NCT05086692 - A Beta-only IL-2 ImmunoTherapY Study | Biotech Hunter

Enrollment

115

Participants

Timeline

Start Date

August 27, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

December 30, 2026

Conditions

Advanced 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

Interventions

DRUG

MDNA11

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).

DRUG

Pembrolizumab (KEYTRUDA®)

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).

Trial Locations (27)

2031

RECRUITING

Scientia Clinical Research, Randwick

2109

RECRUITING

Macquarie University, Sydney

4120

RECRUITING

Gallipoli Medical Research Foundation, Greenslopes

4556

RECRUITING

University of the Sunshine Coast, Buderim

28034

RECRUITING

Hospital Universitario Ramón y Cajal, Madrid

28040

RECRUITING

START Madrid / Hospital Universitario Fundacion Jimenez Diaz, Madrid

28050

RECRUITING

Hospital Universitario Hm Sanchinarro, Madrid

28850

RECRUITING

Hospital Universitario de Torrejon, Torrejón

30322

RECRUITING

Emory - Winship Cancer Institute, Atlanta

33011

RECRUITING

Hospital Universitario Central de Asturias (HUCA), Oviedo

33486

RECRUITING

Boca Raton Regional Hospital, Boca Raton

48201

RECRUITING

Karmanos Cancer Institute, Detroit

77030

ACTIVE_NOT_RECRUITING

MD Anderson Cancer Center, Houston

90404

RECRUITING

Providence Saint John's Health Center, Santa Monica

92123

RECRUITING

Sharp Memorial Hospital, San Diego

94158

ACTIVE_NOT_RECRUITING

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

M4W 3E2

RECRUITING

Princess Margaret Cancer Center, Toronto

D07 R2WY

RECRUITING

Mater Misericordiae University Hospital, Dublin

1649-035

RECRUITING

START Lisbon - Centro de Ensaios Clínicos, ULS Sta Maria, Lisbon

4200-072

RECRUITING

Instituto Portugues De Oncologia Do Porto, Porto

Unknown

ACTIVE_NOT_RECRUITING

Samsung Medical Center, Seoul

ACTIVE_NOT_RECRUITING

Seoul National University Bundang Hospital, Seongnam-si

ACTIVE_NOT_RECRUITING

The Catholic University of Korea St. Vincent Hospital, Suwon

ACTIVE_NOT_RECRUITING

Seoul National University Hospital, Seoul

08916

RECRUITING

Institut Catala d'Oncologia (ICO)-Badalona, Badalona

08023

RECRUITING

START Barcelona / HM Nou Delfos, Barcelona

08041

RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona