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: May 1, 2025
Sponsor: Ascendis Pharma Oncology Division A/S
Overall Status: Active - Recruiting

Phase

1/2

Condition

Cervical Cancer

Small Cell Lung Cancer

Melanoma

Treatment

TransCon TLR7/8 Agonist

Pembrolizumab

Chemotherapy drug

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: 345
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, 5042
    Australia

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Frankston, 3199
    Australia

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Southport, 4215
    Australia

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Toorak Gardens, 05065
    Australia

    Terminated

  • Ascendis Pharma Investigational Site

    Waratah, 2298
    Australia

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Wilrijk, 2610
    Belgium

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Montréal, H2X-0A9
    Canada

    Site Not Available

  • Ascendis Pharma Investigational Site

    Toronto, M5G 2C4
    Canada

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Cuneo, 12100
    Italy

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Firenze, 50134
    Italy

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Grosseto, 58100
    Italy

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Lido Di Camaiore, 55041
    Italy

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Livorno, 57124
    Italy

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Meldola, 47014
    Italy

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Milan, 20141
    Italy

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Modena, 41124
    Italy

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Roma, 00167
    Italy

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Torino, 10126
    Italy

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Turin, 10060
    Italy

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Verona, 37134
    Italy

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Seongnam-si, 13620
    Korea, Republic of

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Kraków, 31-501
    Poland

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Poznań, 60693
    Poland

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Warszawa, 02-781
    Poland

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Singapore, 217562
    Singapore

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    L'Hospitalet De Llobregat, 08908
    Spain

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Madrid, 28041
    Spain

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Murcia, 30120
    Spain

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Málaga, 29010
    Spain

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Oviedo, 33011
    Spain

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Sevilla, 41014
    Spain

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Valencia, 46014
    Spain

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Taipei, 11259
    Taiwan

    Terminated

  • Ascendis Pharma Investigational Site

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Springfield, Illinois 62702
    United States

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    New York, New York 10032
    United States

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Huntersville, North Carolina 28078
    United States

    Terminated

  • Ascendis Pharma Investigational Site

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Ascendis Pharma Investigational Site

    Richmond, Virginia 23298
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.