RECRUITING

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.

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Conditions

Triple Negative Breast CancerDiffuse Large B Cell LymphomaFollicular LymphomaLymphoma, Non-HodgkinMantle Cell LymphomaBladder CancerUveal Melanoma, RecurrentCervix CancerCarcinoma in SituHead and Neck Squamous Cell CarcinomaSkin CancerMetastatic CancerTumor, SolidTumor RecurrenceSolid tumorsLymphomaONM-501STINGIntra-tumoralHNSCCBreast CancerMelanomacemiplimabLibtayoDLBCLcervical cancermetastasesimmunotherapyICITNBCTriple NegativemTNBCanti-PD-1 antibodyBRCA1BRCA2anti-PD-L1uvealNHLMantle Zone lymphomaFLstimulator of interferon genes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination with Cemiplimab in Patients with Advanced Solid Tumors and Lymphomas

Quick Facts

Study Start:2023-10-13
Study Completion:2026-08-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06022029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ability to understand and willingness to sign written informed consent before performance of any study procedures
  2. 2. Age ≥ 18 years
  3. 3. Participants with solid tumors or lymphomas, confirmed by available histopathology records or current biopsy, that are advanced, nonresectable, or recurrent and progressing since last antitumor therapy, and for which no alternative standard therapy exists.
  4. 4. Participants must have a minimum of one injectable and measurable lesion.
  5. 5. Participants with prior Hepatitis B or C are eligible if they have adequate liver function
  6. 6. Participants with human immunodeficiency virus (HIV) are eligible if on established HAART for a minimum of 4 weeks prior to enrollment, have an HIV viral load \<400 copies/mL, and have CD4+ T-cell (CD4+) counts ≥ 350 cells/uL
  7. 7. Adequate bone marrow function:
  8. 8. Adequate liver function
  1. 1. Other malignancy active within the previous 2 years except for basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has completed curative therapy.
  2. 2. Major surgery within 4 weeks before the first dose of study drug.
  3. 3. Brain metastases that are untreated or in the posterior fossa or involve the meninges. Participants with stable or previously treated progressing brain metastases (except in the posterior fossa or involving the meninges) may be permitted in a case-by-case basis at the Sponsor's discretion.
  4. 4. Prolongation of corrected QT (QTc) interval to \>470 millisecond (ms) for males and females when electrolytes balance is normal.
  5. 5. Females who are breastfeeding or pregnant at screening or baseline
  6. 6. Females of childbearing potential that refuse to use a highly effective method of contraception.
  7. 7. Has uncontrolled or poorly controlled hypertension as defined by a sustained BP \> 9. 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.
  8. 8. Has had any major cardiovascular event within 6 months prior to study drug 10. Has known hypersensitivity to any component in the formulation of ONM-501
  9. 9. Has an active infection requiring systemic treatment
  10. 10. Is participating in another therapeutic clinical trial
  11. 1. Has known hypersensitivity to any component in the formulation of cemiplimab
  12. 2. Has any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\>10 mg daily prednisone equivalent)
  13. 3. Has a condition requiring systemic treatment with corticosteroids

Contacts and Locations

Study Contact

Trials@OncoNanoMed.com
CONTACT
(682) 285-1411
trials@onconanomed.com

Study Locations (Sites)

California Research Institute
Los Angeles, California, 90027
United States
BRCR Global
Tamarac, Florida, 33321
United States
Gabrail Cancer Center Research
Canton, Ohio, 44718
United States
Ohio State University
Columbus, Ohio, 43210
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Allegheny Health Network
Pittsburg, Pennsylvania, 15224
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: OncoNano Medicine, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-13
Study Completion Date2026-08-29

Study Record Updates

Study Start Date2023-10-13
Study Completion Date2026-08-29

Terms related to this study

Keywords Provided by Researchers

  • Solid tumors
  • Lymphoma
  • ONM-501
  • STING
  • Intra-tumoral
  • HNSCC
  • Breast Cancer
  • Melanoma
  • Skin Cancer
  • cemiplimab
  • Libtayo
  • DLBCL
  • bladder cancer
  • cervical cancer
  • metastases
  • immunotherapy
  • ICI
  • TNBC
  • Triple Negative
  • mTNBC
  • anti-PD-1 antibody
  • BRCA1
  • BRCA2
  • anti-PD-L1
  • uveal
  • NHL
  • Mantle Zone lymphoma
  • FL
  • stimulator of interferon genes

Additional Relevant MeSH Terms

  • Triple Negative Breast Cancer
  • Diffuse Large B Cell Lymphoma
  • Follicular Lymphoma
  • Lymphoma, Non-Hodgkin
  • Mantle Cell Lymphoma
  • Bladder Cancer
  • Uveal Melanoma, Recurrent
  • Cervix Cancer
  • Carcinoma in Situ
  • Head and Neck Squamous Cell Carcinoma
  • Skin Cancer
  • Metastatic Cancer
  • Tumor, Solid
  • Tumor Recurrence