Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma

NCT07885319 | Not Yet Recruiting Phase 1

• 1 other identifier: 2024ZD0522805-IbII
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

Brief 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. Phase 1b evaluates the candidate recommended Phase 2 dose (RP2D), followed by Phase 2 evaluation at the confirmed RP2D.

Conditions

Malignant Pleural Mesothelioma, Advanced

Keywords

Ivonescimab; Pemetrexed; Platinum-Based Chemotherapy; Phase 1b/2; First-Line Treatment

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicities in Phase 1b

  Incidence of protocol-defined dose-limiting toxicities during the Phase 1b dose-limiting toxicity evaluation period.

  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.

  From the first dose through the last available tumor response assessment, up to 24 months.

Secondary Outcomes (5)

• Treatment-Emergent Adverse Events

  From the first dose through the last available safety assessment, up to 24 months.

• Disease Control Rate

  From the first dose through the last available tumor response assessment, up to 24 months.

• Progression-Free Survival

  From the first dose until disease progression or death from any cause, assessed up to 24 months.

• Overall Survival

  From the first dose until death from any cause, assessed up to 24 months.

• Duration of Response

  From the first documented complete response or partial response until disease progression or death from any cause, assessed up to 24 months.

Study Arms (1)

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.

Drug: Ivonescimab Combined With Chemotherapy

Interventions

Ivonescimab Combined With Chemotherapy DRUG

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.

Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Akeso Pharmaceuticals, Inc.: collaborator

Study Sites (3)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Yi Xiang, MD, PhD

CONTACT

+86-21-64370045; xiangyiht@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)