onvapegleukin alfa (TransCon IL-2 β/γ)

P2, N=27, Active, not recruiting, Ascendis Pharma A/S | Recruiting --> Active, not recruiting | N=92 --> 27

P1/2, N=473, Recruiting, Ascendis Pharma Oncology Division A/S | Trial completion date: Aug 2027 --> Aug 2029 | Trial primary completion date: May 2026 --> Aug 2027

P1/2, N=393, Recruiting, Ascendis Pharma Oncology Division A/S | Trial completion date: May 2025 --> Aug 2027 | Trial primary completion date: Jan 2025 --> May 2026

The RP2D for monotherapy was determined at 120 mcg/kg IV every 3 weeks while dose escalation continues for combination therapy. PK data indicated a half-life of at least 35 hours and PD data confirm durable activation and expansion of cytotoxic immune cells from TransCon IL-2 β/γ.

Recombinant human interleukin-2 (IL-2, aldesleukin) can induce a response rate of ̃15% in metastatic renal cell carcinoma and metastatic melanoma, yet toxicities (vascular leak syndrome, cytokine storm) have limited its use...Parts 1 and 2 Dose Escalation (Phase 1) use a standard 3+3 design with increasing doses of intravenous (IV) TransCon IL-2 b/g alone (Part 1) or with 200 mg IV pembrolizumab in solid tumors where pembrolizumab monotherapy may have clinical activity (Part 2)...Other key objectives include the evaluation of pharmacokinetics, pharmacodynamic biomarkers, and antitumor activity according to RECIST 1.1. Recruitment started in January 2022 and is ongoing (NCT05081609).

P1/2, N=86, Recruiting, Ascendis Pharma Oncology Division A/S | Not yet recruiting --> Recruiting

P1/2, N=86, Not yet recruiting, Ascendis Pharma A/S