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
Public ClinicalTrials.gov record NCT05081609. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05081609
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 320 participants
Conditions and interventions
Conditions
- Advanced Solid Tumor
- Locally Advanced Solid Tumor
- Metastatic Solid Tumor
- Platinum-resistant Ovarian Cancer
- 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
- Third Line or Later (3L+) HER2+ Breast Cancer
- Second or Third Line (2L/3L) Cervical Cancer
- Third-line or Later (3L+) Platinum-resistant Ovarian Cancer (PROC)
Interventions
- TransCon IL-2 β/γ Drug
- Pembrolizumab Drug
- Chemotherapy drug Drug
- TransCon TLR7/8 Agonist Drug
- Surgery Procedure
- Trastuzumab Drug
- Trastuzumab emtansine (T-DM1) Drug
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 11, 2022 (Actual)
- Primary completion
- Aug 2027 (Estimated)
- Completion
- Aug 2029 (Estimated)
- Last update posted
- Oct 13, 2026
2022 – 2029
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ascendis Pharma Investigational Site | Los Angeles | California | 90048 | — |
| Ascendis Pharma Investigational Site | Los Angeles | California | 90067 | — |
| Ascendis Pharma Investigational Site | Springfield | Illinois | 62702 | — |
| Ascendis Pharma Investigational Site | Louisville | Kentucky | 40202 | — |
| Ascendis Pharma Investigational Site | Boston | Massachusetts | 02114 | — |
| Ascendis Pharma Investigational Site | Morristown | New Jersey | 07960 | — |
| Ascendis Pharma Investigational Site | New York | New York | 10032 | — |
| Ascendis Pharma Investigational Site | Huntersville | North Carolina | 28078 | — |
| Ascendis Pharma Investigational Site | Canton | Ohio | 44718 | — |
| Ascendis Pharma Investigational Site | Cincinnati | Ohio | 45219 | — |
| Ascendis Pharma Investigational Site | Oklahoma City | Oklahoma | 73104 | — |
| Ascendis Pharma Investigational Site | Pittsburgh | Pennsylvania | 15232 | — |
| Ascendis Pharma Investigational Site | Nashville | Tennessee | 37203 | — |
| Ascendis Pharma Investigational Site | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 54 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05081609, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05081609 live on ClinicalTrials.gov.