> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-ak112-with-or-without-ak117-in-metastatic-d88617cf-4618-4e92-ab66-291562d2c81a > Record changed: 2026-11-04 # A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer NCT05382442 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) Participants 254 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) Lead sponsor Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) Start date 2022-06-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Short title** A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Official title** A Phase II Study of AK112 With or Without AK117 for Patients With Metastatic Colorectal Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) ## Dates **Completion date** 2028-08-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **First posted** 2022-05-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Registry last updated** 2025-10-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Primary completion date** 2026-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Start date** 2022-06-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) ## Size and sites **Participants** 254 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Planned participants** 254 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Lead sponsor** Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) ## Identifiers **Registry ID** NCT05382442 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **ClinicalTrials.gov ID** NCT05382442 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) ## Outcomes ### Primary outcomes 1. Objective response rates (ORR) Timeframe: Up to approximately 2 years ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1 2. Number of participants with adverse events (AEs) Timeframe: 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. ### Secondary outcomes 1. Disease control rate (DCR) Timeframe: Up to approximately 2 years Disease control rate (DCR) is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST V1.1 2. Duration of response (DOR) Timeframe: Up to approximately 2 years DOR is defined for participants who had an objective response as the time from the first occurrence of a documented confirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause,whichever occurred first 3. Time to response (TTR) Timeframe: Up to approximately 2 years TTR is defined for participants who had an objective response as the time from the start of treatment to the first occurrence of a documented unconfirmed response (CR or PR) . 4. Progression-free survival (PFS) Timeframe: Up to approximately 2 years PFS is defined as the time from the start of treatment till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first). 5. Progression-free survival 2 (PFS2) Timeframe: Up to approximately 2 years PFS 2 is defined as the time from the start of treatment till the second documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first). 6. Overall survival (OS) Timeframe: Up to approximately 2 years Overall survival is defined as the time from the start of treatment until death due to any cause. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) ## Sites - Summit Therapeutics Research SiteLos Angeles, United States - Summit Therapeutics Research SiteMurrieta, United States - Summit Therapeutics Research SiteFairfax, United States - The Sixth Hospital,Sun Yat-sen UniversityGuanzhou, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05382442) ## Related records ### Drugs (6) - [Capecitabine](https://trialight.com/data/asset/capecitabine-a5be3dfa-a85f-4c85-8c62-f4ceb74e5f99.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Irinotecan](https://trialight.com/data/asset/irinotecan-a601fe30-4b46-4a3b-bf58-6c490646db73.md) - [Ivonescimab](https://trialight.com/data/asset/ivonescimab-abc25b61-44c5-4a6f-99eb-c59828f17211.md) - [Leucovorin](https://trialight.com/data/asset/leucovorin-8525767e-3f7d-4a78-b2d8-bef4282903ea.md) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) ### Collaborators (1) - [Summit Therapeutics](https://trialight.com/data/company/summit-therapeutics-90e22a13-4ed3-42cf-b081-43a343878f39.md) ### Lead sponsors (1) - [Akeso](https://trialight.com/data/company/akeso-7431fe55-b110-4314-a667-5e8a9af91fc3.md) ### Conditions (1) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) Primary condition ### Targets (3) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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