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NCT Number: NCT05382442

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Sixth Hospital,Sun Yat-sen University, Guanzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Objective response rates (ORR)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: Up to approximately 2 years

    Overall survival is defined as the time from the start of treatment until death due to any cause.

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Collaborators

  • Summit Therapeutics

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
May 19, 2022
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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