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

Conditions

• Selected Types of Solid Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• EVM14 — BIOLOGICAL
  Cancer Vaccine
• Pembrolizumab — COMBINATION_PRODUCT
  Anti-PD1 antibody

Study Details

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.

Key Dates

Start date

Nov 17, 2025

Status verified

May 2026

Primary completion

Nov 30, 2029

Completion

Nov 30, 2031

Study Design

Enrollment

94 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase I Dose Escalation in Monotherapy Cohort
• Experimental: Phase I Dose Escalation in Combination Therapy Cohort
• Experimental: Phase IIa Dose Level A for tumor type 1
• Experimental: Phase IIa Dose Level B for tumor type 1
• Active Comparator: Phase IIa Control arm for tumor type 1
• Experimental: Phase IIa Combo therapy for tumor type 2
• Active Comparator: Phase IIa Control for tumor type 2
  For patients with tumor type 2, pembrolizumab 200 mg alone will be administered intravenously (IV infusion) every 3 weeks (Q3W) if disease progression doesn't occur.

Primary Outcome Measure

Phase I and Phase IIa: Incidence and severity of adverse events [ Time Frame: From the the start of the first dose of study treatment to 90 days after the last study treatment or new anti-cancer treatments started, whichever occurs earlier. ]

Central Contacts

• Everest Clinical Trial Information Center
  +86 21 8012 5712
  [email protected]

Locations (3)

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