Colorectal CancerNCT07874438
A Prospective, Single-Arm, Multicenter, Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Cetuximab and mFOLFIRI Regimen as First-Line Treatment for Recurrent or Metastatic Colorectal Cancer
A study testing QL1706 combined with cetuximab and mFOLFIRI in people with Colorectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is a prospective, single-arm, multicenter, phase II clinical study designed to evaluate the efficacy and safety of iparomlimab and tuvonralimab (QL1706) combined with cetuximab and mFOLFIRI as first-line treatment for recurrent or metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- QL1706 combined with cetuximab and mFOLFIRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2026to 31 Dec 2029
- Phase
- Interventional
- 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. Participants voluntarily agree to participate in this study, sign the informed consent form, and strictly comply with the study protocol requirements.
- 2. Age ≥18 years and ≤75 years at enrollment, male or female.
- 3. Histopathologically confirmed recurrent or metastatic colorectal adenocarcinoma; the enrolled population must have low-level microsatellite instability (MSI-L) or microsatellite stable (MSS)/mismatch repair-proficient (pMMR) tumors and be RAS and BRAF wild-type.
- 4. At least one measurable tumor lesion per RECIST v1.1.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 6. Expected survival ≥3 months.
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- 7. Recovered from toxicities related to prior therapy before study enrollment.
- 8. Adequate vital organ function as follows: Hematology: absolute neutrophil count (ANC) ≥1.5 × 10^9/L, platelet count (PLT) ≥90 × 10^9/L, hemoglobin (Hb) ≥90 g/L. Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN); for participants with liver metastases, AST and ALT ≤5 × ULN; serum total bilirubin (TBIL) ≤1.5 × ULN (for participants with Gilbert's syndrome, TBIL <3 × ULN); albumin (ALB) ≥30 g/L. Thyroid function: thyroid-stimulating hormone (TSH) ≤1 × ULN (if abnormal, free triiodothyronine [FT3] and free thyroxine [FT4] levels should also be assessed; participants with normal FT3 and FT4 may be enrolled). Coagulation function: activated partial thromboplastin time (APTT) ≤1.5 × ULN, international normalized ratio (INR) ≤1.5, prothrombin time (PT) ≤1.5 × ULN. Urine protein: qualitative urine protein ≤1+ (if ≥2+, a 24-hour urine protein test is required; if the result is <1 g, enrollment is permitted). Cardiac left ventricular ejection fraction (LVEF) ≥50%.
- 9. Participants of childbearing potential must use adequate contraception during the study and for 120 days after study completion; female participants must have a negative serum pregnancy test within 7 days before study enrollment and must not be breastfeeding.
Who cannot join
- 1. Radiotherapy or surgery within 30 days before initiation of study treatment (except prior diagnostic biopsy).
- 2. Prior adjuvant chemotherapy for colorectal cancer (CRC), with an interval of less than 12 months between the end of adjuvant chemotherapy and the detection of disease recurrence or metastasis.
- 3. Prior treatment with anti-EGFR monoclonal antibodies, EGFR tyrosine kinase inhibitors, or other EGFR-targeted therapies (e.g., cetuximab, nimotuzumab, panitumumab).
- 4. Known hypersensitivity or anaphylactic reaction to any component of the study treatment.
- 5. History of organ transplantation or autologous/allogeneic stem cell transplantation.
- 6. History of other malignancies other than CRC within the past 5 years, except cured carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin.
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- 7. Other concomitant antitumor therapy.
- 8. Symptomatic brain and/or leptomeningeal metastases.
- 9. Participation in any investigational drug treatment or use of an investigational device within 4 weeks before first dose.
- 10. Currently receiving chronic systemic immunotherapy or hormonal therapy other than physiologic replacement therapy.
- 11. Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, angina that began within the last 3 months, congestive heart failure (New York Heart Association [NYHA] class ≥ II), myocardial infarction within 6 months before enrollment, severe arrhythmia requiring medical treatment, or hepatic, renal, or metabolic disease.
- 12. Acute or subacute intestinal obstruction, or a history of inflammatory bowel disease.
- 13. Participants with severe bone marrow failure.
- 14. Any disease, metabolic disorder, or physical examination or laboratory finding that suggests a contraindication to the study drug or a high risk of treatment complications.
- 15. Known or self-reported human immunodeficiency virus (HIV) infection.
- 16. HBV-DNA positive (viral load >10^3 copies/mL).
- 17. Pregnancy or lactation.
- 18. Prior treatment with any therapy targeting tumor immune mechanisms, including immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., antibodies targeting ICOS, CD40, CD137, GITR, or OX40), or immune cell therapy.
- 19. Received a live vaccine within 4 weeks before first dose, or plans to receive a live vaccine during the study.
- 20. Any condition that, in the investigator's opinion, may make it risky to receive the study drug, or may interfere with the evaluation of the study drug, participant safety, or interpretation of study results.
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
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Zan Fu, 13338603209, fuzan1971@njmu.edu.cn
Jing Sun, 13914704178, sunj@njmu.edu.cn
About this study
This is a prospective, single-arm, multicenter, phase II clinical study designed to evaluate the efficacy and safety of iparomlimab and tuvonralimab (QL1706) combined with cetuximab and mFOLFIRI as first-line treatment for recurrent or metastatic colorectal cancer. A total of 55 participants with low-level microsatellite instability (MSI-L) or microsatellite stable (MSS)/mismatch repair-proficient (pMMR) and RAS/BRAF wild-type tumors will be enrolled. Enrolled participants will receive iparomlimab and tuvonralimab (5 mg/kg, Q3W, Day 1) + cetuximab (500 mg/m², Q2W, Day 1) + irinotecan (180 mg/m², Q2W, Day 1) + leucovorin (LV) (400 mg/m², Q2W, Day 1) + 5-FU (400 mg/m², Q2W, Day 1). After 12 cycles of the chemotherapy phase, participants who achieve CR, PR, or SD will then receive maintenance therapy with iparomlimab and tuvonralimab (5 mg/kg, Q3W, Day 1) + cetuximab (500 mg/m², Q2W, Day 1) + leucovorin (LV) (400 mg/m², Q2W, Day 1) + 5-fluorouracil (5-FU) (400 mg/m², Q2W, Day 1) until disease progression, intolerable toxicity, investigator determination that the participant is no longer benefiting, withdrawal of informed consent, completion of 2 years of iparomlimab and tuvonralimab treatment, or other protocol-specified reasons.
- Conditions
- Colorectal Cancer
- Being tested
- QL1706 combined with cetuximab and mFOLFIRI
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706 combined with cetuximab and mFOLFIRIDrug
QL1706 (5 mg/kg, Q3W, Day 1) + cetuximab (500 mg/m², Q2W, Day 1) + irinotecan (180 mg/m², Q2W, Day 1) + leucovorin (LV) (400 mg/m², Q2W, Day 1) + 5-FU (400 mg/m², Q2W, Day 1). After 12 cycles of the chemotherapy phase, participants who achieve CR, PR, or SD will then receive maintenance therapy with iparomlimab and tuvonralimab (5 mg/kg, Q3W, Day 1) + cetuximab (500 mg/m², Q2W, Day 1) + leucovorin (LV) (400 mg/m², Q2W, Day 1) + 5-fluorouracil (5-FU) (400 mg/m², Q2W, Day 1)
| Study group | Role | What they receive |
|---|---|---|
| QL1706 | Experimental | Not described Receives: Drug: QL1706 combined with cetuximab and mFOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from enrollment/randomization/first dose to the first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first. Participants without a PFS event will be censored at the date of the last tumor assessment.
Measured: From first dose until documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first (up to approximately 24 months)
Secondary outcomes (5)
Objective Response Rate (ORR) Assessed by Investigators per RECIST v1.1
Objective response rate (ORR) is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST v1.1.
Measured: From first dose until documented disease progression, initiation of new anticancer therapy, death, or data cutoff, whichever occurs first (up to approximately 24 months).
Disease Control Rate (DCR) Assessed by Investigators per RECIST v1.1
Disease control rate (DCR) is defined as the proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to RECIST v1.1.
Measured: From first dose until documented disease progression, initiation of new anticancer therapy, death, or data cutoff, whichever occurs first (up to approximately 24 months).
Duration of Response (DoR) Assessed by Investigators per RECIST v1.1
Duration of response (DoR) was defined as the time from the first documentation of objective response (complete response [CR] or partial response [PR]) to the first documentation of disease progression per RECIST v1.1 or death from any cause, whichever occurred first, in participants who achieved a confirmed CR or PR as assessed by the investigator. Participants without an event were censored at the date of the last tumor assessment.
Measured: From first documentation of objective response (CR or PR) to documented disease progression per RECIST v1.1, death from any cause, or data cutoff, whichever occurs first (up to approximately 24 months).
12-Month and 24-Month Overall Survival Rates
The proportion of participants who were alive at 12 months and 24 months after the first dose, estimated using the Kaplan-Meier method. Participants who had not died or were lost to follow-up at the data cutoff were censored at the date last known alive.
Measured: 12 and 24 months after first dose
Overall Survival (OS)
Overall survival (OS) is defined as the time from first dose (or enrollment/randomization, as specified in the protocol) to death from any cause. Participants who are alive or lost to follow-up at the data cutoff will be censored at the date last known alive.
Measured: From first dose to death from any cause or data cutoff (up to approximately 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start8 Oct 2026 (estimated)
- Primary completion30 Jun 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 Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874438
- Sponsor's protocol ID
- QL-CRC-QIBA-3003
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 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 14 Oct 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 (QL1706) Combined With Cetuximab and mFOLFIRI Regimen as First-Line Treatment for Recurrent or Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07874438
- Acronym / sponsor ID
- QL-CRC-QIBA-3003
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 Oct 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 is a prospective, single-arm, multicenter, phase II clinical study designed to evaluate the efficacy and safety of iparomlimab and tuvonralimab (QL1706) combined with cetuximab and mFOLFIRI as first-line treatment for recurrent or metastatic colorectal cancer. A total of 55 participants with low-level microsatellite instability (MSI-L) or microsatellite stable (MSS)/mismatch repair-proficient (pMMR) and RAS/BRAF wild-type tumors will be enrolled. Enrolled participants will receive iparomlimab and tuvonralimab (5 mg/kg, Q3W, Day 1) + cetuximab (500 mg/m², Q2W, Day 1) + irinotecan (180 mg/m², Q2W, Day 1) + leucovorin (LV) (400 mg/m², Q2W, Day 1) + 5-FU (400 mg/m², Q2W, Day 1). After 12 cycles of the chemotherapy phase, participants who achieve CR, PR, or SD will then receive maintenance therapy with iparomlimab and tuvonralimab (5 mg/kg, Q3W, Day 1) + cetuximab (500 mg/m², Q2W, Day 1) + leucovorin (LV) (400 mg/m², Q2W, Day 1) + 5-fluorouracil (5-FU) (400 mg/m², Q2W, Day 1) until disease progression, intolerable toxicity, investigator determination that the participant is no longer benefiting, withdrawal of informed consent, completion of 2 years of iparomlimab and tuvonralimab treatment, or other protocol-specified reasons.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1706 | Experimental | Drug: QL1706 combined with cetuximab and mFOLFIRI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Participants voluntarily agree to participate in this study, sign the informed consent form, and strictly comply with the study protocol requirements.
- 2. Age ≥18 years and ≤75 years at enrollment, male or female.
- 3. Histopathologically confirmed recurrent or metastatic colorectal adenocarcinoma; the enrolled population must have low-level microsatellite instability (MSI-L) or microsatellite stable (MSS)/mismatch repair-proficient (pMMR) tumors and be RAS and BRAF wild-type.
- 4. At least one measurable tumor lesion per RECIST v1.1.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (20 listed)
- 1. Radiotherapy or surgery within 30 days before initiation of study treatment (except prior diagnostic biopsy).
- 2. Prior adjuvant chemotherapy for colorectal cancer (CRC), with an interval of less than 12 months between the end of adjuvant chemotherapy and the detection of disease recurrence or metastasis.
- 3. Prior treatment with anti-EGFR monoclonal antibodies, EGFR tyrosine kinase inhibitors, or other EGFR-targeted therapies (e.g., cetuximab, nimotuzumab, panitumumab).
- 4. Known hypersensitivity or anaphylactic reaction to any component of the study treatment.
- 5. History of organ transplantation or autologous/allogeneic stem cell transplantation.
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 |
|---|---|---|
| QL1706 combined with cetuximab and mFOLFIRIQL1706 (5 mg/kg, Q3W, Day 1) + cetuximab (500 mg/m², Q2W, Day 1) + irinotecan (180 mg/m², Q2W, Day 1) + leucovorin (LV) (400 mg/m², Q2W, Day 1) + 5-FU (400 mg/m², Q2W, Day 1). After 12 cycles of the chemotherapy phase, participants who achieve CR, PR, or SD will then receive maintenance therapy with iparomlimab and tuvonralimab (5 mg/kg, Q3W, Day 1) + cetuximab (500 mg/m², Q2W, Day 1) + leucovorin (LV) (400 mg/m², Q2W, Day 1) + 5-fluorouracil (5-FU) (400 mg/m², Q2W, Day 1) | Drug | QL1706 |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From first dose until documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first (up to approximately 24 months)
Progression-free survival (PFS) is defined as the time from enrollment/randomization/first dose to the first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first. Participants without a PFS event will be censored at the date of the last tumor assessment.
5 secondary outcomes
Objective Response Rate (ORR) Assessed by Investigators per RECIST v1.1
Time frame: From first dose until documented disease progression, initiation of new anticancer therapy, death, or data cutoff, whichever occurs first (up to approximately 24 months).
Disease Control Rate (DCR) Assessed by Investigators per RECIST v1.1
Time frame: From first dose until documented disease progression, initiation of new anticancer therapy, death, or data cutoff, whichever occurs first (up to approximately 24 months).
Duration of Response (DoR) Assessed by Investigators per RECIST v1.1
Time frame: From first documentation of objective response (CR or PR) to documented disease progression per RECIST v1.1, death from any cause, or data cutoff, whichever occurs first (up to approximately 24 months).
12-Month and 24-Month Overall Survival Rates
Time frame: 12 and 24 months after first dose
Overall Survival (OS)
Time frame: From first dose to death from any cause or data cutoff (up to approximately 24 months).
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 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QL1706 combined with cetuximab and mFOLFIRI in people with Colorectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University 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 20 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 14 Oct 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.
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 Zan Fu (13338603209, fuzan1971@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From first dose until documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first (up to approximately 24 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 14 Oct 2026.