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

NCT05382442
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Participants
254
clinicaltrials.gov
Lead sponsor
Akeso
clinicaltrials.gov
Start date
2022-06-27
clinicaltrials.gov
Number of sites
4
clinicaltrials.gov

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.
clinicaltrials.gov
Short title
A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer
clinicaltrials.gov
Official title
A Phase II Study of AK112 With or Without AK117 for Patients With Metastatic Colorectal Cancer
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2028-08-12
clinicaltrials.gov
First posted
2022-05-19
clinicaltrials.gov
Registry last updated
2025-10-14
clinicaltrials.gov
Primary completion date
2026-05-15
clinicaltrials.gov
Start date
2022-06-27
clinicaltrials.gov

Participants
254
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
254
clinicaltrials.gov
Protocol amendments
3
clinicaltrials.gov
Number of sites
4
clinicaltrials.gov

Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Akeso
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05382442
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05382442
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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.

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (6)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (3)