Phase
Condition
Melanoma
Cervical Cancer
Ovarian Cysts
Treatment
TransCon TLR7/8 Agonist
Pembrolizumab
Trastuzumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 mustagree to use highly effective methods of contraception
Participants must have histologically confirmed locally advanced, recurrent, ormetastatic 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, oranti-cytotoxic T-lymphocyte-associated protein (CTLA-4) antibody must have a washoutof at least 4 weeks from the last dose and evidence of disease progression perinvestigator assessment before Cycle 1 Day 1 (C1D1) with the exception of theneoadjuvant cohorts
Participants who have previously received an immunotherapy prior to C1D1 must haveany immune-related toxicities resolved to ≤Grade 1 or baseline (prior to theimmunotherapy) to be eligible, with the exception of participants on well controlledphysiologic endocrine replacement
Part 3: Neoadjuvant cohorts: participants must have completely resectable disease
Exclusion
Key Exclusion Criteria:
Symptomatic central nervous system metastases and/or carcinomatous meningitis
Active autoimmune diseases, regardless of need for immunosuppressive treatment, withthe 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]) usingFridericia's QT correction formula
Positive for human immunodeficiency virus (HIV) or has known active hepatitis B or Cinfection
Known hypersensitivity to any study treatment(s) used in the specific studypart/cohort
Participants who have been previously treated with IL-2 or IL-2 variants (allparticipants)
Systemic immunosuppressive treatment with the exception for patients oncorticosteroid taper (for example, for chronic obstructive pulmonary diseaseexacerbation).
Vaccination with live, attenuated vaccines within 4 weeks of C1D1
Treatment with any other anti-cancer systemic treatment (approved orinvestigational) 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
Study Design
Study Description
Connect with a study center
Ascendis Pharma Investigational Site
Adelaide, 5000
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Adelaide 2078025, 5000
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Brisbane, 04120
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Brisbane 2174003, 04120
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Frankston, 3199
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Frankston 2166144, 3199
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Southport, 4215
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Southport 2148928, 4215
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Toorak Gardens, 05065
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Toorak Gardens 8348006, 05065
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Waratah, 2298
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Waratah 10103871, 2298
AustraliaSite Not Available
Ascendis Pharma Investigational Site
Wilrijk, 2610
BelgiumSite Not Available
Ascendis Pharma Investigational Site
Wilrijk 2783615, 2610
BelgiumSite Not Available
Ascendis Pharma Investigational Site
Montreal 6077243, H4A 3J1
CanadaSite Not Available
Ascendis Pharma Investigational Site
Montréal, H2X-0A9
CanadaSite Not Available
Ascendis Pharma Investigational Site
Toronto, M5G 2C4
CanadaSite Not Available
Ascendis Pharma Investigational Site
Toronto 6167865, M5G 2C4
CanadaSite Not Available
Ascendis Pharma Investigational Site
Cuneo, 12100
ItalySite Not Available
Ascendis Pharma Investigational Site
Cuneo 3177700, 12100
ItalySite Not Available
Ascendis Pharma Investigational Site
Firenze, 50134
ItalySite Not Available
Ascendis Pharma Investigational Site
Florence 3176959, 50134
ItalySite Not Available
Ascendis Pharma Investigational Site
Grosseto, 58100
ItalySite Not Available
Ascendis Pharma Investigational Site
Grosseto 3175786, 58100
ItalySite Not Available
Ascendis Pharma Investigational Site
Lido Di Camaiore, 55041
ItalySite Not Available
Ascendis Pharma Investigational Site
Lido di Camaiore 3174743, 55041
ItalySite Not Available
Ascendis Pharma Investigational Site
Livorno, 57124
ItalySite Not Available
Ascendis Pharma Investigational Site
Livorno 3174659, 57124
ItalySite Not Available
Ascendis Pharma Investigational Site
Meldola, 47014
ItalySite Not Available
Ascendis Pharma Investigational Site
Meldola 3173635, 47014
ItalySite Not Available
Ascendis Pharma Investigational Site
Milan, 20133
ItalySite Not Available
Ascendis Pharma Investigational Site
Milan 3173435, 20141
ItalySite Not Available
Ascendis Pharma Investigational Site
Modena, 41124
ItalySite Not Available
Ascendis Pharma Investigational Site
Modena 3173331, 41124
ItalySite Not Available
Ascendis Pharma Investigational Site
Roma, 00167
ItalySite Not Available
Ascendis Pharma Investigational Site
Roma 8957247, 00167
ItalySite Not Available
Ascendis Pharma Investigational Site
Torino, 10126
ItalySite Not Available
Ascendis Pharma Investigational Site
Torino 8980539, 10126
ItalySite Not Available
Ascendis Pharma Investigational Site
Turin, 10060
ItalySite Not Available
Ascendis Pharma Investigational Site
Turin 3165524, 10060
ItalySite Not Available
Ascendis Pharma Investigational Site
Verona, 37134
ItalySite Not Available
Ascendis Pharma Investigational Site
Verona 3164527, 37134
ItalySite Not Available
Ascendis Pharma Investigational Site
Seongnam-si, 13620
Korea, Republic ofSite Not Available
Ascendis Pharma Investigational Site
Seoul, 03080
Korea, Republic ofSite Not Available
Ascendis Pharma Investigational Site
Krakow 3094802, 31-501
PolandSite Not Available
Ascendis Pharma Investigational Site
Kraków, 31-501
PolandSite Not Available
Ascendis Pharma Investigational Site
Poznan 3088171, 60693
PolandSite Not Available
Ascendis Pharma Investigational Site
Poznań, 60693
PolandSite Not Available
Ascendis Pharma Investigational Site
Warsaw 756135, 02-781
PolandSite Not Available
Ascendis Pharma Investigational Site
Warszawa, 02-781
PolandSite Not Available
Ascendis Pharma Investigational Site
Singapore, 119228
SingaporeSite Not Available
Ascendis Pharma Investigational Site
Singapore 1880252, 217562
SingaporeSite Not Available
Ascendis Pharma Investigational Site
Seongnam-si 1897000, 13620
South KoreaSite Not Available
Ascendis Pharma Investigational Site
Seoul 1835848, 03080
South KoreaSite Not Available
Ascendis Pharma Investigational Site
Barcelona, 08035
SpainSite Not Available
Ascendis Pharma Investigational Site
Barcelona 3128760, 08035
SpainSite Not Available
Ascendis Pharma Investigational Site
L'Hospitalet De Llobregat, 08908
SpainSite Not Available
Ascendis Pharma Investigational Site
L'Hospitalet de Llobregat 3120619, 08908
SpainSite Not Available
Ascendis Pharma Investigational Site
Madrid, 28006
SpainSite Not Available
Ascendis Pharma Investigational Site
Madrid 3117735, 28041
SpainSite Not Available
Ascendis Pharma Investigational Site
Murcia, 30120
SpainSite Not Available
Ascendis Pharma Investigational Site
Murcia 2513416, 30120
SpainSite Not Available
Ascendis Pharma Investigational Site
Málaga, 29010
SpainSite Not Available
Ascendis Pharma Investigational Site
Málaga 2514256, 29010
SpainSite Not Available
Ascendis Pharma Investigational Site
Oviedo, 33011
SpainSite Not Available
Ascendis Pharma Investigational Site
Oviedo 3114711, 33011
SpainSite Not Available
Ascendis Pharma Investigational Site
Pamplona, 31008
SpainSite Not Available
Ascendis Pharma Investigational Site
Pamplona 3114472, 31008
SpainSite Not Available
Ascendis Pharma Investigational Site
Sevilla, 41014
SpainSite Not Available
Ascendis Pharma Investigational Site
Seville 2510911, 41009
SpainSite Not Available
Ascendis Pharma Investigational Site
Valencia, 46014
SpainSite Not Available
Ascendis Pharma Investigational Site
Valencia 2509954, 46009
SpainSite Not Available
Ascendis Pharma Investigational Site
Taipei, 10002
TaiwanSite Not Available
Ascendis Pharma Investigational Site
Taipei 1668341, 10002
TaiwanSite Not Available
Ascendis Pharma Investigational Site
Los Angeles, California 90048
United StatesSite Not Available
Ascendis Pharma Investigational Site
Los Angeles 5368361, California 5332921 90048
United StatesSite Not Available
Ascendis Pharma Investigational Site
Springfield, Illinois 62702
United StatesSite Not Available
Ascendis Pharma Investigational Site
Springfield 4250542, Illinois 4896861 62702
United StatesSite Not Available
Ascendis Pharma Investigational Site
Louisville, Kentucky 40202
United StatesSite Not Available
Ascendis Pharma Investigational Site
Louisville 4299276, Kentucky 6254925 40202
United StatesSite Not Available
Ascendis Pharma Investigational Site
Boston, Massachusetts 02114
United StatesSite Not Available
Ascendis Pharma Investigational Site
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Ascendis Pharma Investigational Site
Morristown, New Jersey 07960
United StatesSite Not Available
Ascendis Pharma Investigational Site
Morristown 5101427, New Jersey 5101760 07960
United StatesSite Not Available
Ascendis Pharma Investigational Site
New York, New York 10032
United StatesSite Not Available
Ascendis Pharma Investigational Site
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Ascendis Pharma Investigational Site
Huntersville, North Carolina 28078
United StatesSite Not Available
Ascendis Pharma Investigational Site
Huntersville 4472370, North Carolina 4482348 28078
United StatesSite Not Available
Ascendis Pharma Investigational Site
Canton, Ohio 44718
United StatesSite Not Available
Ascendis Pharma Investigational Site
Cincinnati, Ohio 45219
United StatesSite Not Available
Ascendis Pharma Investigational Site
Canton 5149222, Ohio 5165418 44718
United StatesSite Not Available
Ascendis Pharma Investigational Site
Cincinnati 4508722, Ohio 5165418 45219
United StatesSite Not Available
Ascendis Pharma Investigational Site
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Ascendis Pharma Investigational Site
Oklahoma City 4544349, Oklahoma 4544379 73104
United StatesSite Not Available
Ascendis Pharma Investigational Site
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
Ascendis Pharma Investigational Site
Pittsburgh 5206379, Pennsylvania 6254927 15232
United StatesSite Not Available
Ascendis Pharma Investigational Site
Nashville, Tennessee 37203
United StatesSite Not Available
Ascendis Pharma Investigational Site
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
Ascendis Pharma Investigational Site
Richmond, Virginia 23298
United StatesSite Not Available
Ascendis Pharma Investigational Site
Richmond 4781708, Virginia 6254928 23298
United StatesSite Not Available

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