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Malignant MesotheliomaPhase 1/2NCT07131345

Study of Iparomlimab and Tuvonralimab Plus Chemotherapy in Malignant Mesothelioma

A Phase 1/2 study testing iparomlimab and tuvonralimab (Dual PD-1/CTLA-4 blockade) + chemotherapy in people with Malignant Mesothelioma and Mesothelioma, run by National Cancer Center, 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
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Trial summary

This clinical trial aims to investigate the effectiveness and safety of a new treatment combination-Iparomlimab and Tuvonralimab (QL1706, a dual-function antibody targeting PD-1 and CTLA-4) combined with chemotherapy-for patients with malignant mesothelioma (MM). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Mesothelioma, Mesothelioma
What is being tested?
iparomlimab and tuvonralimab (Dual PD-1/CTLA-4 blockade) + chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
No sites listed yet
Study dates
1 Sep 2025to 1 Jul 2027
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must provide informed consent prior to initiating any study-specific procedures.
  • Male or female subjects aged ≥18 and ≤75 years.
  • Histologically/cytologically confirmed malignant mesothelioma (MM), including malignant pleural mesothelioma (PM) and malignant peritoneal mesothelioma (PeM).
  • Subjects with MM unsuitable for radical resection and/or radiotherapy per AJCC 8th Edition.
  • Subjects who received neoadjuvant/adjuvant chemotherapy for radical surgery completed >6 months prior to current recurrent disease diagnosis, not counted in subsequent treatment lines.
  • Prior systemic anti-tumor therapy requirements:
Show all 12Show fewer
  • Safety run-in phase: ≥1 prior anti-tumor therapy line (maximum 3 lines)
  • Phase II first-line cohort: No prior systemic anti-tumor therapy
  • Phase II second-line cohort: Only 1 prior systemic anti-tumor therapy line
  • ECOG performance status 0-2.
  • Investigator-assessed life expectancy >3 months.
  • Adequate hematological parameters.

Who cannot join

  • Prior CTLA-4 inhibitors prohibited; prior PD-1/PD-L1 allowed unless discontinued for immune toxicity
  • Immunomodulators within 14 days (e.g., thymosin, interleukin-2, interferon)
  • Significant cardiovascular history within 6 months

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Puyuan Xing, MD contact

8618611417207

xingpuyuan@cicams.ac.cn

About this study

Official title: A Single-Arm, Multicenter, Open-Label Phase Ib/II Clinical Study Exploring the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy for the Treatment of Malignant Mesothelioma

This clinical trial aims to investigate the effectiveness and safety of a new treatment combination-Iparomlimab and Tuvonralimab (QL1706, a dual-function antibody targeting PD-1 and CTLA-4) combined with chemotherapy-for patients with malignant mesothelioma (MM). MM is a rare and aggressive cancer often linked to asbestos exposure. Current treatments have limited success, and this study seeks to explore a potentially more effective and safer option.

Study Design:

Read more

Phase Ib (Safety Phase): 6 patients will receive the combination therapy to assess safety. If no major safety issues arise, the study will proceed to Phase II.

Phase II (Efficacy Phase): 49 patients will be enrolled to evaluate treatment effectiveness. The study includes two groups for first-line treatment and second-line treatment.

Read the detailed description

Study Rationale Malignant mesothelioma (MM) is a rare and aggressive cancer primarily associated with asbestos exposure. Despite advances in treatment, the prognosis remains poor, with a median overall survival (OS) of approximately 12-18 months for advanced disease. Current standard therapies include platinum-based chemotherapy combined with pemetrexed, immune checkpoint inhibitors (ICIs) such as nivolumab plus ipilimumab, or pembrolizumab with chemotherapy. However, these treatments have limitations, including significant toxicity (e.g., immune-related adverse events, irAEs) and modest survival benefits in certain populations.

The iparomlimab and tuvonralimab (QL1706) combination is a novel bispecific antibody therapy targeting PD-1 and CTLA-4, designed to enhance anti-tumor immune responses while minimizing toxicity. Preclinical and early clinical data suggest this dual checkpoint blockade may offer comparable efficacy to existing ICI combinations but with an improved safety profile. Given the unmet need for effective and tolerable therapies in MM, this study evaluates the clinical potential of iparomlimab and tuvonralimab combined with chemotherapy in Chinese patients.

Study Design

This is a single-arm, multicenter, open-label Ib/II trial with two sequential phases:

Phase Ib (Safety Run-In, n=6):

Evaluates the safety of iparomlimab and tuvonralimab + chemotherapy in patients with 1-3 prior lines of therapy.

Phase II (Expansion, n=49):

First-line cohort (n=39): Patients receive iparomlimab and tuvonralimab + pemetrexed/platinum (Simon two-stage design).

Second-line cohort (n=10): Fixed-sample evaluation of iparomlimab and tuvonralimab + investigator-selected chemotherapy.

Treatment Regimen

Induction Phase (4-6 cycles, Q3W):

Iparomlimab and tuvonralimab (5 mg/kg IV, Day 1)

Chemotherapy backbone:

First-line: Pemetrexed (500 mg/m²) + cisplatin (75 mg/m²) or carboplatin (AUC 5).

Second-line: Investigator's choice (pemetrexed, gemcitabine, or vinorelbine).

Maintenance Phase (up to 2 years, Q3W):

Iparomlimab and tuvonralimab monotherapy (5 mg/kg) until progression or unacceptable toxicity.

Being tested
iparomlimab and tuvonralimab (Dual PD-1/CTLA-4 blockade) + chemotherapy
Keywords
Malignant Mesothelioma, iparomlimab and tuvonralimab, immunotherapy
Medical subject headings
Mesothelioma, Malignant, Mesothelioma

What participants receive

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

  • iparomlimab and tuvonralimab (Dual PD-1/CTLA-4 blockade) + chemotherapyDrug

    Also called QL1706+chemotherapy

    Novel Bispecific Checkpoint Inhibition:

    QL1706(iparomlimab and Tuvonralimab) was generated by using MabPair, a new technological platform that enables the production of two antibodies close to their natural forms from a single host cell line and is manufactured as one product. QL1706 contains a mixture of anti-PD-1 IgG4 and anti-CTLA-4 IgG1 that were produced together in a fixed ratio. Each antibody was individually optimized to achieve desirable target coverage and antibody effector functions.

    Chemotherapy for first-line treatment (pemetrexed plus cisplatin or carboplatin )

    Chemotherapy for second-line treatment (pemetrexed, gemcitabine or vinorelbine)

Study groups in NCT07131345
Study groupRoleWhat they receive
Arm: Iparomlimab and Tuvonralimab Combined with ChemotherapyExperimentalPatients will receive Iparomlimab and Tuvonralimab (5 mg/kg) plus chemotherapy (pemetrexed and platinum drugs) every 3 weeks for 4-6 cycles, followed by maintenance therapy with Iparomlimab and Tuvonralimab for up to 2 years.
Receives: Drug: iparomlimab and tuvonralimab (Dual PD-1/CTLA-4 blockade) + chemotherapy

What is being measured

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

  1. ORR

    Objective Response Rate，Proportion of participants achieving complete response (CR) or partial response (PR) per modified RECIST 1.1 for mesothelioma

    Measured: From enrollment to the end of treatment at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion1 Jul 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07131345
Sponsor's protocol ID
NCC5281
Status last verified
Aug 2025
First submitted
14 Jun 2025
Last updated
20 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing iparomlimab and tuvonralimab (Dual PD-1/CTLA-4 blockade) + chemotherapy in people with Malignant Mesothelioma and Mesothelioma, run by National Cancer Center, 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 3 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 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Puyuan Xing, MD (8618611417207, xingpuyuan@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: From enrollment to the end of treatment at 8 weeks). 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 NCT07131345.

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 20 Aug 2025.

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