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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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • ONM-501

    Drug

    Intratumoral injection

  • Cemiplimab

    Drug

    Intravenous administration of 350 mg

Treatment groups

168 Participants
are divided into 3 treatment groups
Group A: Part 1a: Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Part 1b: ONM-501 in Combination with cemiplimabExperimental treatment 2 interventions
Group C: Part 2: RDE ONM-501 in Combination with cemiplimab in indication-specific expansion cohortsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose Escalation and Expansion Phases: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity

AE incidence will be coded using Medical Dictionary for Regulatory Activities (MedDRA) terminology. AE severity will be graded according to NCI CTCAE version 5.0 or later. Grade 1 scales as Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 scales as Moderate (minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living \[ADL\]); Grade 3 scales as Severe (severe or medically significant but not immediately life threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 scales as Life-threatening consequences, urgent intervention indicated, and Grade 5 scales as Death related to Adverse Event (AE)

Time frame
Up to approximately 24 months
2

Dose Escalation and Expansion Phases: Number of Participants with Dose-Limiting Toxicities (DLTs)

DLT will be defined as the occurrence of any of the following events in the first 28 days of treatment in the dose escalation cohorts in Part 1 of the study or in the first 28 days of treatment for the first 6 patients at any dose in Part 1b (DLT observation periods). Any adverse event resulting in a dose hold or delay of ≥ 28 days will be considered a DLT. Toxicity will be evaluated according to NCI CTCAE version 5.0.

Time frame
Up to approximately 24 months
3

Dose Escalation and Expansion Phases: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAEs)

AE incidence will be coded using Medical Dictionary for Regulatory Activities (MedDRA) terminology. AE severity will be graded according to NCI CTCAE version 5.0 or later.

Time frame
Up to approximately 24 months

Secondary outcomes

1

Dose Escalation and Expansion Phases: Cmax

Cmax is defined as the Maximum Observed Plasma Concentration for ONM-501

Time frame
Dose Escalation and Expansion Phases: Cycle 1 Day 1 and Cycle 1 Day 8 (each cycle is 21 days): predose and at multiple timepoints (up to 24 hours).
2

Dose Escalation and Expansion Phases: t1/2z

t1/2z is defined as the Terminal Disposition Phase Half-life for ONM-501

Time frame
Dose Escalation and Expansion Phases: Cycle 1 Day 1 and Cycle 1 Day 8 (each cycle is 21 days): predose and at multiple timepoints (up to 24 hours).
3

Dose Escalation and Expansion Phases: Tmax

Tmax is defined as the Time to Reach the Maximum Plasma Concentration (Cmax) for ONM-501

Time frame
Dose Escalation and Expansion Phases: Cycle 1 Day 1 and Cycle 1 Day 8 (each cycle is 21 days): predose and at multiple timepoints (up to 24 hours).
4

Dose Escalation and Expansion Phases: AUCt

AUCt is defined as the Area Under the Concentration-time Curve from Time 0 to Time t for ONM-501

Time frame
Dose Escalation and Expansion Phases: Cycle 1 Day 1 and Cycle 1 Day 8 (each cycle is 21 days): predose and at multiple timepoints (up to 24 hours).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OncoNano Medicine, Inc.

Lead sponsor

Source ClinicalTrials.gov
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