Metastatic Colorectal Cancer
Conditions
Brief 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.
Interventions
DRUGOxaliplatin
Oxaliplatin via IV infusion
DRUGAK112
AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity
DRUGAK117
AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity
DRUGCapecitabine
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
DRUGIrinotecan
Irinotecan via IV infusion
DRUGLeucovorin
Leucovorin via IV infusion
DRUG5-fluorouracil
5-fluorouracil via IV infusion
Sponsors
Summit Therapeutics
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rates (ORR) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to response (TTR) | 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) . |
| Progression-free survival (PFS) | 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). |
| Disease control rate (DCR) | 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 |
| Overall survival (OS) | Up to approximately 2 years | Overall survival is defined as the time from the start of treatment until death due to any cause. |
| Progression-free survival 2 (PFS2) | 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). |
| Duration of response (DOR) | 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 |
Countries
China, United States
Outcome results
None listed