A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

Last updated: February 23, 2026
Sponsor: Ascendis Pharma Oncology Division A/S
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Melanoma

Cervical Cancer

Ovarian Cysts

Treatment

TransCon TLR7/8 Agonist

Pembrolizumab

Trastuzumab

Clinical Study ID

NCT05081609
ASND0029
  • Ages > 18
  • All Genders

Study Summary

TransCon IL-2 β/γ is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This is a first-in-human, open-label, Phase 1/2, dose escalation and dose expansion study of TransCon IL-2 β/γ as monotherapy or in combination therapy in adult participants with advanced or metastatic solid tumors. Given the unique PK profile enabled by the TransCon technology, TransCon IL-2 β/γ presents the opportunity to enhance the therapeutic index of current IL-2 therapy.

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

Total Participants: 320
Treatment Group(s): 7
Primary Treatment: TransCon TLR7/8 Agonist
Phase: 1/2
Study Start date:
January 11, 2022
Estimated Completion Date:
August 31, 2029

Study Description

IL-2 is a key cytokine that directs the immune system through pleiotropic effects mediated by promoting expansion of both cytotoxic effector cells and Tregs. TransCon IL-2 β/γ is designed as a long-acting delivery prodrug of IL-2 β/γ, a potent cytokine signaling molecule, with the potential to improve the safety and efficacy of IL-2.

Connect with a study center

  • Ascendis Pharma Investigational Site

    Adelaide, 5000
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Adelaide 2078025, 5000
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Brisbane, 04120
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Brisbane 2174003, 04120
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Frankston, 3199
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Frankston 2166144, 3199
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Southport, 4215
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Southport 2148928, 4215
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Toorak Gardens, 05065
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Toorak Gardens 8348006, 05065
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Waratah, 2298
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Waratah 10103871, 2298
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Wilrijk, 2610
    Belgium

    Site Not Available

  • Ascendis Pharma Investigational Site

    Wilrijk 2783615, 2610
    Belgium

    Site Not Available

  • Ascendis Pharma Investigational Site

    Montreal 6077243, H4A 3J1
    Canada

    Site Not Available

  • Ascendis Pharma Investigational Site

    Montréal, H2X-0A9
    Canada

    Site Not Available

  • Ascendis Pharma Investigational Site

    Toronto, M5G 2C4
    Canada

    Site Not Available

  • Ascendis Pharma Investigational Site

    Toronto 6167865, M5G 2C4
    Canada

    Site Not Available

  • Ascendis Pharma Investigational Site

    Cuneo, 12100
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Cuneo 3177700, 12100
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Firenze, 50134
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Florence 3176959, 50134
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Grosseto, 58100
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Grosseto 3175786, 58100
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Lido Di Camaiore, 55041
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Lido di Camaiore 3174743, 55041
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Livorno, 57124
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Livorno 3174659, 57124
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Meldola, 47014
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Meldola 3173635, 47014
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Milan, 20133
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Milan 3173435, 20141
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Modena, 41124
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Modena 3173331, 41124
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Roma, 00167
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Roma 8957247, 00167
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Torino, 10126
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Torino 8980539, 10126
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Turin, 10060
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Turin 3165524, 10060
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Verona, 37134
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Verona 3164527, 37134
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Seongnam-si, 13620
    Korea, Republic of

    Site Not Available

  • Ascendis Pharma Investigational Site

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Ascendis Pharma Investigational Site

    Krakow 3094802, 31-501
    Poland

    Site Not Available

  • Ascendis Pharma Investigational Site

    Kraków, 31-501
    Poland

    Site Not Available

  • Ascendis Pharma Investigational Site

    Poznan 3088171, 60693
    Poland

    Site Not Available

  • Ascendis Pharma Investigational Site

    Poznań, 60693
    Poland

    Site Not Available

  • Ascendis Pharma Investigational Site

    Warsaw 756135, 02-781
    Poland

    Site Not Available

  • Ascendis Pharma Investigational Site

    Warszawa, 02-781
    Poland

    Site Not Available

  • Ascendis Pharma Investigational Site

    Singapore, 119228
    Singapore

    Site Not Available

  • Ascendis Pharma Investigational Site

    Singapore 1880252, 217562
    Singapore

    Site Not Available

  • Ascendis Pharma Investigational Site

    Seongnam-si 1897000, 13620
    South Korea

    Site Not Available

  • Ascendis Pharma Investigational Site

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Ascendis Pharma Investigational Site

    Barcelona, 08035
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    L'Hospitalet De Llobregat, 08908
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    L'Hospitalet de Llobregat 3120619, 08908
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Madrid, 28006
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Murcia, 30120
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Murcia 2513416, 30120
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Málaga, 29010
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Málaga 2514256, 29010
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Oviedo, 33011
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Oviedo 3114711, 33011
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Pamplona, 31008
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Pamplona 3114472, 31008
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Sevilla, 41014
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Seville 2510911, 41009
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Valencia, 46014
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Valencia 2509954, 46009
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Taipei, 10002
    Taiwan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Taipei 1668341, 10002
    Taiwan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Los Angeles, California 90048
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Springfield 4250542, Illinois 4896861 62702
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Morristown 5101427, New Jersey 5101760 07960
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    New York, New York 10032
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Huntersville 4472370, North Carolina 4482348 28078
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Canton, Ohio 44718
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Canton 5149222, Ohio 5165418 44718
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Oklahoma City 4544349, Oklahoma 4544379 73104
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Richmond 4781708, Virginia 6254928 23298
    United States

    Site Not Available

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