Trial results for pegilodecakin in participants with advanced solid tumors were posted on 2026-07-09. The PHASE1 study (NCT02009449) evaluated the safety and tolerability of pegilodecakin as monotherapy or in combination, reporting up to 116 participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in one dose group.

Background

Pegilodecakin (LY3500518) was investigated in this study for participants with advanced solid tumors, including Melanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma, and Colorectal Carcinoma. This first-in-human study aimed to assess its safety and tolerability.

Trial design

The study, identified as NCT02009449, was conducted as an open-label, dose escalation PHASE1 trial. It enrolled 353 participants with advanced solid tumors, including Melanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma, and Colorectal Carcinoma. The interventions included pegilodecakin administered daily subcutaneously as a monotherapy or in combination with chemotherapy regimens such as paclitaxel or docetaxel and carboplatin or cisplatin, folfox (oxaliplatin/leucovorin/5-fluorouracil), gemcitabine/nab-paclitaxel, and capecitabine. The study's primary objective was to evaluate the safety and tolerability of pegilodecakin.

Key results

Safety outcomes were reported as the number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) observed during the study of pegilodecakin. In Part A (monotherapy), the counts were: 4 participants for Pegilodecakin 0.08/0.1 mg, 6 participants for Pegilodecakin 0.2/0.25 mg, 6 participants for Pegilodecakin 0.4/0.5 mg, 6 participants for Pegilodecakin 0.8/1 mg, 116 participants for Pegilodecakin 1.6/2 mg, and 5 participants for Pegilodecakin 3.2/4 mg.

In combination therapy arms, the counts were: 4 participants for Pegilodecakin 0.2/0.25 mg + Platinum/Taxane, 3 participants for Pegilodecakin 0.4/0.5 mg + Platinum/Taxane, and 18 participants for Pegilodecakin 0.8/1 mg + Platinum/Taxane.

For combinations with FOLFOX, the counts were: 4 participants for Pegilodecakin 0.2/0.25 mg + FOLFOX, 29 participants for Pegilodecakin 0.4/0.5 mg + FOLFOX, and 6 participants for Pegilodecakin 0.8/1 mg + FOLFOX.

What this means

The results from this PHASE1 dose escalation study provide initial insights into the safety and tolerability of pegilodecakin in participants with advanced solid tumors. The reported counts of TEAEs and SAEs across different monotherapy and combination dose groups are crucial for understanding the drug's safety profile. This data helps in identifying dose ranges and potential adverse event patterns, which are essential for guiding further clinical development and dose selection in subsequent phases of investigation for pegilodecakin.

Source

These trial results were posted on ClinicalTrials.gov on 2026-07-09. The full details of the study, NCT02009449, are available on clinicaltrials.gov.