

Oxaliplatin

Oxaliplatin via IV infusion

Intervention Type DRUG

Capecitabine

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

Intervention Type DRUG

Irinotecan

Irinotecan via IV infusion

Intervention Type DRUG

Leucovorin

Leucovorin via IV infusion

Intervention Type DRUG

5-fluorouracil

5-fluorouracil via IV infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically proven diagnosis of colorectal adenocarcinoma
* Part1: Subjects who have not previously received any systemic antitumor therapy and who have previously received neoadjuvant or adjuvant therapy, the first detection of recurrence or metastasis should be ≥12 months after the last administration of neoadjuvant or adjuvant therapy
* Part2: Subjects who have previously received systemic therapy including fluorouracil, oxaliplatin, irinotecan, bevacizumab or anti-EGFR antibodies or could not tolerate or have contraindications to standard treatment
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Measurable disease as defined by RECIST v1.1
* Adequate hematologic and organ function

Exclusion Criteria

* Known MSI-H(Microsatellite-Instability-High) or dMMR(Mismatch Repair-Deficient)
* Prior treatment with immunotherapy, including immune checkpoint inhibitors , immune checkpoint agonists, immune cell therapy and any treatment targeting tumor immune pathway
* History of autoimmune disease
* Prior allogeneic stem cell or solid organ transplantation
* Positive test for human immunodeficiency virus,Active hepatitis B or hepatitis C
* Receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment
* Pregnancy or lactation
* Dysphagia

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No