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ACTIVE NOT RECRUITING Phase 1

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

NCT05081609 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Pembrolizumab
  • PROCEDURE Surgery
  • DRUG Chemotherapy drug
  • DRUG TransCon IL-2 β/γ
  • DRUG TransCon TLR7/8 Agonist

Study Locations (20)

Other

  • Ascendis Pharma Investigational Site — Adelaide
  • Ascendis Pharma Investigational Site — Adelaide
  • Ascendis Pharma Investigational Site — Brisbane
  • Ascendis Pharma Investigational Site — Frankston
  • Ascendis Pharma Investigational Site — Southport
  • Ascendis Pharma Investigational Site — Toorak Gardens

California

  • Ascendis Pharma Investigational Site — Los Angeles
  • Ascendis Pharma Investigational Site — Los Angeles

Ohio

  • Ascendis Pharma Investigational Site — Canton
  • Ascendis Pharma Investigational Site — Cincinnati

Illinois

  • Ascendis Pharma Investigational Site — Springfield

Kentucky

  • Ascendis Pharma Investigational Site — Louisville

Massachusetts

  • Ascendis Pharma Investigational Site — Boston

New Jersey

  • Ascendis Pharma Investigational Site — Morristown

New York

  • Ascendis Pharma Investigational Site — New York

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2022-01-11
Est. Completion 2029-08
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05081609

The ClinicalTrials.gov registry entry for NCT05081609 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ascendis Pharma Oncology Division A/S, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05081609 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05081609 about?

NCT05081609 is a clinical study titled "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 wit...

What is the current status of trial NCT05081609?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 320 participants. The study started on 2022-01-11. Estimated completion is 2029-08.

What conditions does trial NCT05081609 study?

This clinical trial studies the following conditions: Advanced Solid Tumor, Metastatic Solid Tumor, Locally Advanced Solid Tumor, Platinum-resistant Ovarian Cancer, Post Anti-PD-1 Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05081609?

The interventions under investigation include: Pembrolizumab (DRUG), Surgery (PROCEDURE), Chemotherapy drug (DRUG), TransCon IL-2 β/γ (DRUG), TransCon TLR7/8 Agonist (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05081609?

This trial is sponsored by Ascendis Pharma Oncology Division A/S, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05081609 being conducted?

This trial has 20 study locations across California, Illinois, Kentucky, Massachusetts, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial