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

September 8, 2026 updated by: Everest Medicines (Beijing) Co., Ltd.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Everest Medicines (Beijing) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 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)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 8, 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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