Malignant Pleural Mesothelioma, AdvancedPhase 1/2NCT07885319
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
A Phase 1/2 study testing Ivonescimab Combined With Chemotherapy in people with Malignant Pleural Mesothelioma, Advanced, run by Ruijin Hospital at 3 sites in China.
Trial summary
This Phase 1b/2, open-label, multicenter, single-arm study evaluates the safety and efficacy of ivonescimab in combination with pemetrexed and platinum-based chemotherapy as first-line treatment for advanced malignant pleural mesothelioma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Pleural Mesothelioma, Advanced
- What is being tested?
- Ivonescimab Combined With Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 3 sitesChina
- Study dates
- 1 Nov 2026to 30 Nov 2028
- Phase
- Phase 1/2
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
- Age 18 to 75 years.
- Histologically confirmed advanced or metastatic malignant pleural mesothelioma not amenable to surgery.
- No prior systemic anticancer therapy for advanced disease.
- ECOG PS 0-1.
- At least one measurable lesion according to modified RECIST (mRECIST).
- Adequate organ function for study treatment.
- Patients with asymptomatic or stable brain metastases are eligible.
- Able to understand the study, provide written informed consent, and comply with study procedures.
Who cannot join
- Active autoimmune disease requiring systemic treatment or other contraindications to immunotherapy.
- Uncontrolled hypertension, significant bleeding risk, or other contraindications to antiangiogenic therapy.
- Active interstitial lung disease or noninfectious pneumonitis.
- Active infection requiring systemic treatment.
- Other active malignancies requiring anticancer treatment.
- Severe uncontrolled medical conditions that may interfere with study treatment.
- Pregnant or breastfeeding women.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Dan Li, MD, PhD, +86-28-85422114, lidan@wchscu.cn
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Yi Xiang, MD, PhD, +86-21-64370045, xiangyiht@163.com
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Yuqing Lou, MD, PhD, +86-21-22200000, louyq@hotmail.com
About this study
Official title: A Phase 1b/2, Open-Label, Multicenter, Single-Arm Study of Ivonescimab in Combination With Pemetrexed and Platinum-Based Chemotherapy as First-Line Treatment in Patients With Advanced Malignant Pleural Mesothelioma
This Phase 1b/2, open-label, multicenter, single-arm study evaluates the safety and efficacy of ivonescimab in combination with pemetrexed and platinum-based chemotherapy as first-line treatment for advanced malignant pleural mesothelioma. Phase 1b evaluates the candidate recommended Phase 2 dose (RP2D), followed by Phase 2 evaluation at the confirmed RP2D.
Read the detailed description
In Phase 1b, ivonescimab 20 mg/kg, selected as the candidate RP2D based on prior Phase 1a results, is administered every 3 weeks in combination with pemetrexed 500 mg/m² and cisplatin 75 mg/m² or carboplatin AUC 5 for 4 to 6 cycles. Phase 1b further evaluates safety and preliminary efficacy and confirms the RP2D. In Phase 2, participants receive ivonescimab at the confirmed RP2D with the same chemotherapy regimen, followed by maintenance treatment with ivonescimab with or without pemetrexed every 3 weeks. Objective response rate (ORR) is the primary efficacy endpoint of Phase 2. Peripheral blood, pleural effusion, and pleural tissue samples will be collected for exploratory analyses.
- Conditions
- Malignant Pleural Mesothelioma, Advanced
- Being tested
- Ivonescimab Combined With Chemotherapy
- Keywords
- Ivonescimab, Pemetrexed, Platinum-Based Chemotherapy, Phase 1b/2, First-Line Treatment
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivonescimab Combined With ChemotherapyDrug
In Phase 1b, ivonescimab 20 mg/kg is administered intravenously every 3 weeks (Q3W) in combination with pemetrexed 500 mg/m² and cisplatin 75 mg/m² or carboplatin AUC 5 for 4 to 6 cycles. In Phase 2, ivonescimab is administered at the confirmed RP2D with the same chemotherapy regimen, followed by maintenance treatment with ivonescimab with or without pemetrexed Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy | Experimental | A single experimental arm consisting of a Phase 1b fixed-dose expansion followed by a Phase 2 efficacy evaluation. Receives: Drug: Ivonescimab Combined With Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicities in Phase 1b
Incidence of protocol-defined dose-limiting toxicities during the Phase 1b dose-limiting toxicity evaluation period.
Measured: From the first dose through Day 28.
Objective Response Rate
Proportion of participants with a best overall response of complete response or partial response according to modified Response for malignant pleural mesothelioma.
Measured: From the first dose through the last available tumor response assessment, up to 24 months.
Secondary outcomes (5)
Treatment-Emergent Adverse Events
Incidence and severity of treatment-emergent adverse events graded according to the Common Terminology Criteria for Adverse Events, version 5.0.
Measured: From the first dose through the last available safety assessment, up to 24 months.
Disease Control Rate
Proportion of participants with a best overall response of complete response, partial response, or stable disease according to modified Response Evaluation Criteria in Solid Tumors for malignant pleural mesothelioma.
Measured: From the first dose through the last available tumor response assessment, up to 24 months.
Progression-Free Survival
Time from the first dose of study treatment to the first documented disease progression or death from any cause, whichever occurs first.
Measured: From the first dose until disease progression or death from any cause, assessed up to 24 months.
Overall Survival
Time from the first dose of study treatment to death from any cause.
Measured: From the first dose until death from any cause, assessed up to 24 months.
Duration of Response
Time from the first documented complete response or partial response to the first documented disease progression according to modified Response Evaluation Criteria in Solid Tumors for malignant pleural mesothelioma or death from any cause, whichever occurs first.
Measured: From the first documented complete response or partial response until disease progression or death from any cause, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural Mesothelioma, AdvancedStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1b is a fixed-dose expansion at the candidate RP2D of ivonescimab 20 mg/kg, followed by Phase 2 evaluation at the confirmed RP2D.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Akeso Pharmaceuticals, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885319
- Sponsor's protocol ID
- 2024ZD0522805-IbII
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No