Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 Alone and in Combination in Patients With Selected Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEverest Medicines (Beijing) Co., Ltd.

About this trial

Brief Summary:

The purpose of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of EVM14 administered intramuscularly (IM) alone and in combination with pembrolizumab in patients with selected solid tumors.

Eligibility criteria

Qualifiers

Selected types of solid tumor that are pathologically confirmed unresectable advanced, recurrent, or metastatic.

Patients with at least 1 evaluable lesion assessed by Investigators within 28 days prior to the first dose of study treatment as defined per RECIST v1.1.

Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 at Screening.

Life expectancy ≥ 3 months.

Disqualifiers

Has disease that is suitable for local treatment administered with curative intent.

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.

Histologically/cytologically confirmed nasopharynx cancer. Has non-squamous histology NSCLC. If small cell elements are present, the patient is ineligible.

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Trial design

Treatments tested in this trial

  • EVM14
  • Pembrolizumab

Treatment groups

94 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.