Pembrolizumab/NT-I7 Combination Shows Dose-Dependent TEAEs in Solid Tumors

Trial results for the Phase 1b/2a study (NCT04332653) investigating pembrolizumab in combination with NT-I7 (Efineptakin Alfa) in participants with advanced solid tumors were posted on ClinicalTrials.gov on 2026-02-09. The study's Phase 1b results indicated that 6 participants experienced treatment emergent adverse events (TEAEs) at the highest dose level of NT-I7 1200 ug/kg.

Background

The study, titled "NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors," aimed to evaluate the safety, tolerability, and preliminary anti-tumor activity of the combination therapy. Specifically, Phase 1b focused on determining the safety and tolerability of NT-I7 in combination with pembrolizumab, as well as identifying the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D).

Trial design

The study (NCT04332653) was a Phase 1b/2a trial that enrolled 215 participants with advanced solid tumors, including Triple Negative Breast Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, and Microsatellite Stable Colorectal Cancer. The interventions investigated were NT-I7 (Efineptakin Alfa) in combination with pembrolizumab (Keytruda®). The Phase 1b portion of the study focused on assessing the safety and tolerability of the combination across different dose levels of NT-I7.

Key results

The Phase 1b results focused on the safety and tolerability profile of NT-I7 in combination with pembrolizumab across different dose levels. The outcome measured was the "Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs."

• At Phase 1b: Dose Level 1 (NT-I7 480 ug/kg):
  • 3 participants experienced Treatment Emergent Adverse Events (TEAEs).
  • 2 participants experienced Serious Adverse Events (SAEs).
  • 3 participants experienced Trial Treatment-related TEAEs.
  • 1 participant experienced Trial Treatment-related SAEs.
• At Phase 1b: Dose Level 2 (NT-I7 960 ug/kg):
  • 3 participants experienced Treatment Emergent Adverse Events (TEAEs).
  • 1 participant experienced Serious Adverse Events (SAEs).
  • 2 participants experienced Trial Treatment-related TEAEs.
  • 0 participants experienced Trial Treatment-related SAEs.
• At Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg):
  • 6 participants experienced Treatment Emergent Adverse Events (TEAEs).
  • 1 participant experienced Serious Adverse Events (SAEs).
  • 6 participants experienced Trial Treatment-related TEAEs.
  • 0 participants experienced Trial Treatment-related SAEs.

What this means

The posted Phase 1b results provide initial insights into the safety and tolerability profile of NT-I7 in combination with pembrolizumab in participants with advanced solid tumors. The data indicates that treatment emergent adverse events (TEAEs) and trial treatment-related TEAEs were observed across all tested dose levels, with the highest number of participants experiencing these events at the NT-I7 1200 ug/kg dose level. Serious adverse events (SAEs) and trial treatment-related SAEs were also reported, though not consistently increasing with dose. These findings are crucial for determining the maximum tolerated dose and recommended Phase 2 dose for further investigation into the combination's efficacy.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04332653, titled "NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors," were posted on 2026-02-09 on clinicaltrials.gov.