Metastatic Colorectal Cancer (CRC)Phase 2NCT07446387
A Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX/mCAPIRI Regimen as First-line Treatment for Unresectable Advanced Colorectal Cancer
A Phase 2 study testing Iparomlimab and tuvonralimab in people with Metastatic Colorectal Cancer (CRC), run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial summary
This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX/mCAPIRI regimen as first-line treatment for unresectable advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer (CRC)
- What is being tested?
- Iparomlimab and tuvonralimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2026to 31 Dec 2029
- 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
- 1. Age 18-75 years;
- 2. Patients with histologically or cytologically confirmed unresectable, advanced colorectal cancer;
- 3. No prior systemic treatment;
- 4. ECOG PS score ≤2;
- 5. Expected survival ≥3 months;
- 6. MSS/MSI-L status;
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- 7. At least one evaluable lesion based on RECIST 1.1 criteria;
- 8. No prior systemic chemotherapy or other systemic therapy, or only received adjuvant chemotherapy with disease progression or recurrence within 6 months after completion of treatment;
- 9. Adequate organ function reserve, with specific hepatic, renal, and hematologic parameters as follows:
- White blood cell count ≥3.5×10⁹/L
- Absolute neutrophil count ≥1.5×10⁹/L
- Hemoglobin ≥100 g/L
- Platelets ≥80×10⁹/L
- Serum liver enzymes ≤2.5× upper limit of normal (ULN) in patients without liver metastases
- Serum liver enzymes ≤5× ULN in patients with liver metastases
- Serum bilirubin ≤1.5× ULN
- Serum creatinine ≤1.5× ULN
- 10. No history of other malignancies;
- 11. Voluntary participation in this study with signed informed consent.
Who cannot join
- 1. Prior hypersensitivity to any of the study drugs;
- 2. Active or known or suspected autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;
- 3. Presence of non-measurable lesions (e.g., pleural effusion/ascites, carcinomatous lymphangitis, diffuse liver involvement, bone metastases);
- 4. Pregnant or lactating women;
- 5. Uncontrolled symptomatic brain metastases or psychiatric disorders preventing accurate expression of subjective symptoms;
- 6. Vital organ function failure;
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- 7. Conditions affecting drug absorption/distribution/metabolism/excretion (e.g., seizures, central nervous system diseases, cognitive impairment due to psychiatric disorders, chronic diarrhea, cachexia, etc.);
- 8. Patients with complete or incomplete intestinal obstruction;
- 9. History of severe cardiac disease (including congestive heart failure, uncontrolled high-risk arrhythmia, angina requiring medication, definite valvular heart disease history, severe myocardial infarction, refractory hypertension);
- 10. Active infection requiring systemic treatment;
- 11. Known history of HIV infection;
- 12. Known history of hepatitis B or active hepatitis C virus infection;
- 13. Other conditions deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Liangjun Zhu, 13505199123, zhulj98@foxmail.com
About this study
Official title: A Prospective, Single-arm, Multicenter Phase II Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX/mCAPIRI Regimen as First-line Treatment for Unresectable Advanced Colorectal Cancer
This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX/mCAPIRI regimen as first-line treatment for unresectable advanced colorectal cancer. The study plans to enroll 70 patients with unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX/mCAPIRI regimen. The primary endpoint of the study is ORR, and secondary endpoints include PFS, DoR, OS, and safety.
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Being tested
- Iparomlimab and tuvonralimab
- Keywords
- mCRC, bevacizumab, QL1706, Combination therapy, Alternating chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and tuvonralimabDrug
Induction Phase: Iparomlimab and tuvonralimab (5 mg/kg, Q3W, D1) + bevacizumab (7.5 mg/kg, Q3W, D1) + CAPOX regimen (oxaliplatin 130 mg/m², Q3W, D1; capecitabine 1,000 mg/m², BID, D1-14, Q3W) / mCAPIRI (irinotecan 180 mg/m², Q3W, D1; capecitabine 800 mg/m², BID, D1-14, Q3W) alternating every 42 days, assessed every 6 weeks, for a maximum of 6 cycles.
Maintenance Phase: Iparomlimab and tuvonralimab 5 mg/kg, Q3W, D1 + bevacizumab 7.5 mg/kg, Q3W, D1 + capecitabine 800-1,000 mg/m², BID, D1, Q3W. Patients with CR/PR/NED or SD are allowed to receive maintenance therapy until disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| QL1706+ bevacizumab+chemotherapy | Experimental | The study consists of a 6-cycle induction treatment phase and a maintenance treatment phase. During the induction phase, patients receive iparomlimab and tuvonralimab combined with bevacizumab and chemotherapy. During the maintenance phase, patients receive iparomlimab and tuvonralimab combined with bevacizumab and capecitabine until disease progression or intolerable toxicity. Receives: Drug: Iparomlimab and tuvonralimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed Objective Response Rate（ORR）
CR+PR
Measured: From enrollment to the end of treatment at 18 months
Secondary outcomes (4)
Investigator-assessed Progression-Free Survival（PFS）
The time from the start of treatment in cancer patients to the observation of disease progression or death from any cause
Measured: From enrollment to the end of treatment at 18 months
Investigator-assessed Duration of Response（DoR）
The time from the first assessment of complete response or partial response to the first assessment of tumor progression or death from any cause
Measured: From enrollment to the end of treatment at 18 months
Overall Survival（OS）
Time from enrollment to death from any cause
Measured: From enrollment to the end of treatment at 36 months
AE
safety
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start30 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liangjun Zhu M.M., Jiangsu Cancer Institute & Hospital
- Investigators
- Liangjun Zhu, Dr, Principal investigator, Jiangu Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446387
- Sponsor's protocol ID
- KY-2025-177
- Status last verified
- May 2026
- First submitted
- 26 Feb 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multicenter Phase II Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX/mCAPIRI Regimen as First-line Treatment for Unresectable Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07446387
- Acronym / sponsor ID
- KY-2025-177
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Keywords
- mCRC, bevacizumab, QL1706, Combination therapy, Alternating chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Mar 2026 (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 study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX/mCAPIRI regimen as first-line treatment for unresectable advanced colorectal cancer. The study plans to enroll 70 patients with unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX/mCAPIRI regimen. The primary endpoint of the study is ORR, and secondary endpoints include PFS, DoR, OS, and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1706+ bevacizumab+chemotherapy | Experimental | Drug: Iparomlimab and tuvonralimabThe study consists of a 6-cycle induction treatment phase and a maintenance treatment phase. During the induction phase, patients receive iparomlimab and tuvonralimab combined with bevacizumab and chemotherapy. During the maintenance phase, patients receive iparomlimab and tuvonralimab combined with bevacizumab and capecitabine until disease progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 1. Age 18-75 years;
- 2. Patients with histologically or cytologically confirmed unresectable, advanced colorectal cancer;
- 3. No prior systemic treatment;
- 4. ECOG PS score ≤2;
- 5. Expected survival ≥3 months;
Key exclusion criteria (13 listed)
- 1. Prior hypersensitivity to any of the study drugs;
- 2. Active or known or suspected autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;
- 3. Presence of non-measurable lesions (e.g., pleural effusion/ascites, carcinomatous lymphangitis, diffuse liver involvement, bone metastases);
- 4. Pregnant or lactating women;
- 5. Uncontrolled symptomatic brain metastases or psychiatric disorders preventing accurate expression of subjective symptoms;
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 |
|---|---|---|
| Iparomlimab and tuvonralimabInduction Phase: Iparomlimab and tuvonralimab (5 mg/kg, Q3W, D1) + bevacizumab (7.5 mg/kg, Q3W, D1) + CAPOX regimen (oxaliplatin 130 mg/m², Q3W, D1; capecitabine 1,000 mg/m², BID, D1-14, Q3W) / mCAPIRI (irinotecan 180 mg/m², Q3W, D1; capecitabine 800 mg/m², BID, D1-14, Q3W) alternating every 42 days, assessed every 6 weeks, for a maximum of 6 cycles. Maintenance Phase: Iparomlimab and tuvonralimab 5 mg/kg, Q3W, D1 + bevacizumab 7.5 mg/kg, Q3W, D1 + capecitabine 800-1,000 mg/m², BID, D1, Q3W. Patients with CR/PR/NED or SD are allowed to receive maintenance therapy until disease progression or intolerable toxicity. | Drug | QL1706+ bevacizumab+chemotherapy |
Primary outcome
Investigator-assessed Objective Response Rate（ORR）
Time frame: From enrollment to the end of treatment at 18 months
CR+PR
4 secondary outcomes
Investigator-assessed Progression-Free Survival（PFS）
Time frame: From enrollment to the end of treatment at 18 months
Investigator-assessed Duration of Response（DoR）
Time frame: From enrollment to the end of treatment at 18 months
Overall Survival（OS）
Time frame: From enrollment to the end of treatment at 36 months
AE
Time frame: From enrollment to the end of treatment at 12 weeks
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 12 May 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.
Liangjun Zhu, Dr principal investigator
Jiangu Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and tuvonralimab in people with Metastatic Colorectal Cancer (CRC), run by Jiangsu Cancer Institute & Hospital 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 19 inclusion and 13 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: opening soon, as of the sponsor's last update on 12 May 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 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?
Contact Liangjun Zhu (13505199123, zhulj98@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed Objective Response Rate（ORR） (time frame: From enrollment to the end of treatment at 18 months). 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 12 May 2026.