Health Trials

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.

ConditionsTriple 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 Recurrence
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOncoNano Medicine, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Ability to understand and willingness to sign written informed consent before performance of any study procedures

Age ≥ 18 years

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.

Participants must have a minimum of one injectable and measurable lesion.

Disqualifiers

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.

Major surgery within 4 weeks before the first dose of study drug.

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.

Prolongation of corrected QT (QTc) interval to >470 millisecond (ms) for males and females when electrolytes balance is normal.

Trial design

Treatments tested in this trial

  • ONM-501
  • Cemiplimab

Treatment groups

168 Participants
are divided into 3 treatment groups

Sponsors and collaborators

OncoNano Medicine, Inc.

Lead sponsor

Source ClinicalTrials.gov