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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Safety and Tolerability — Through study completion, expected average of 2 years
Treatment emergent and treatment related adverse events (assessed by NCI CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation, deaths. - Maximum Tolerated Dose (MTD) — Each cycle is 21 days
Determine the maximum tolerated dose by assessing the Incidence of Dose Limiting Toxicities (DLTs), treatment emergent and treatment related adverse events (assessed by NCI CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation and deaths. - Recommended Phase 2 Dose (RP2D) — 12 months
To determine a recommended phase 2 dose of TransCon IL-2 β/γ and combination regimen for further development by evaluating number of patients with treatment-related adverse events as assessed by CTCAE.
Trial sites (68)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
Other trials for the same condition
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 Spain