Clinical trial · Interventional
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
NCT07614646CI-TRIAL-00112923not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Non-Small Cell Lung Cancer sqNSCLC | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EVM14 | Biological | — | UNRESOLVED |
| Ivonescimab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EVM14 at Dose Escalation Level plus +Ivonescimab Administered 200mg Q3W
- interventionNames
- Biological: EVM14
- Biological: Ivonescimab
Primary outcomes (2)
- measure
- Incidence of dose-limiting toxicity (DLT)
- timeFrame
- 21days since the 1st EVM14 dose
- measure
- Incidence and severity of TEAE, TRAE, SAEs, and adverse events (AEs) of Grade ≥ 3
- timeFrame
- From first dose until 30±7 days post-last dose
Secondary outcomes (4)
- measure
- Objective Response Rate(ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.