Active Not RecruitingPhase 1 / Phase 2NCT05081609

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

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.

Checked against the public recordLast updated Feb 24, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 1 / Phase 2
U.S. locations68
SponsorAscendis Pharma Oncology Division A/S
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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Ascendis Pharma Oncology Division A/S
Interventions being studied
Drug: TransCon IL-2 β/γ; Drug: Pembrolizumab; Drug: Chemotherapy drug; Drug: TransCon TLR7/8 Agonist; Procedure: Surgery; Drug: Trastuzumab; Drug: Trastuzumab emtansine (T-DM1)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • Ascendis Pharma Investigational SiteLos Angeles, California
  • Ascendis Pharma Investigational SiteLos Angeles, California
  • Ascendis Pharma Investigational SiteSpringfield, Illinois
  • Ascendis Pharma Investigational SiteLouisville, Kentucky
  • Ascendis Pharma Investigational SiteBoston, Massachusetts
  • Ascendis Pharma Investigational SiteMorristown, New Jersey
  • Ascendis Pharma Investigational SiteNew York, New York
  • Ascendis Pharma Investigational SiteHuntersville, North Carolina
  • Ascendis Pharma Investigational SiteCanton, Ohio
  • Ascendis Pharma Investigational SiteCincinnati, Ohio
  • Ascendis Pharma Investigational SiteOklahoma City, Oklahoma
  • Ascendis Pharma Investigational SitePittsburgh, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 24, 2026. Always confirm current availability with the study team.

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