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

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

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 / Drugs

TransCon IL-2 β/γ Pembrolizumab Chemotherapy drug TransCon TLR7/8 Agonist Surgery Trastuzumab Trastuzumab emtansine (T-DM1)

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment320 participants

Primary Completion—

Lead SponsorAscendis Pharma Oncology Division A/S

Data Retrieved2026-04-11 02:54:40.919310+00:00

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