Malignant Pleural Mesothelioma, AdvancedPhase 1NCT07885306
Safety and Preliminary Antitumor Activity of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
A Phase 1 study testing Ivonescimab Combined With Chemotherapy in people with Malignant Pleural Mesothelioma, Advanced, run by Ruijin Hospital at 2 sites in China.
Trial summary
This Phase 1a, open-label, dose-escalation study evaluates the safety, tolerability, and preliminary antitumor activity 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
- 9 participants
- Where
- 2 sitesChina
- Study dates
- 12 Mar 2025to 30 Nov 2028
- Phase
- Phase 1
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
2 sites in 1 country.
China2 sites
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: A Phase 1a, Open-Label, Dose-Escalation Study of Ivonescimab in Combination With Pemetrexed and Platinum-Based Chemotherapy as First-Line Treatment in Patients With Advanced Malignant Pleural Mesothelioma
This Phase 1a, open-label, dose-escalation study evaluates the safety, tolerability, and preliminary antitumor activity of ivonescimab in combination with pemetrexed and platinum-based chemotherapy as first-line treatment for advanced malignant pleural mesothelioma. Ivonescimab is evaluated at sequential dose levels of 3, 10, and 20 mg/kg using a 3+3 dose-escalation design.
Read the detailed description
Ivonescimab is administered at 3, 10, or 20 mg/kg every 3 weeks in combination with pemetrexed 500 mg/m² and cisplatin 75 mg/m² or carboplatin AUC 5 for 4 to 6 cycles. Dose escalation follows a conventional 3+3 design, with dose-limiting toxicities assessed during the first 28 days. Safety, tolerability, and preliminary antitumor activity are evaluated to support dose selection for subsequent dose expansion. 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, Dose Escalation, 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
Ivonescimab is administered intravenously at sequential dose levels of 3, 10, and 20 mg/kg 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. Maintenance treatment with ivonescimab at the assigned dose with or without pemetrexed may be continued Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy | Experimental | A single experimental arm consisting of sequential ivonescimab dose-escalation cohorts using a conventional 3+3 design. 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
Incidence of protocol-defined dose-limiting toxicities.
Measured: From the first dose through Day 28
Secondary outcomes (5)
Treatment-Emergent Adverse Events
Incidence and severity of treatment-emergent adverse events according to CTCAE v5.0.
Measured: From the first dose through the last available safety assessment, up to 24 months.
Objective Response Rate
Proportion of participants with a best overall response of complete response or partial response according to modified RECIST for malignant pleural mesothelioma.
Measured: From the first dose through the last available tumor response 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 RECIST 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 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 to death from any cause.
Measured: From the first dose until 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 start12 Mar 2025
- Primary completion13 Aug 2026
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Participants were enrolled sequentially into ivonescimab dose cohorts of 3, 10, and 20 mg/kg using a conventional 3+3 dose-escalation design.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
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
- NCT07885306
- Sponsor's protocol ID
- 2024ZD0522805 Ia
- 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