NCT05081609

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Ascendis Pharma Oncology Division A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

IL-2 is a key cytokine that directs the immune system through pleiotropic effects mediated by promoting expansion of both cytotoxic effector cells and Tregs. TransCon IL-2 β/γ is designed as a long-acting delivery prodrug of IL-2 β/γ, a potent cytokine signaling molecule, with the potential to improve the safety and efficacy of IL-2.

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

Type	Name	Description
DRUG	TransCon IL-2 β/γ	TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
DRUG	Pembrolizumab	Pembrolizumab will be administered as an intravenous (IV) infusion
DRUG	Chemotherapy drug	SOC chemotherapy will be administered as an intravenous (IV) infusion
DRUG	TransCon TLR7/8 Agonist	TransCon TLR7/8 Agonist will be administered as an IT (Intratumoral) injection
PROCEDURE	Surgery	Surgery will take place 4-6 weeks after last dose of study treatment.
DRUG	Trastuzumab	Trastuzumab will be administered as an intravenous (IV) infusion
DRUG	Trastuzumab emtansine (T-DM1)	Trastuzumab emtansine (T-DM1) will be administered as an intravenous (IV) infusion

Timeline

• Start date: 2022-01-11
• Primary completion: 2027-08-01
• Completion: 2029-08-01
• First posted: 2021-10-18
• Last updated: 2026-02-24

Locations

68 sites across 10 countries: United States, Australia, Belgium, Canada, Italy, Poland, Singapore, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study