A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.

Part of paid clinical trials in Los Angeles, California.

Sponsor
OncoNano Medicine, Inc.
Study ID
NCT06022029
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ONM-501 — DRUG
    Intratumoral injection
  • Cemiplimab — DRUG
    Intravenous administration of 350 mg

Study Details

A phase 1, multicenter, open label, non-randomized dose escalation and dose expansion study to examine the maximum tolerated dose, (MTD), minimum effective dose (MED) and/or recommended dose for expansion (RDE) of intratumoral ONM-501 as monotherapy and in combination with a PD-1 checkpoint inhibitor in patients with advanced solid tumors and lymphomas.

Key Dates

Start date
Oct 13, 2023
Status verified
Dec 2025
Primary completion
Apr 30, 2026
Completion
Aug 29, 2026

Study Design

Enrollment
168 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1a: Monotherapy Dose Escalation
    ONM-501 will be administered as intratumoral injections once per week for three weeks, followed by three weeks without ONM-501 administration. Each dosing cycle will be 21 days.
  • Experimental: Part 1b: ONM-501 in Combination with cemiplimab
    ONM-501 will be administered as intratumoral injections once per week for three weeks followed by three weeks without ONM-501 administration. Each dosing cycle will be 21 days. The combination agent will be administered according to standard protocol, once every three weeks.
  • Experimental: Part 2: RDE ONM-501 in Combination with cemiplimab in indication-specific expansion cohorts
    Once the recommended doses for expansion (RDEs) are determined for ONM-501 + ICI combination or ONM-501 monotherapy, the expansion phase of the study will be initiated. The expansion phase will enroll patients in one to three indication-specific expansion cohorts.

Primary Outcome Measure

Dose Escalation and Expansion Phases: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity [ Time Frame: Up to approximately 24 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
California Research InstituteLos AngelesCalifornia90027-
BRCR GlobalTamaracFlorida33321-
Gabrail Cancer Center ResearchCantonOhio44718-
Ohio State UniversityColumbusOhio43210-
Allegheny Health NetworkPittsburghPennsylvania15224-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
University of Texas Southwestern Medical CenterDallasTexas75390-
MD Anderson Cancer CenterHoustonTexas77030-
Virginia Cancer Specialists, PCFairfaxVirginia22031-

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