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NCT05081609 · ClinicalTrials.gov registry record · 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

A Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor, sponsored by Ascendis Pharma Oncology Division A/S.

Active
Registry status
Phase 1
Development phase
320
Enrollment target
20
Study locations

NCT05081609: Active Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor, sponsored by Ascendis Pharma Oncology Division A/S.

NCT05081609 is a Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor that is active but no longer recruiting, run by Ascendis Pharma Oncology Division A/S. The registered enrollment target is 320 participants, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (68% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05081609, a Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor, is active but no longer recruiting, sponsored by Ascendis Pharma Oncology Division A/S.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
320 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Treatment emergent and treatment related adverse events (assessed by NCI CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation, deaths.

Conditions Studied

Advanced Solid Tumor Metastatic Solid Tumor Platinum-resistant Ovarian Cancer Locally Advanced Solid Tumor Post Anti-PD-1 Melanoma 2L+ Cervical Cancer Neoadjuvant Melanoma Neoadjuvant Non-Small Cell Lung Cancer Post Anti-PD-(L)1 Non-Small Cell Lung Cancer Post Anti-PD-(L)1 Small Cell Lung Cancer

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
Ascendis Pharma Oncology Division A/S

2 total trials

What the registry record for NCT05081609 still lists

NCT05081609 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (68% higher).

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.

NCT05081609 names 20 study sites across 13 states, led by Other, California, Ohio.

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, Platinum-resistant Ovarian Cancer, Locally Advanced Solid Tumor, Post Anti-PD-1 Melanoma.

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).

Who is sponsoring clinical trial NCT05081609?

This trial is sponsored by Ascendis Pharma Oncology Division A/S, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05081609's enrollment target sits among peer trials

320 30th of 189 higher than 159 of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05081609, the US trial registry maintained by the National Library of Medicine. NCT05081609 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.