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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 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.

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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.

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

Sponsor

Ascendis Pharma Oncology Division A/S

2 total trials

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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, categorized as Phase 1. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (68% higher). The listed sponsor is Ascendis Pharma Oncology Division A/S, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.