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OncoMatch/Clinical Trials/NCT06022029

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.

Is NCT06022029 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including ONM-501 and Cemiplimab for triple negative breast cancer.

Phase 1RecruitingOncoNano Medicine, Inc.NCT06022029Data as of May 2026

Treatment: ONM-501 · CemiplimabA 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.

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Extracted eligibility criteria

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Urothelial Carcinoma

Melanoma

Cervical Cancer

Head and Neck Squamous Cell Carcinoma

Tumor Agnostic

Prior therapy

Min 1 prior line

Must have received: antitumor therapy

progressing since last antitumor therapy, and for which no alternative standard therapy exists

Cannot have received: investigational therapy

Has received prior investigational therapy within 5 half-lives of the agent or 4 weeks before the first administration of study drug, whichever is shorter

Lab requirements

Blood counts

adequate bone marrow function

Liver function

adequate liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • California Research Institute · Los Angeles, California
  • BRCR Global · Tamarac, Florida
  • Gabrail Cancer Center Research · Canton, Ohio
  • Ohio State University · Columbus, Ohio
  • Allegheny Health Network · Pittsburgh, Pennsylvania

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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