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A Beta-only IL-2 ImmunoTherapY Study

ConditionsAdvanced Solid TumorUnresectable Solid TumorClear Cell Renal Cell CarcinomaTriple Negative Breast CancerNon-Small Cell Lung Cancer SquamousNon-Small Cell Lung Cancer Non-squamousColorectal Cancer (MSI-H)Gastric CancerCervical CancerBasal Cell CarcinomaBladder CancerMerkel Cell CarcinomaSquamous Cell Carcinoma of Head and NeckCutaneous Squamous Cell CarcinomaPleural MesotheliomaEsophageal CancerEndometrial CarcinomaSolid TumorSolid Tumor, AdultMSI-H Solid Malignant TumorCancer With A High Tumor Mutational BurdenEpithelial Ovarian CarcinomaPrimary Peritoneal CancerGastroesophageal Junction (GEJ) CancerAcral MelanomaMucosal MelanomaCutaneous MelanomaDMMR Solid Malignant TumorFallopian Tube CancerOvarian CancerMSI-H CancerDMMR CancerPancreas Adenocarcinoma (MSI-H)Skin CancerViral CancerCervical CancersEndometrial Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedicenna Therapeutics, Inc.

About this trial

This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged at least 18 years (inclusive at the time of informed consent).

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.

Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)

Disqualifiers

Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.

Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (<2 weeks of radiotherapy) to non-CNS disease.

Radiation therapy to the lung that is > 30Gy within 6 months prior to start of treatment.

Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MDNA11

    Drug

    MDNA11 will be administered, IV on a once every 2 weeks (Q2W) dosing schedule. Provisional dose cohorts for monotherapy dose escalation doses ranging from 0.003 to 0.6 (mg/kg): until determining the monotherapy Recommended Dose for Expansion (mRDE).

  • Pembrolizumab (KEYTRUDA®)

    Drug

    MDNA11 will be administered in combination with pembrolizumab, IV. MDNA11 dose range to be evaluated in combination with pembrolizumab until determining the combination Recommended Dose for Expansion (cRDE).

Treatment groups

115 Participants
are divided into 1 treatment group
Group A: MDNA11Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

MDNA11 Recommended Dose for Expansion for monotherapy (mRDE) and Recommended Dose for Expansion for combination (cRDE)

Evaluation of tolerability as measured by number of patients with dose limiting toxicities (DLTs)

Time frame
24 months
2

Incidence of Treatment Related Adverse Events (TRAEs)

Rate of TRAEs in patients with advanced solid tumors

Time frame
24 months
3

Incidence of Treatment Emergent Adverse Events (TEAEs)

Rate of TEAEs in patients with advanced solid tumors

Time frame
24 months

Secondary outcomes

1

Pharmacokinetic characteristics on MDNA11 - Cmax (ug/mL)

Maximum observed serum drug concentration

Time frame
Up to 24 months
2

Pharmacokinetic characteristics on MDNA11 - Tmax (h)

Time to maximum observed serum drug concentration

Time frame
Up to 24 months
3

Pharmacokinetic characteristics on MDNA11 - AUClast (h.ug/mL)

Area under the serum concentration vs time curve from time zero to the last measurable concentration

Time frame
Up to 24 months
4

Immunogenicity of MDNA11 (anti-drug antibodies)

Incidence and persistence of anti-drug antibodies to MDNA11

Time frame
Up to 24 months

Other outcomes

1

Analysis of immune characteristics of the tumor microenvironment

Measured by change in Tumor Infiltrating Lymphocyte (TIL) levels

Time frame
Up to 24 months

Sponsors and contacts

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

Medicenna Therapeutics, Inc.

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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