ArticleThe oncologist2026
Phase I study of Y101D, a bispecific antibody targeting PD-L1 and TGF-β in patients with advanced solid tumors.
Article in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05028556 (A Phase 1, Multicenter, Open-label, Dose-increasing Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of Y101D, a Recombinant Anti-PD-L1 and TGF-β Bispecific Antibody for Injection, in Patients With Metastatic or Locally Advanced Solid Tumors), which is not on this map. Cited by 1 paper.
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A Phase 1, Multicenter, Open-label, Dose-increasing Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of Y101D, a Recombinant Anti-PD-L1 and TGF-β Bispecific Antibody for Injection, in Patients With Metastatic or Locally Advanced Solid Tumors
Who cites it
1 citing paper in PubMed.
- The Five-Decade Journey of Small Cell Lung Cancer.Cancer communications (London, England) · 2026Review
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17 authors.
Funding
Abstract
backgroundY101D is a novel bispecific antibody targeting PD-L1 and TGF-β. This multicenter phase I study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of Y101D in patients with metastatic or locally advanced solid tumors.
methodsPatients who failed standard therapies were enrolled. In the dose-escalation and -expansion phases, Y101D was administered intravenously every 2 weeks (Q2W) at 1, 3, 10, 20, and 30 mg/kg. Primary objectives were dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) in escalation, safety, and objective response rate (ORR) in expansion. Secondary objectives included pharmacokinetics/pharmacodynamics parameters, and immunogenicity.
resultsAmong 50 enrolled patients, the most common treatment-related adverse events (TRAEs) were aspartate aminotransferase elevation (20.0%), gingival bleeding (18.0%), alanine aminotransferase elevation (14.0%), rash (14.0%), and proteinuria (14.0%). Grade ≥ 3 TRAEs occurred in 10.0% of patients, with no grade 4/5 TRAEs. Immune-related adverse events (irAEs) occurred in 22.0%, predominantly grades 1-2. No DLTs were observed, and MTD was not reached. One extensive-stage small cell lung cancer (ES-SCLC) patient (20 mg/kg Q2W) achieved a confirmed partial response (ORR: 2.1%, 95% CI, 0.1%-11.3%). Median progression-free survival and overall survival were 1.3 months (95% CI, 0.9-1.3) and 10.5 months (95% CI, 6.6-12.7), respectively. The pharmacokinetic characteristics of single and multiple doses of 20 mg/kg Q3W and 1200 mg Q3W supported the administration schedule of once every 3 weeks. PD-L1 target occupancy exceeded 95% at 2 h post-dose across all cohorts and remained sustained pre-dose.
conclusionsY101D monotherapy exhibited a manageable safety profile and on-target pharmacodynamic activity, with limited antitumor activity as a single agent. Further evaluation in disease-focused cohorts and rational combination regimens is warranted, including in ES-SCLC. CLINICAL TRIAL NUMBER REGISTRATION: NCT05028556.
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