MedTrace Logo

ILKN421H Plus Pembrolizumab in Advanced Non-Small Cell Lung Cancer

NCT07452224 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-12

No results posted yet for this study

Summary

This is a multicenter, open-label, phase II study to evaluate the safety, tolerability, clinical activity, and pharmacokinetics of ILKN421H in combination with pembrolizumab in participants with locally advanced or metastatic NSCLC.

The study consists of 4 cohorts in participants with locally advanced or metastatic NSCLC ( squamous \[sq\] or non-squamous \[non-sq\]) without functional genomic alterations including EGFR, ALK and Ros-1, who failed systemic PD-1/L1 inhibitor treatment either alone or in combination with standard chemotherapy (post-IO) (Cohort 1 and 2), or without any prior systemic anti-cancer therapy (1L) with PDL-1 TPS ≥1% (Cohort 3 and 4). Participants will be dosed either with 1.6 mg of ILKN421H (Cohort 1 and Cohort 3) or 2.4 mg of ILKN421H (Cohort 2 and Cohort 4) in combination with 200 mg pembrolizumab. Both treatments will be administered through intravenous (i.v.) infusion every 3 weeks (Q3W) on Day 1 of each cycle with 21-day as one cycle, while ILKN421H will be dosed 4 hours after pembrolizumab. All 4 cohorts will have 3 study periods:

* Screening Period: ≤ 28 days prior to first dose of study treatment;
* Treatment period: 21-day cycles until unacceptable toxicity, lost to follow-up, disease progression, withdrawal of consent, death, or the sponsor closes the study, whichever occurs first;
* Follow-up Period: 30-day safety follow-up and a Long-Term follow-up every 6-month for survival information.

Conditions

  • Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Interventions

DRUG

ILKN421H

Participants will receive ILKN421H in combination with pembrolizumab once every 3 weeks (Q3W). ILKN421H will be administered via i.v. infusion, starting at a rate of 75 mL/h for the first 20 minutes. If no infusion-related reactions are observed, the infusion rate can be increased to 150 mL/h for the remainder of the infusion.

DRUG

Pembrolizumab

Pembrolizumab will be administered intravenously first. After the infusion ends, at least 4 hours must pass before the intravenous infusion of ILKN421H can begin. Each infusion will last for 1 hour, and the infusion rate will follow the same guidelines

Sponsors & Collaborators

  • iLeukon Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-06-30
Completion
2029-10-31
FDA Drug
Yes

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07452224 on ClinicalTrials.gov