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Unresectable Colorectal CancerPhase 2NCT07009145

QL1706 Plus Bevacizumab for Unresectable or Metastatic MSI-H/dMMR CRC

A Phase 2 study testing QL1706 and Bevacizumab in people with Unresectable Colorectal Cancer and Metastatic Colorectal Cancer (CRC), run by Qianfoshan Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single-arm, multi-center, exploratory study evaluating the efficacy and safety of iparomlimab and tuvonralimab (QL1706) in combination with bevacizumab for the treatment of patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) unresectable or metastatic colorectal cancer. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
QL1706 and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
27 Jun 2025to 31 Dec 2027
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily signs the informed consent form.
  • Aged between 18 and 80 years (inclusive) at the time of consent; no gender restriction.
  • Histologically confirmed unresectable locally advanced or metastatic colorectal cancer.
  • At least one measurable target lesion according to RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • No prior immunotherapy for unresectable locally advanced or metastatic colorectal cancer.
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  • If previously treated with standard neoadjuvant or adjuvant therapy, the interval from the last dose to the first study treatment must be ≥ 6 months.
  • Willing and able to provide tumor tissue and blood samples for MSI, RAS, BRAF, and PD-L1 testing.
  • Estimated life expectancy of ≥ 12 months.
  • Appropriate laboratory values must be met at screening.
  • Female participants must be non-lactating, and have a negative pregnancy test result prior to enrollment.
  • Participants of childbearing potential must agree to use effective contraception from the time of informed consent until at least 180 days after the last dose of study treatment.

Who cannot join

  • Known history of severe allergic reactions to iparomlimab and tuvonralimab or bevacizumab.
  • Active malignancy other than colorectal cancer within 5 years prior to first treatment.
  • Large tumor lesions, especially those previously irradiated, with signs of bleeding.
  • Imaging showing tumor invasion of major blood vessels (e.g., pulmonary artery or superior vena cava), including encasement or invasion of the vessel lumen.
  • Brain metastases (asymptomatic or treated symptomatic brain metastases stable for >4 weeks allowed).
  • Active autoimmune disease requiring systemic treatment.
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  • Active pulmonary diseases such as tuberculosis, radiation pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction during screening.
  • Requirement for long-term or high-dose NSAIDs (aspirin >325 mg) or anticoagulant therapy.
  • History of severe gastrointestinal events within 6 months prior to first treatment.
  • Severe intestinal obstruction symptoms or signs and unretrieved intestinal stents at screening.
  • Cardiovascular or cerebrovascular diseases including but not limited to: NYHA class > II heart failure; unstable or severe angina; myocardial infarction or stroke within 6 months; atrial fibrillation or other arrhythmias requiring treatment; symptomatic superior vena cava syndrome; prolonged QT interval (male QT > 450 ms; female QTc > 470 ms); uncontrolled hypertension despite medication (SBP >140 mmHg and/or DBP >90 mmHg) or history of hypertensive crisis or encephalopathy.
  • Known bleeding disorders or coagulopathies.
  • Uncontrolled pleural, pericardial, or ascitic effusions requiring drainage.
  • Active infection or unexplained fever >38.5°C at screening (cancer-related fever allowed).
  • Use of systemic broad-spectrum antibiotics within 30 days prior to first treatment.
  • Systemic corticosteroids (>10 mg prednisone equivalent daily) or immunosuppressants within 14 days prior to first treatment, or immunostimulants within 4 weeks.
  • Major surgery, severe fractures, or therapeutic clinical trials within 4 weeks prior to first treatment; herbal treatment within 2 weeks.
  • Ongoing adverse events from prior antitumor therapy greater than grade 1.
  • HIV infection, other congenital or acquired immunodeficiencies, or history of organ or allogeneic bone marrow transplantation (except corneal transplantation).
  • Positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with HBV DNA >10⁴ copies/mL (~2000 IU/mL); or positive hepatitis C antibody with HCV RNA >10³ copies/mL; co-infection with HBV and HCV excluded.
  • Vaccination with live or attenuated vaccines within 30 days prior to first treatment.
  • Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-OX-40, anti-CD137).
  • Prior adjuvant targeted therapy against EGFR, VEGF, or VEGFR (e.g., bevacizumab, cetuximab, panitumumab, apatinib, regorafenib, anlotinib).
  • Psychiatric disorders, epilepsy, dementia, or substance abuse that may affect compliance.
  • Other conditions or lab abnormalities that may interfere with study participation or confound results as judged by investigators or sponsors.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jun Wang, Associate Director, Department of Oncology, MD, PHD contact

0531-82169851

ggjun2005@126.com

China1 site

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong, 250000

    Jun Wang, Associate Director, Department of Oncology, MD, PHD, 0531-89269221, ggjun2005@126.com

Other trials in China

About this study

Official title: An Exploratory Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Bevacizumab for the Treatment of Unresectable or Metastatic MSI-H/dMMR Colorectal Cancer

This is a single-arm, multi-center, exploratory study evaluating the efficacy and safety of iparomlimab and tuvonralimab (QL1706) in combination with bevacizumab for the treatment of patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) unresectable or metastatic colorectal cancer. Eligible participants who meet the inclusion and exclusion criteria will provide written informed consent and receive QL1706 at 5.0 mg/kg and bevacizumab at 7.5 mg/kg on Day 1 of every 3-week cycle (Q3W), until disease progression or completion of 2 years of treatment. The primary endpoint of this study is objective response rate (ORR). Secondary endpoints include disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), PFS and OS rates at 6, 12, and 24 months, and safety.

Being tested
QL1706, Bevacizumab
Keywords
QL1706, CRC, MSI-H/dMMR
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QL1706Drug

    QL1706 (Iparomlimab and Tuvonralimab) is administered at a dose of 5 mg/kg via intravenous infusion on Day 1 of each 3-week cycle (Q3W).

  • BevacizumabDrug

    Bevacizumab is administered at a dose of 7.5 mg/kg every 3 weeks (Q3W) via intravenous (iv) infusion.

Study groups in NCT07009145
Study groupRoleWhat they receive
QL1706 + BevacizumabExperimentalNot described
Receives: Drug: QL1706; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    The proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects

    Measured: approximately 6 months after the last subject participating in

Secondary outcomes (7)

  1. DCR

    The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects

    Measured: approximately 12 months after the last subject participating in

  2. DOR

    The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.

    Measured: approximately 12 months after the last subject participating in

  3. PFS

    The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first (per RECIST 1.1).

    Measured: approximately 12 months after the last subject participating in

  4. 6/12/24 PFS rate

    6/12/24 months survival rate based on PFS Kaplan-Meier curve

    Measured: 6/12/24 months after the last subject participating in

  5. OS

    The time from the starting date of study drug to the date of death due to any cause.

    Measured: approximately 12 months after the last subject participating in

  6. 6/12/24 OS rate

    6/12/24 months survival rate based on OS Kaplan-Meier curve

    Measured: 6/12/24 months after the last subject participating in

  7. Safety (adverse event)

    The rates of adverse events based on NCI CTCAE v5.0

    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.

  1. First posted6 Jun 2025
  2. Study start27 Jun 2025 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07009145
Sponsor's protocol ID
YXLL-KY-2025(092)
Status last verified
May 2025
First submitted
28 May 2025
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QL1706 and Bevacizumab in people with Unresectable Colorectal Cancer and Metastatic Colorectal Cancer (CRC), run by Qianfoshan 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 12 inclusion and 25 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 6 Jun 2025. 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 Jun Wang, Associate Director, Department of Oncology, MD, PHD (0531-82169851, ggjun2005@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: approximately 6 months after the last subject participating in). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07009145.

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 6 Jun 2025.

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