REGN10597 / Regeneron - LARVOL DELTA

A phase 1/2 dose-escalation/expansion study of REGN10597 (anti–PD-1–IL2Rα-IL2) in patients with advanced solid tumors. (ASCO 2026) - P1/2 | "Aldesleukin, an approved recombinant high-dose IL-2 therapy, has shown complete and durable responses in some cases; however, high-dose IL-2 is associated with severe toxicity, including vascular leak syndrome and pulmonary edema. Secondary endpoints for both phases include additional efficacy measures (best overall response, duration of response, disease control rate, time to response, and progression-free survival, all per RECIST 1.1), and pharmacokinetics and immunogenicity of REGN10597. Trial enrollment for the dose escalation phase began on October 1, 2024; as of January 27, 2026, 22 patients have been enrolled."

Clinical • First-in-human • Metastases • P1/2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Melanoma • Oncology • Respiratory Diseases • Solid Tumor • IL2 • IL2RA

R10597-ONC-22114: A First-In-Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination with Cemiplimab Works in Adult Participants Who Have Cancer with Tumors that Have Spread in Their Body (clinicaltrialsregister.eu) - P1/2 | N=52 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals Inc.

First-in-human • New P1/2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor

Phase 1/2 dose escalation/expansion study of REGN10597 (anti–PD-1–IL2Rα-IL2) in patients with advanced solid tumors. (ASCO-GU 2026) - P1/2 | "Aldesleukin, an approved recombinant high-dose IL-2 therapy, has shown complete and durable responses in some cases; however, high-dose IL-2 is associated with severe toxicity, including vascular leak syndrome and pulmonary edema. Secondary endpoints for both phases include additional efficacy measures (best overall response, duration of response, disease control rate, time to response, and progression-free survival, all per RECIST v1.1), and pharmacokinetics and immunogenicity of REGN10597. Trial enrollment for the dose escalation phase began on October 1, 2024; as of October 21, 2025, 18 patients have been enrolled."

Clinical • First-in-human • Metastases • P1/2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • IL2 • IL2RA

A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body (clinicaltrials.gov) - P1/2 | N=240 | Recruiting | Sponsor: Regeneron Pharmaceuticals | N=150 ➔ 240

Enrollment change • First-in-human • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor

A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor

A First-In Human (FIH) Trial to Find Out if REGN10579 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies (clinicaltrials.gov) - P1/2 | N=150 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

Metastases • New P1/2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor