ArticleCancer immunology, immunotherapy : CII2026
A phase I study evaluating subcutaneous administration of the monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283) in patients with advanced solid malignancies.
Article in Cancer immunology, immunotherapy : CII, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02908906 (63723283LUC1001), which is not on this map. Not yet cited in PubMed.
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63723283LUC1001: A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Cancers
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Abstract
purposePharmacokinetics, pharmacodynamics, safety, and efficacy of subcutaneous cetrelimab were assessed in Parts (P)3 and 4 of the phase I LUC1001 study in patients with advanced/refractory solid tumors who progressed on or wereineligible for standard treatment and had no prior PD-1/PD-L1/PD-L2 treatment.
methodsIn P3, low-concentration cetrelimab (30 mg/mL) was administered subcutaneously at 600 mg with a 6-week interval between doses 1 and 2, then every 3 weeks (Q3W). Based on P3 pharmacokinetic and safety findings, high-concentration cetrelimab (150 mg/mL) was administered subcutaneously at a 900 mg loading dose followed by 600 mg Q3W in P4.
resultsAmong 30 enrolled patients (P3, n = 11; P4, n = 19), median age was 54.5y; 76.7% received ≥ 3 prior lines of therapy. Median duration of treatment was 2.1mo. Treatment-related adverse events (AEs) occurred in 70% of patients, including 23.3% with grade ≥ 3 treatment-related AEs and 30.0% immune-related AEs; no treatment-related serious AEs or systemic infusion-related reactions occurred. After 3.7mo median follow-up, 2 patients (6.7%) achieved durable responses and 4 patients (13.3%) had stable disease for ≥ 24 weeks. Pharmacokinetic data showed that adding a 900 mg loading dose to the 600 mg Q3W subcutaneous regimen shortened the time to reach target recommended phase 2 dose (RP2D) exposures, making it a suitable intravenous alternative. Maximum PD-1 receptor occupancy was achieved with both formulations. Anti-cetrelimab antibodies were detected in 4 patients (13.3%); none were neutralizing.
conclusionsRP2D of subcutaneous cetrelimab was established as a loading dose of 900 mg followed by 600 mg Q3W. Subcutaneous cetrelimab demonstrated characteristics consistent with prior characterization of intravenous cetrelimab. Trial registration NCT02908906 at ClinicalTrials.gov, September 21, 2016; EudraCT 2016-002,017-22 at clinicaltrialsregister.eu, Jan 11, 2017.
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