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

NCT07614646 | Not Yet Recruiting Phase 1

• 1 other identifier: EVM14CX01
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Squamous Non-Small Cell Lung Cancer sqNSCLC

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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.

Study Arms (1)

EVM14 at Dose Escalation Level plus +Ivonescimab Administered 200mg Q3W

EXPERIMENTAL

Biological: EVM14; Biological: Ivonescimab

Interventions

EVM14 BIOLOGICAL

Cancer Vaccine, Intramuscular (IM) injection at escalating dose levels, administered once every 3 weeks (Q3W)

EVM14 at Dose Escalation Level plus +Ivonescimab Administered 200mg Q3W

Ivonescimab BIOLOGICAL

Anti PD 1/VEGF bispecific antibody, administered intravenously at a dose of 200 mg once every 3 weeks

EVM14 at Dose Escalation Level plus +Ivonescimab Administered 200mg Q3W

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Known positive PD-L1 expression in tumor tissue prior to enrollment, with Tumor Proportion Score (TPS) ≥ 1% assessed via the 22C3 assay.
• 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.
• Patients with at least 1 measurable lesion as defined per RECIST v1.1.
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
• Life expectancy ≥ 6 months.
• Patients must have adequate organ function.

You may not qualify if:

• Has disease that is suitable for local treatment administered with curative intent.
• Cannot provide sufficient tumor slides for biomarker testing.
• 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.
• Active central nervous system (CNS) metastases. Patients with clinically stable brain metastases are eligible for enrollment.
• 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.
• Has received prior systemic anti-angiogenic therapy or any tumor-directed immunotherapy
• The left ventricular ejection fraction (LVEF) \< 50% during the screening period.
• Patients known to be human immunodeficiency virus (HIV)-positive.

Sponsors & Collaborators

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

Central Study Contacts

Everest Clinical Trial Information Center

CONTACT

+86 21 8012 5712; ctinfo.center@everestmedicines.com

Study Design

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

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05