Volver a Ensayos Clínicos
NCT05081609
Un estudio para investigar la seguridad y la tolerabilidad de TransCon IL-2 β/γ, solo o en combinación con pembrolizumab y/o un agonista de TransCon TLR7/8, u otras terapias contra el cáncer, en participantes adultos con tumores sólidos avanzados localmente o metastásicos.
Activo, No Reclutando
Fase 1
Descripción
TransCon IL-2 β/γ es un fármaco en investigación que se está desarrollando para el tratamiento de tumores sólidos localmente avanzados o metastásicos. Este es un estudio de fase 1/2, de escalada de dosis y expansión de dosis, abierto y en primera administración en humanos, para evaluar TransCon IL-2 β/γ como monoterapia o en combinación en participantes adultos con tumores sólidos avanzados o metastásicos. Dada la farmacocinética única que permite la tecnología TransCon, TransCon IL-2 β/γ presenta la oportunidad de mejorar el índice terapéutico de la terapia actual con IL-2.
Criterios de Elegibilidad
Key Inclusion Criteria:
- At least 18 years of age, or country defined local legal age
- Demonstrated adequate organ function at screening
- Life expectancy \>12 weeks as determined by the Investigator
- Female and male participants of childbearing potential who are sexually active must agree to use highly effective methods of contraception
- Participants must have histologically confirmed locally advanced, recurrent, or metastatic solid tumor malignancies that cannot be treated with curative intent (surgery or radiotherapy), with the exception of the neoadjuvant cohorts
- Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Part 3 and Part 4: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Participants who have undergone treatment with anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated protein (CTLA-4) antibody must have a washout of at least 4 weeks from the last dose and evidence of disease progression per investigator assessment before Cycle 1 Day 1 (C1D1) with the exception of the neoadjuvant cohorts
- Participants who have previously received an immunotherapy prior to C1D1 must have any immune-related toxicities resolved to ≤Grade 1 or baseline (prior to the immunotherapy) to be eligible, with the exception of participants on well controlled physiologic endocrine replacement
- Part 3: Neoadjuvant cohorts: participants must have completely resectable disease
Key Exclusion Criteria:
- Symptomatic central nervous system metastases and/or carcinomatous meningitis
- Active autoimmune diseases, regardless of need for immunosuppressive treatment, with the exception of participants well controlled on physiologic endocrine replacement
- Any uncontrolled bacterial, fungal, viral, or other infection
- Significant cardiac disease
- A marked clinically significant baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>480 ms) \[CTCAE Grade 1\]) using Fridericia's QT correction formula
- Positive for human immunodeficiency virus (HIV) or has known active hepatitis B or C infection
- Known hypersensitivity to any study treatment(s) used in the specific study part/cohort
- Participants who have been previously treated with IL-2 or IL-2 variants (all participants)
- Systemic immunosuppressive treatment with the exception for patients on corticosteroid taper (for example, for chronic obstructive pulmonary disease exacerbation).
- Vaccination with live, attenuated vaccines within 4 weeks of C1D1
- Treatment with any other anti-cancer systemic treatment (approved or investigational) or radiation therapy within 4 weeks of C1D1
- Part 3: Other active malignancies within the last 2 years
- Women who are breastfeeding or have a positive serum pregnancy test during screening
Información del Ensayo
NCT05081609
Activo, No Reclutando
Fase 1
320 participantes
Ene 2022
Ubicaciones68
Australia (7)
Ascendis Pharma Investigational Site
Adelaide, 5000
Ascendis Pharma Investigational Site
Adelaide, 5042
Ascendis Pharma Investigational Site
Brisbane, 04120
Ascendis Pharma Investigational Site
Frankston, 3199
Ascendis Pharma Investigational Site
Southport, 4215
Ascendis Pharma Investigational Site
Toorak Gardens, 05065
Ascendis Pharma Investigational Site
Waratah, 2298
Belgium (1)
Ascendis Pharma Investigational Site
Wilrijk, 2610
Canada (3)
Ascendis Pharma Investigational Site
Montreal, H4A 3J1
Ascendis Pharma Investigational Site
Toronto, M4N 3M5
Ascendis Pharma Investigational Site
Toronto, M5G 2C4
Italy (13)
Ascendis Pharma Investigational Site
Cuneo, 12100
Ascendis Pharma Investigational Site
Florence, 50134
Ascendis Pharma Investigational Site
Grosseto, 58100
Ascendis Pharma Investigational Site
Lido di Camaiore, 55041
Ascendis Pharma Investigational Site
Livorno, 57124
Ascendis Pharma Investigational Site
Meldola, 47014
Ascendis Pharma Investigational Site
Milan, 20133
Ascendis Pharma Investigational Site
Milan, 20141
Ascendis Pharma Investigational Site
Modena, 41124
Ascendis Pharma Investigational Site
Roma, 00167
Ascendis Pharma Investigational Site
Torino, 10126
Ascendis Pharma Investigational Site
Turin, 10060
Ascendis Pharma Investigational Site
Verona, 37134
Poland (3)
Ascendis Pharma Investigational Site
Krakow, 31-501
Ascendis Pharma Investigational Site
Poznan, 60693
Ascendis Pharma Investigational Site
Warsaw, 02-781
Singapore (2)
Ascendis Pharma Investigational Site
Singapore, 119228
Ascendis Pharma Investigational Site
Singapore, 217562
South Korea (6)
Ascendis Pharma Investigational Site
Seongnam-si, 13620
Ascendis Pharma Investigational Site
Seoul, 03080
Ascendis Pharma Investigational Site
Seoul, 03722
Ascendis Pharma Investigational Site
Seoul, 06231
Ascendis Pharma Investigational Site
Seoul, 06351
Ascendis Pharma Investigational Site
Seoul, Songpa-gu, 05505
Spain (17)
Ascendis Pharma Investigational Site
Barcelona, 08023
Ascendis Pharma Investigational Site
Barcelona, 08028
Ascendis Pharma Investigational Site
Barcelona, 08035
Ascendis Pharma Investigational Site
L'Hospitalet de Llobregat, 08908
Ascendis Pharma Investigational Site
Madrid, 28006
Ascendis Pharma Investigational Site
Madrid, 28027
Ascendis Pharma Investigational Site
Madrid, 28040
Ascendis Pharma Investigational Site
Madrid, 28041
Ascendis Pharma Investigational Site
Madrid, 28050
Ascendis Pharma Investigational Site
Málaga, 29010
Ascendis Pharma Investigational Site
Murcia, 30120
Ascendis Pharma Investigational Site
Oviedo, 33011
Ascendis Pharma Investigational Site
Pamplona, 31008
Ascendis Pharma Investigational Site
Seville, 41009
Ascendis Pharma Investigational Site
Seville, 41014
Ascendis Pharma Investigational Site
Valencia, 46009
Ascendis Pharma Investigational Site
Valencia, 46014
Taiwan (2)
Ascendis Pharma Investigational Site
Taipei, 10002
Ascendis Pharma Investigational Site
Taipei, 11259
United States (14)
Ascendis Pharma Investigational Site
Los Angeles, California, 90048
Ascendis Pharma Investigational Site
Los Angeles, California, 90067
Ascendis Pharma Investigational Site
Springfield, Illinois, 62702
Ascendis Pharma Investigational Site
Louisville, Kentucky, 40202
Ascendis Pharma Investigational Site
Boston, Massachusetts, 02114
Ascendis Pharma Investigational Site
Morristown, New Jersey, 07960
Ascendis Pharma Investigational Site
New York, New York, 10032
Ascendis Pharma Investigational Site
Huntersville, North Carolina, 28078
Ascendis Pharma Investigational Site
Canton, Ohio, 44718
Ascendis Pharma Investigational Site
Cincinnati, Ohio, 45219
Ascendis Pharma Investigational Site
Oklahoma City, Oklahoma, 73104
Ascendis Pharma Investigational Site
Pittsburgh, Pennsylvania, 15232
Ascendis Pharma Investigational Site
Nashville, Tennessee, 37203
Ascendis Pharma Investigational Site
Richmond, Virginia, 23298