ILKN421H Plus Pembrolizumab in Advanced Non-Small Cell Lung Cancer

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ILKN421H — DRUG
  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.
• Pembrolizumab — DRUG
  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

Study Details

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.

Key Dates

First listed

Mar 5, 2026

Start date

Jun 29, 2026

Status verified

Jul 2026

Primary completion

Jun 30, 2029

Completion

Oct 31, 2029

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: 1.6 mg ILKN421H + 200 mg pembrolizumab，2L/2L+ Post-IO NSCLC with all PD-L1 level
  1.6 mg of ILKN421H in combination of 200 mg pembrolizumab with i.v. infusion Q3W in participants with 2L/2L+, post-IO NSCLC regardless of PD-L1 level
• Experimental: 2.4 mg ILKN421H + 200 mg pembrolizumab，2L/2L+ Post-IO NSCLC with all PD-L1 level
  2.4 mg of ILKN421H in combination of 200 mg pembrolizumab with i.v. infusion Q3W in participants with 2L/2L+, post-IO NSCLC regardless of PD-L1 level
• Experimental: 1.6 mg ILKN421H + 200 mg pembrolizumab，1L NSCLC with PD-L1 TPS ≥1%
  1.6 mg of ILKN421H in combination with 200 mg pembrolizumab in 1L NSCLC with PD-L1 TPS ≥1%
• Experimental: 2.4 mg ILKN421H + 200 mg pembrolizumab，1L NSCLC with PD-L1 TPS ≥1%
  2.4 mg of ILKN421H in combination with 200 mg pembrolizumab in 1L NSCLC with PD-L1 TPS ≥1%

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. [ Time Frame: Up to 3 years. ]

Central Contacts

• Haining Huang
  858-209-6722
  [email protected]

Locations (2)

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