Metastatic Colorectal CancerPhase 2NCT05382442
A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer
A Phase 2 study testing AK112, AK117 and Oxaliplatin in people with Metastatic Colorectal Cancer, run by Akeso at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- AK112, AK117 and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 27 Jun 2022to 12 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Summit Therapeutics Research Site
Fairfax, Virginia, 22031
Summit Therapeutics Research Site
Los Angeles, California, 90067
Summit Therapeutics Research Site
Murrieta, California, 92562
China1 site
The Sixth Hospital,Sun Yat-sen University
Guanzhou, Guangdong, 510000
About this study
Official title: A Phase II Study of AK112 With or Without AK117 for Patients With 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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- AK112, AK117, Oxaliplatin, Capecitabine, Irinotecan
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK112Drug
AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity
AK117Drug
AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity
OxaliplatinDrug
Oxaliplatin via IV infusion
CapecitabineDrug
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
IrinotecanDrug
Irinotecan via IV infusion
LeucovorinDrug
Leucovorin via IV infusion
5-fluorouracilDrug
5-fluorouracil via IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: AK112; Drug: AK117; Drug: Oxaliplatin; Drug: Capecitabine |
| 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. Receives: Drug: AK112; Drug: AK117; Drug: Oxaliplatin; Drug: Irinotecan; Drug: Leucovorin; Drug: 5-fluorouracil |
| 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) Receives: Drug: AK112; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Irinotecan; Drug: Leucovorin; Drug: 5-fluorouracil |
| 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) Receives: Drug: AK112; Drug: AK117; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Irinotecan; Drug: Leucovorin; Drug: 5-fluorouracil |
| 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). Receives: Drug: AK112; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Irinotecan; Drug: Leucovorin; Drug: 5-fluorouracil |
| 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) Receives: Drug: AK112; Drug: AK117; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Irinotecan; Drug: Leucovorin; Drug: 5-fluorouracil |
| 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) Receives: Drug: AK112; Drug: AK117; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Irinotecan; Drug: Leucovorin; Drug: 5-fluorouracil |
| 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. Receives: Drug: AK112; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-fluorouracil |
| 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)
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. Receives: Drug: AK112; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-fluorouracil |
| 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) Receives: Drug: AK112 |
| 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) Receives: Drug: AK112; Drug: AK117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rates (ORR)
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1
Measured: Up to approximately 2 years
Number of participants with adverse events (AEs)
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.
Measured: Up to approximately 2 years
Secondary outcomes (6)
Disease control rate (DCR)
Disease control rate (DCR) is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST V1.1
Measured: Up to approximately 2 years
Duration of response (DOR)
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
Measured: Up to approximately 2 years
Time to response (TTR)
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) .
Measured: Up to approximately 2 years
Progression-free survival (PFS)
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).
Measured: Up to approximately 2 years
Progression-free survival 2 (PFS2)
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).
Measured: Up to approximately 2 years
Overall survival (OS)
Overall survival is defined as the time from the start of treatment until death due to any cause.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start27 Jun 2022
- Primary completion15 May 2026 (estimated)
- Study completion12 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Summit Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382442
- Sponsor's protocol ID
- AK112-206
- Status last verified
- Oct 2025
- First submitted
- 16 May 2022
- Last updated
- 14 Oct 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of AK112 With or Without AK117 for Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05382442
- Acronym / sponsor ID
- AK112-206
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Collaborators
- Summit Therapeutics
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 12 Aug 2028 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part 1_Chemotherapy Regimen Selection Stage Group A(AK112+AK117+XELOX) | Experimental | Drug: AK112, Drug: AK117, Drug: Oxaliplatin, Drug: CapecitabineAK112+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. |
| Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI) | Experimental | Drug: AK112, Drug: AK117, Drug: Oxaliplatin, Drug: Irinotecan, Drug: Leucovorin, Drug: 5-fluorouracilAK112+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. |
| Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy) | Experimental | Drug: AK112, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Irinotecan, Drug: Leucovorin, Drug: 5-fluorouracilAK112 (Dose1) +Chemotherapy(Decided by Chemotherapy Regimen Selection Stage) AK112 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage) |
| Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy) | Experimental | Drug: AK112, Drug: AK117, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Irinotecan, Drug: Leucovorin, Drug: 5-fluorouracilAK112 (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) |
| Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy) | Experimental | Drug: AK112, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Irinotecan, Drug: Leucovorin, Drug: 5-fluorouracilAK112 (Dose2)+Chemotherapy(Decided by Chemotherapy Regimen Selection Stage). AK112 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage). |
| Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy) | Experimental | Drug: AK112, Drug: AK117, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Irinotecan, Drug: Leucovorin, Drug: 5-fluorouracilAK112(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) |
| Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy) | Experimental | Drug: AK112, Drug: AK117, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Irinotecan, Drug: Leucovorin, Drug: 5-fluorouracilAK112(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) |
| Part 1_Extension Stage Group F (AK112 DS1 + mFOLFOX6) | Experimental | Drug: AK112, Drug: Oxaliplatin, Drug: Leucovorin, Drug: 5-fluorouracilAK112 (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. |
| Part 1_Extension Stage Group G (AK112 DS2+mFOLFOX6) | Experimental | Drug: AK112, Drug: Oxaliplatin, Drug: Leucovorin, Drug: 5-fluorouracilAK112 (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) 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. |
| Part 2 cohort 1(AK112) | Experimental | Drug: AK112Subjects receive AK112 until disease progression or unacceptable toxicity AK112 (until disease progression, unacceptable toxicity or patient's refusal) |
| Part 2 cohort 2(AK112+AK117) | Experimental | Drug: AK112, Drug: AK117Subjects receive AK117 and AK112 until disease progression or unacceptable toxicity AK112 and AK117 ( until disease progression, unacceptable toxicity or patient's refusal) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK112AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity | Drug | Part 1_Chemotherapy Regimen Selection Stage Group A(AK112+AK117+XELOX), Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI), Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy), Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy), Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy), Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy), Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy), Part 1_Extension Stage Group F (AK112 DS1 + mFOLFOX6), Part 1_Extension Stage Group G (AK112 DS2+mFOLFOX6), Part 2 cohort 1(AK112), Part 2 cohort 2(AK112+AK117) |
| AK117AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity | Drug | Part 1_Chemotherapy Regimen Selection Stage Group A(AK112+AK117+XELOX), Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI), Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy), Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy), Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy), Part 2 cohort 2(AK112+AK117) |
| OxaliplatinOxaliplatin via IV infusion | Drug | Part 1_Chemotherapy Regimen Selection Stage Group A(AK112+AK117+XELOX), Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI), Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy), Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy), Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy), Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy), Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy), Part 1_Extension Stage Group F (AK112 DS1 + mFOLFOX6), Part 1_Extension Stage Group G (AK112 DS2+mFOLFOX6) |
| CapecitabineCapecitabine 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 | Drug | Part 1_Chemotherapy Regimen Selection Stage Group A(AK112+AK117+XELOX), Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy), Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy), Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy), Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy), Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy) |
| IrinotecanIrinotecan via IV infusion | Drug | Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI), Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy), Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy), Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy), Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy), Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy) |
| LeucovorinLeucovorin via IV infusion | Drug | Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI), Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy), Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy), Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy), Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy), Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy), Part 1_Extension Stage Group F (AK112 DS1 + mFOLFOX6), Part 1_Extension Stage Group G (AK112 DS2+mFOLFOX6) |
| 5-fluorouracil5-fluorouracil via IV infusion | Drug | Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI), Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy), Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy), Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy), Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy), Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy), Part 1_Extension Stage Group F (AK112 DS1 + mFOLFOX6), Part 1_Extension Stage Group G (AK112 DS2+mFOLFOX6) |
Primary outcome
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
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.
6 secondary outcomes
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 2 years
Time to response (TTR)
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Time frame: Up to approximately 2 years
Progression-free survival 2 (PFS2)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK112, AK117 and Oxaliplatin in people with Metastatic Colorectal Cancer, run by Akeso at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rates (ORR) (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.