临床试验/NCT05382442

NCT05382442进行中（未招募）2 期

A Phase II Study of AK112 With or Without AK117 for Patients With Metastatic Colorectal Cancer

Akeso2 个研究点分布在 2 个国家目标入组 254 人开始时间: 2022年6月27日最近更新: 2025年10月14日

适应症

干预措施

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方
入组人数: 254
试验地点: 2
主要终点: Objective response rates (ORR)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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

研究组 & 干预措施

Part 1_Chemotherapy Regimen Selection Stage Group A(AK112+AK117+XELOX)

Experimental

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.

干预措施: AK112 (Drug)

Part 1_Chemotherapy Regimen Selection Stage Group A(AK112+AK117+XELOX)

Experimental

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)

干预措施: AK117 (Drug)

Part 1_Chemotherapy Regimen Selection Stage Group A(AK112+AK117+XELOX)

Experimental

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)

干预措施: Oxaliplatin (Drug)

Part 1_Chemotherapy Regimen Selection Stage Group A(AK112+AK117+XELOX)

Experimental

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)

干预措施: Capecitabine (Drug)

Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI)

Experimental

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.

干预措施: AK112 (Drug)

Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI)

Experimental

AK112+AK117+FOLFOXIRI

干预措施: AK117 (Drug)

Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI)

Experimental

AK112+AK117+FOLFOXIRI

干预措施: Oxaliplatin (Drug)

Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI)

Experimental

AK112+AK117+FOLFOXIRI

干预措施: Irinotecan (Drug)

Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI)

Experimental

AK112+AK117+FOLFOXIRI

干预措施: Leucovorin (Drug)

Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI)

Experimental

AK112+AK117+FOLFOXIRI

干预措施: 5-fluorouracil (Drug)

Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy)

Experimental

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)

干预措施: AK112 (Drug)

Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy)

Experimental

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)

干预措施: Oxaliplatin (Drug)

Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy)

Experimental

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)

干预措施: Capecitabine (Drug)

Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy)

Experimental

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)

干预措施: Irinotecan (Drug)

Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy)

Experimental

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)

干预措施: Leucovorin (Drug)

Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy)

Experimental

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)

干预措施: 5-fluorouracil (Drug)

Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy)

Experimental

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)

干预措施: AK112 (Drug)

Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy)

Experimental

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)

干预措施: AK117 (Drug)

Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy)

Experimental

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)

干预措施: Oxaliplatin (Drug)

Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy)

Experimental

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)

干预措施: Capecitabine (Drug)

Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy)

Experimental

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)

干预措施: Irinotecan (Drug)

Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy)

Experimental

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)

干预措施: Leucovorin (Drug)

Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy)

Experimental

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)

干预措施: 5-fluorouracil (Drug)

Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy)

Experimental

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).

干预措施: AK112 (Drug)

Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy)

Experimental

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).

干预措施: Oxaliplatin (Drug)

Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy)

Experimental

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).

干预措施: Capecitabine (Drug)

Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy)

Experimental

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).

干预措施: Irinotecan (Drug)

Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy)

Experimental

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).

干预措施: Leucovorin (Drug)

Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy)

Experimental

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).

干预措施: 5-fluorouracil (Drug)

Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy)

Experimental

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)

干预措施: AK112 (Drug)

Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy)

Experimental

干预措施: AK117 (Drug)

Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy)

Experimental

干预措施: Oxaliplatin (Drug)

Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy)

Experimental

干预措施: Capecitabine (Drug)

Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy)

Experimental

干预措施: Irinotecan (Drug)

Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy)

Experimental

干预措施: Leucovorin (Drug)

Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy)

Experimental

干预措施: 5-fluorouracil (Drug)

Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy)

Experimental

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)

干预措施: AK112 (Drug)

Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy)

Experimental

干预措施: AK117 (Drug)

Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy)

Experimental

干预措施: Oxaliplatin (Drug)

Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy)

Experimental

干预措施: Capecitabine (Drug)

Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy)

Experimental

干预措施: Irinotecan (Drug)

Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy)

Experimental

干预措施: Leucovorin (Drug)

Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy)

Experimental

干预措施: 5-fluorouracil (Drug)

Part 1_Extension Stage Group F (AK112 DS1 + mFOLFOX6)

Experimental

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.

干预措施: AK112 (Drug)

Part 1_Extension Stage Group F (AK112 DS1 + mFOLFOX6)

Experimental

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).

干预措施: Oxaliplatin (Drug)

Part 1_Extension Stage Group F (AK112 DS1 + mFOLFOX6)

Experimental

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).

干预措施: Leucovorin (Drug)

Part 1_Extension Stage Group F (AK112 DS1 + mFOLFOX6)

Experimental

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).

干预措施: 5-fluorouracil (Drug)

Part 1_Extension Stage Group G (AK112 DS2+mFOLFOX6)

Experimental

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)

干预措施: AK112 (Drug)

Part 1_Extension Stage Group G (AK112 DS2+mFOLFOX6)

Experimental

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)

干预措施: Oxaliplatin (Drug)

Part 1_Extension Stage Group G (AK112 DS2+mFOLFOX6)

Experimental

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)

干预措施: Leucovorin (Drug)

Part 1_Extension Stage Group G (AK112 DS2+mFOLFOX6)

Experimental

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)

干预措施: 5-fluorouracil (Drug)

Part 2 cohort 1(AK112)

Experimental

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

干预措施: AK112 (Drug)

Part 2 cohort 2(AK112+AK117)

Experimental

Subjects receive AK117 and AK112 until disease progression or unacceptable toxicity AK112 and AK117 ( until disease progression, unacceptable toxicity or patient's refusal)

干预措施: AK112 (Drug)

Part 2 cohort 2(AK112+AK117)

Experimental

Subjects receive AK117 and AK112 until disease progression or unacceptable toxicity AK112 and AK117 ( until disease progression, unacceptable toxicity or patient's refusal)

干预措施: AK117 (Drug)

结局指标

主要结局

Objective response rates (ORR)

时间窗: Up to approximately 2 years

ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1

Number of participants with adverse events (AEs)

时间窗: Up to approximately 2 years

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

次要结局

Disease control rate (DCR)(Up to approximately 2 years)
Duration of response (DOR)(Up to approximately 2 years)
Time to response (TTR)(Up to approximately 2 years)
Progression-free survival (PFS)(Up to approximately 2 years)
Progression-free survival 2 (PFS2)(Up to approximately 2 years)
Overall survival (OS)(Up to approximately 2 years)

研究者

发起方

Akeso

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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