Skip to content
Study details
Enrolling now

A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab

OncoNano Medicine, Inc.
NCT IDNCT06022029ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1

Target enrollment

168

Study length

about 2.9 years

Ages

18+

Locations

9 sites in CA, FL, OH +3

About this study

Researchers are testing different doses of a drug (ONM-501) given directly into tumors, alone or with another medication (Cemiplimab), to see what the highest dose that can be safely used, the lowest effective dose, or a recommended dose for expansion is in people with advanced solid tumors and lymphomas. The trial will last about 1051 days.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Cemiplimab
  • 2.Take ONM-501
PhasePhase 1
DrugCemiplimab
Primary goalDose Escalation and Expansion Phases: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAEs)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low15%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

cemiplimab

Endpoints

Primary: Dose Escalation and Expansion Phases: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAEs), Dose Escalation and Expansion Phases: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity

Secondary: Dose Escalation and Expansion Phases: Cmax, Dose Escalation and Expansion Phases: Tmax, Expansion Phase Only: Duration of Response (DOR), Expansion Phase Only: Objective Response Rate (ORR), Expansion Phase Only: Overall Survival (OS), Expansion Phase Only: Progression-Free Survival (PFS)

Body systems

Oncology