Colorectal CancerPhase 1/2NCT05846867
A Phase Ib/II Clinical Study on AK112 Combined or Not Combined With AK119 in pMMR/MSS Colorectal Cancer
A Phase 1/2 study testing AK119, AK112 and Oxaliplatin in people with Colorectal Cancer, run by Akeso at 1 site in China.
Trial summary
This is an open label, multicenter Phase Ib/II clinical study on the efficacy and safety of AK119 and AK112 in combination with or without chemotherapy, and AK112 monotherapy in pMMR/MSS CRC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- AK119, AK112 and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2023to 11 Aug 2026
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to understand and voluntarily sign the written informed consent, which must be signed before the specified research procedure required by the research is implemented.
- Age ≥ 18 when signing the informed consent form (ICF), both male and female。
- Microsatellite stable colorectal cancer confirmed by histopathology; Microsatellite stability was defined as the expression of four common MMR proteins (MLH1, MSH2, MSH6 and PMS2) detected by immunohistochemistry, and all four proteins were positive for pMMR. Or PCR method was used to detect sites (BAT25, BAT26, D5S346, D2S123 and D17S250), and the detection results showed that the stability was microsatellite stability or microsatellite low degree instability.
- The first and second cohorts: recurrent or metastatic colorectal cancer that has failed to undergo at least the second-line standard treatment in the past; The chemotherapy of at least one of the treatment lines is the combination chemotherapy of at least two cytotoxic drugs based on platinum or irinotecan; Definition of treatment failure: disease progression occurs during or after treatment. All patients who change the treatment plan due to drug intolerance are not considered as treatment failure; For subjects who have received induction chemotherapy, concurrent radiotherapy and chemotherapy or adjuvant chemotherapy in the past, if relapse/metastasis occurs within 6 months after the last treatment, the original treatment plan is defined as the first-line treatment plan for the subject.
- The third and fourth cohorts: for patients with advanced colorectal cancer who have not undergone systematic treatment, the recurrence time should be at least 6 months from the end of the last treatment for those who have previously received induction chemotherapy, concurrent radiotherapy and chemotherapy or adjuvant/neoadjuvant chemotherapy.
- Agree to provide archived or freshly obtained tumor tissue samples within 2 years before the first administration (preferably newly obtained tumor tissue samples) About 20 unstained FFPE pathological sections (if the sample size is not enough, only 10 unstained FFPE pathological sections can be provided with the approval of medical inspectors FFPE pathological section).
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- According to RECIST v1.1 standard, subjects have at least one measurable target lesion; The focus that has received radiotherapy is not selected as the target lesion, unless the radiotherapy focus is the only measurable focus and the progress is determined according to the imaging, it can be considered as the target lesion.
- The Eastern Cancer Cooperation Organization (ECOG) physical state score is 0 or 1.
- The expected survival period is ≥ 3 months.
Who cannot join
- Pathological examination confirmed other pathological types, such as squamous cell carcinoma, sarcoma or undifferentiated carcinoma, gastrointestinal stromal tumor, etc.
- Palliative local treatment for non-target lesions within 2 weeks before the first administration; Have received systemic non-specific immunomodulation therapy (such as interleukin, interferon, thymosin, etc.) within 2 weeks before the first administration; Received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications within 2 weeks before the first administration。
- Had been treated with anti-CD73 inhibitors, immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (such as antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), immune cell therapy (such as CAR-T) and other therapies aimed at tumor immune mechanism.
- There is a history of gastrointestinal perforation and fistula within 6 months before the first administration. If the perforation or fistula has been removed or repaired, and the researcher judges that the disease has recovered or alleviated, it can be admitted into the group.
- Active or inactive Inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) previously recorded. Inability to swallow, malabsorption syndrome, or uncontrollable nausea, vomiting, diarrhea or other gastrointestinal diseases that seriously affect the use and absorption of drugs.
- Except for the tumor that the subject had at the time of enrollment, there was active malignant tumor in the previous five years. However, the tumors participating in the study and cured local tumors are excluded, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, localized prostate cancer, etc.
- At the same time, another interventional clinical study was enrolled.
- Receive the last systemic anti-tumor treatment within 3 weeks before the first administration; Received small molecular TKI treatment within 2 weeks before the first administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Multicenter Phase Ib/II Clinical Study on the Efficacy and Safety of AK119 and AK112, Either in Combination or Not, With Chemotherapy, and AK112 Monotherapy in pMMR/MSS CRC
This is an open label, multicenter Phase Ib/II clinical study on the efficacy and safety of AK119 and AK112 in combination with or without chemotherapy, and AK112 monotherapy in pMMR/MSS CRC
Read the detailed description
This study is an open, multicenter, Ib/II phase clinical trial conducted in China. The research plan is divided into 5 queues. A total of 130-170 subjects were enrolled. Subjects who meet the research criteria will receive treatment with AK119 and AK112 in combination or without chemotherapy, as well as AK112 monotherapy, every two weeks according to the protocol. The research on the first and second cohorts will be conducted first, and at least two lines of microsatellite stabilized colorectal cancer subjects who have failed standard treatment will be enrolled; Subsequently, a third cohort was conducted, which included microsatellite stabilized colorectal cancer subjects who had failed at least two lines of standard treatment; After preliminary confirmation of the safety and efficacy of AK119 combined with AK112 in the first and second cohorts, and determination of the recommended dose of AK119 for subsequent combination chemotherapy, the study of AK119 and AK112 combined chemotherapy in the fourth and fifth cohorts will be conducted. The fourth and fifth cohorts will include participants with advanced first-line microsatellite stable colorectal cancer who have not received systemic treatment.
- Conditions
- Colorectal Cancer
- Being tested
- AK119, AK112, Oxaliplatin, Irinotecan, Calcium folinate
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK119Drug
AK119 IV every 2 weeks.intravenous infusion
AK112Drug
AK112 IV every 2 weeks.intravenous infusion
OxaliplatinDrug
Oxaliplatin: 85mg/m2, intravenous infusion
IrinotecanDrug
Irinotecan 180mg/m2, intravenous infusion
Calcium folinateDrug
Calcium folinate: 400mg/m2, intravenous infusion
FluorouracilDrug
Fluorouracil 400mg/m2, intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| AK119 20mg/kg+ AK112 20mg/kg | Experimental | Subjects will receive AK119 plus AK112 via intravenously (IV) Q2W, up to 2 years Receives: Drug: AK119; Drug: AK112 |
| AK119 40mg/kg+ AK112 20mg/kg | Experimental | Subjects will receive AK119 plus AK112 via intravenously (IV) Q2W, up to 2 years Receives: Drug: AK119; Drug: AK112 |
| AK119 + AK112 20mg/kg +mFOLFOX6 | Experimental | Subjects will receive AK119 and AK112 plus mFOLFOX6 via intravenously (IV)Q2W, up to 12 cycles. Afterward, AK119 and AK112 will continue to be treated up to 2 years. Receives: Drug: AK119; Drug: AK112; Drug: Oxaliplatin; Drug: Calcium folinate; Drug: Fluorouracil |
| AK119 + AK112 20mg/kg +FOLFIRI | Experimental | Subjects will receive AK119 and AK112 plus FOLFIRI via intravenously (IV)Q2W, up to 12 cycles. Afterward, AK119 and AK112 will continue to be treated up to 2 years. Receives: Drug: AK119; Drug: AK112; Drug: Irinotecan; Drug: Calcium folinate; Drug: Fluorouracil |
| AK112 20mg/kg | Experimental | Subjects will receive AK112 via intravenously (IV) Q2W, up to 2 years Receives: Drug: AK112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or confirmed PR
Measured: Up to 2 years
Number of subjects with adverse events (AEs)
AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Measured: From the time of informed consent signed through 90 days after the last dose of study drug
recommended phaseII dose
Phase II clinical study recommended dose (RP2D) of AK119 and AK112 combined with or without chemotherapy
Measured: 1 year
Secondary outcomes (8)
Progression-free survival (PFS)
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1)
Measured: Up to 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST Version 1.1).
Measured: Up to 2 years
Duration of response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first
Measured: Up to 2 years
Time to response (TTR)
TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR (based on RECIST Version 1.1)
Measured: Up to 2 years
Total survival time (OS) and 12-month OS rate
OS defined as the time from the first dose to death from any cause
Measured: Up to 2 years
Maximum observed concentration (Cmax) of AK119 and AK112
The PK parameters include serum concentrations of AK119 and AK112 at different timepoints after study drug administration.
Measured: From first dose of study drug through last dose up to 100 weeks
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK119 and AK112 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).
Measured: From first dose of study drug through last dose up to 100 weeks
Correlation between biomarkers and efficacy
Correlation between the expression level of PD-L1 and CD73 biomarkers and efficacy ORR, PFS and OS
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start8 May 2023
- Primary completion8 May 2026 (estimated)
- Study completion11 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanqiao Zhang, PhD, Study chair, Cancer Hospital Affiliated to Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846867
- Sponsor's protocol ID
- AK119-202
- Status last verified
- Mar 2026
- First submitted
- 26 Apr 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Phase Ib/II Clinical Study on the Efficacy and Safety of AK119 and AK112, Either in Combination or Not, With Chemotherapy, and AK112 Monotherapy in pMMR/MSS CRC
- ClinicalTrials.gov ID
- NCT05846867
- Acronym / sponsor ID
- AK119-202
- Conditions
- Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 8 May 2023 (actual)
- Primary completion
- 8 May 2026 (estimated)
- Study completion
- 11 Aug 2026 (estimated)
- First posted
- 6 May 2023 (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 is an open label, multicenter Phase Ib/II clinical study on the efficacy and safety of AK119 and AK112 in combination with or without chemotherapy, and AK112 monotherapy in pMMR/MSS CRC
Detailed description
This study is an open, multicenter, Ib/II phase clinical trial conducted in China. The research plan is divided into 5 queues. A total of 130-170 subjects were enrolled. Subjects who meet the research criteria will receive treatment with AK119 and AK112 in combination or without chemotherapy, as well as AK112 monotherapy, every two weeks according to the protocol. The research on the first and second cohorts will be conducted first, and at least two lines of microsatellite stabilized colorectal cancer subjects who have failed standard treatment will be enrolled; Subsequently, a third cohort was conducted, which included microsatellite stabilized colorectal cancer subjects who had failed at least two lines of standard treatment; After preliminary confirmation of the safety and efficacy of AK119 combined with AK112 in the first and second cohorts, and determination of the recommended dose of AK119 for subsequent combination chemotherapy, the study of AK119 and AK112 combined chemotherapy in the fourth and fifth cohorts will be conducted. The fourth and fifth cohorts will include participants with advanced first-line microsatellite stable colorectal cancer who have not received systemic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AK119 20mg/kg+ AK112 20mg/kg | Experimental | Drug: AK119, Drug: AK112Subjects will receive AK119 plus AK112 via intravenously (IV) Q2W, up to 2 years |
| AK119 40mg/kg+ AK112 20mg/kg | Experimental | Drug: AK119, Drug: AK112Subjects will receive AK119 plus AK112 via intravenously (IV) Q2W, up to 2 years |
| AK119 + AK112 20mg/kg +mFOLFOX6 | Experimental | Drug: AK119, Drug: AK112, Drug: Oxaliplatin, Drug: Calcium folinate, Drug: FluorouracilSubjects will receive AK119 and AK112 plus mFOLFOX6 via intravenously (IV)Q2W, up to 12 cycles. Afterward, AK119 and AK112 will continue to be treated up to 2 years. |
| AK119 + AK112 20mg/kg +FOLFIRI | Experimental | Drug: AK119, Drug: AK112, Drug: Irinotecan, Drug: Calcium folinate, Drug: FluorouracilSubjects will receive AK119 and AK112 plus FOLFIRI via intravenously (IV)Q2W, up to 12 cycles. Afterward, AK119 and AK112 will continue to be treated up to 2 years. |
| AK112 20mg/kg | Experimental | Drug: AK112Subjects will receive AK112 via intravenously (IV) Q2W, up to 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be able to understand and voluntarily sign the written informed consent, which must be signed before the specified research procedure required by the research is implemented.
- Age ≥ 18 when signing the informed consent form (ICF), both male and female。
- Microsatellite stable colorectal cancer confirmed by histopathology; Microsatellite stability was defined as the expression of four common MMR proteins (MLH1, MSH2, MSH6 and PMS2) detected by immunohistochemistry, and all four proteins were positive for pMMR. Or PCR method was used to detect sites (BAT25, BAT26, D5S346, D2S123 and D17S250), and the detection results showed that the stability was microsatellite stability or microsatellite low degree instability.
- The first and second cohorts: recurrent or metastatic colorectal cancer that has failed to undergo at least the second-line standard treatment in the past; The chemotherapy of at least one of the treatment lines is the combination chemotherapy of at least two cytotoxic drugs based on platinum or irinotecan; Definition of treatment failure: disease progression occurs during or after treatment. All patients who change the treatment plan due to drug intolerance are not considered as treatment failure; For subjects who have received induction chemotherapy, concurrent radiotherapy and chemotherapy or adjuvant chemotherapy in the past, if relapse/metastasis occurs within 6 months after the last treatment, the original treatment plan is defined as the first-line treatment plan for the subject.
- The third and fourth cohorts: for patients with advanced colorectal cancer who have not undergone systematic treatment, the recurrence time should be at least 6 months from the end of the last treatment for those who have previously received induction chemotherapy, concurrent radiotherapy and chemotherapy or adjuvant/neoadjuvant chemotherapy.
Key exclusion criteria (8 listed)
- Pathological examination confirmed other pathological types, such as squamous cell carcinoma, sarcoma or undifferentiated carcinoma, gastrointestinal stromal tumor, etc.
- Palliative local treatment for non-target lesions within 2 weeks before the first administration; Have received systemic non-specific immunomodulation therapy (such as interleukin, interferon, thymosin, etc.) within 2 weeks before the first administration; Received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications within 2 weeks before the first administration。
- Had been treated with anti-CD73 inhibitors, immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (such as antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), immune cell therapy (such as CAR-T) and other therapies aimed at tumor immune mechanism.
- There is a history of gastrointestinal perforation and fistula within 6 months before the first administration. If the perforation or fistula has been removed or repaired, and the researcher judges that the disease has recovered or alleviated, it can be admitted into the group.
- Active or inactive Inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) previously recorded. Inability to swallow, malabsorption syndrome, or uncontrollable nausea, vomiting, diarrhea or other gastrointestinal diseases that seriously affect the use and absorption of drugs.
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 |
|---|---|---|
| AK119AK119 IV every 2 weeks.intravenous infusion | Drug | AK119 + AK112 20mg/kg +FOLFIRI, AK119 + AK112 20mg/kg +mFOLFOX6, AK119 20mg/kg+ AK112 20mg/kg, AK119 40mg/kg+ AK112 20mg/kg |
| AK112AK112 IV every 2 weeks.intravenous infusion | Drug | AK112 20mg/kg, AK119 + AK112 20mg/kg +FOLFIRI, AK119 + AK112 20mg/kg +mFOLFOX6, AK119 20mg/kg+ AK112 20mg/kg, AK119 40mg/kg+ AK112 20mg/kg |
| OxaliplatinOxaliplatin: 85mg/m2, intravenous infusion | Drug | AK119 + AK112 20mg/kg +mFOLFOX6 |
| IrinotecanIrinotecan 180mg/m2, intravenous infusion | Drug | AK119 + AK112 20mg/kg +FOLFIRI |
| Calcium folinateCalcium folinate: 400mg/m2, intravenous infusion | Drug | AK119 + AK112 20mg/kg +FOLFIRI, AK119 + AK112 20mg/kg +mFOLFOX6 |
| FluorouracilFluorouracil 400mg/m2, intravenous injection | Drug | AK119 + AK112 20mg/kg +FOLFIRI, AK119 + AK112 20mg/kg +mFOLFOX6 |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 2 years
ORR is defined as the proportion of subjects with confirmed CR or confirmed PR
Number of subjects with adverse events (AEs)
Time frame: From the time of informed consent signed through 90 days after the last dose of study drug
AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
recommended phaseII dose
Time frame: 1 year
Phase II clinical study recommended dose (RP2D) of AK119 and AK112 combined with or without chemotherapy
8 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Duration of response (DoR)
Time frame: Up to 2 years
Time to response (TTR)
Time frame: Up to 2 years
Total survival time (OS) and 12-month OS rate
Time frame: Up to 2 years
Maximum observed concentration (Cmax) of AK119 and AK112
Time frame: From first dose of study drug through last dose up to 100 weeks
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of study drug through last dose up to 100 weeks
Correlation between biomarkers and efficacy
Time frame: Up to 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 4 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Yanqiao Zhang, PhD study chair
Cancer Hospital Affiliated to Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AK119, AK112 and Oxaliplatin in people with Colorectal Cancer, run by Akeso at 1 site in China.
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 9 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 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 rate (ORR) (time frame: Up to 2 years). The study lists 3 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 4 Mar 2026.