Study of Iparomlimab and Tuvonralimab Plus Chemotherapy in Malignant Mesothelioma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNational Cancer Center, China
About this trial
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:
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
iparomlimab and tuvonralimab (Dual PD-1/CTLA-4 blockade) + chemotherapy
DrugNovel 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)
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Arm: Iparomlimab and Tuvonralimab Combined with ChemotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR
Objective Response Rate，Proportion of participants achieving complete response (CR) or partial response (PR) per modified RECIST 1.1 for mesothelioma
Time frame
From enrollment to the end of treatment at 8 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cancer Center, China
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Collaborator
Affiliated Cancer Hospital of Zhengzhou University
Collaborator
Beijing Chest Hospital, Capital Medical University
Collaborator
The Affiliated Hospital of Inner Mongolia Medical University
Collaborator
Shaanxi Provincial Cancer Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: