Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 in Combination With Ivonescimab in Sq-NSCLC Patients

A Phase Ia Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 Combined With Ivonescimab in Patients With Squamous Non-Small Cell Lung Cancer

The purpose of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of EVM14 administered intramuscularly (IM) combination with Ivonescimab in patients with sq-NSCLC.

Study Overview

• Status: Not yet recruiting
• Conditions: Squamous Non-Small Cell Lung Cancer sqNSCLC
• Intervention / Treatment: Biological: EVM14; Biological: Ivonescimab

• Study Type: Interventional
• Enrollment (Estimated): 13
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Everest Clinical Trial Information Center; Phone Number: +86 21 8012 5712; Email: ctinfo.center@everestmedicines.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous non-small-cell lung cancer (sq-NSCLC), which is unresectable or not curable by definitive concurrent/sequential chemoradiotherapy.
2. Known positive PD-L1 expression in tumor tissue prior to enrollment, with Tumor Proportion Score (TPS) ≥ 1% assessed via the 22C3 assay.
3. No prior systemic anti-tumor therapy. Neoadjuvant/adjuvant systemic chemoradiotherapy for curative intent in non-metastatic disease, or definitive concurrent/sequential chemoradiotherapy for locally advanced disease, are permitted, provided disease progression occurs ≥ 6 months after the last treatment.
4. Patients with at least 1 measurable lesion as defined per RECIST v1.1.
5. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
6. Life expectancy ≥ 6 months.
7. Patients must have adequate organ function.

Exclusion Criteria:

1. Has disease that is suitable for local treatment administered with curative intent.
2. Cannot provide sufficient tumor slides for biomarker testing.
3. Has a diagnosed and/or treated additional malignancy within 5 years prior to the first dose of study treatment except for: curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, and curatively resected in situ breast, cervical cancer, and prostate cancer.
4. Active central nervous system (CNS) metastases. Patients with clinically stable brain metastases are eligible for enrollment.
5. Has active autoimmune disease that has required systemic treatment in past 2 years or history of autoimmune disease that has possibility of relapse or at risk of having these conditions.
6. Has received prior systemic anti-angiogenic therapy or any tumor-directed immunotherapy
7. The left ventricular ejection fraction (LVEF) < 50% during the screening period.
8. Patients known to be human immunodeficiency virus (HIV)-positive.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EVM14 at Dose Escalation Level plus +Ivonescimab Administered 200mg Q3W	Biological: EVM14; Cancer Vaccine, Intramuscular (IM) injection at escalating dose levels, administered once every 3 weeks (Q3W); Biological: Ivonescimab; Anti PD 1/VEGF bispecific antibody, administered intravenously at a dose of 200 mg once every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of dose-limiting toxicity (DLT)	21days since the 1st EVM14 dose
Incidence and severity of TEAE, TRAE, SAEs, and adverse events (AEs) of Grade ≥ 3	From first dose until 30±7 days post-last dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate(ORR)	up to 24 months.
Duration of Response(DOR)	up to 24 months.
Disease Control Rate(DCR)	up to 24 months.
Progression-Free Survival(PFS)	up to 24 months.

Collaborators and Investigators

• Sponsor: Everest Medicines (Beijing) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: EVM14CX01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No