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Clinical Trials in the USA / NCT05081609
Active, not recruiting Phase 1/Phase 2

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 · tracked via the Priya Life Science USA tracker
Sponsor
Ascendis Pharma Oncology Division A/S
Phase
Phase 1/Phase 2
Started
2022-01-11
Last updated
2026-09-11

Condition(s) studied

Advanced Solid TumorLocally Advanced Solid TumorMetastatic Solid TumorPlatinum-resistant Ovarian CancerPost Anti-PD-1 Melanoma2L+ Cervical CancerNeoadjuvant MelanomaNeoadjuvant Non-Small Cell Lung CancerPost Anti-PD-(L)1 Non-Small Cell Lung CancerPost Anti-PD-(L)1 Small Cell Lung CancerThird Line or Later (3L+) HER2+ Breast CancerSecond or Third Line (2L/3L) Cervical CancerThird-line or Later (3L+) Platinum-resistant Ovarian Cancer (PROC)

Investigational drug(s) / intervention(s)

TransCon IL-2 β/γPembrolizumabChemotherapy drugTransCon TLR7/8 AgonistSurgeryTrastuzumabTrastuzumab emtansine (T-DM1)

TransCon IL-2 β/γ: TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion

Pembrolizumab: Pembrolizumab will be administered as an intravenous (IV) infusion

Chemotherapy drug: SOC chemotherapy will be administered as an intravenous (IV) infusion

TransCon TLR7/8 Agonist: TransCon TLR7/8 Agonist will be administered as an IT (Intratumoral) injection

Surgery: Surgery will take place 4-6 weeks after last dose of study treatment.

Trastuzumab: Trastuzumab will be administered as an intravenous (IV) infusion

Trastuzumab emtansine (T-DM1): Trastuzumab emtansine (T-DM1) will be administered as an intravenous (IV) infusion

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (68)

FacilityCityRegionStatus
Ascendis Pharma Investigational Site Los Angeles California
Ascendis Pharma Investigational Site Los Angeles California
Ascendis Pharma Investigational Site Springfield Illinois
Ascendis Pharma Investigational Site Louisville Kentucky
Ascendis Pharma Investigational Site Boston Massachusetts
Ascendis Pharma Investigational Site Morristown New Jersey
Ascendis Pharma Investigational Site New York New York
Ascendis Pharma Investigational Site Huntersville North Carolina
Ascendis Pharma Investigational Site Canton Ohio
Ascendis Pharma Investigational Site Cincinnati Ohio
Ascendis Pharma Investigational Site Oklahoma City Oklahoma
Ascendis Pharma Investigational Site Pittsburgh Pennsylvania
Ascendis Pharma Investigational Site Nashville Tennessee
Ascendis Pharma Investigational Site Richmond Virginia
Ascendis Pharma Investigational Site Adelaide Australia
Ascendis Pharma Investigational Site Adelaide Australia
Ascendis Pharma Investigational Site Brisbane Australia
Ascendis Pharma Investigational Site Frankston Australia
Ascendis Pharma Investigational Site Southport Australia
Ascendis Pharma Investigational Site Toorak Gardens Australia
Ascendis Pharma Investigational Site Waratah Australia
Ascendis Pharma Investigational Site Wilrijk Belgium
Ascendis Pharma Investigational Site Montreal Canada
Ascendis Pharma Investigational Site Toronto Canada
Ascendis Pharma Investigational Site Toronto Canada
Ascendis Pharma Investigational Site Cuneo Italy
Ascendis Pharma Investigational Site Florence Italy
Ascendis Pharma Investigational Site Grosseto Italy
Ascendis Pharma Investigational Site Lido di Camaiore Italy
Ascendis Pharma Investigational Site Livorno Italy
Ascendis Pharma Investigational Site Meldola Italy
Ascendis Pharma Investigational Site Milan Italy
Ascendis Pharma Investigational Site Milan Italy
Ascendis Pharma Investigational Site Modena Italy
Ascendis Pharma Investigational Site Roma Italy
Ascendis Pharma Investigational Site Torino Italy
Ascendis Pharma Investigational Site Turin Italy
Ascendis Pharma Investigational Site Verona Italy
Ascendis Pharma Investigational Site Krakow Poland
Ascendis Pharma Investigational Site Poznan Poland

+ 28 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05081609 on ClinicalTrials.gov ↗ ← All trials in the USA