OncoMatch/Clinical Trials/NCT05473156
A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies
Is NCT05473156 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including AP203 and AP203 for locally advanced or metastatic solid tumors.
Treatment: AP203 · AP203 — This is a multi-regional, multi center, open label, first in human (FIH), dose-escalation, and dose-expansion study of AP203 to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and antitumor activities of AP203 in adult patients with locally advanced or metastatic solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Esophageal Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (TPS ≥ 1%) (TPS ≥ 1%)
Documented evidence of tumors expressing PD L1 (TPS ≥ 1%) for the determination of PD L1 expression in NSCLC
Required: PD-L1 (CD274) expression (CPS ≥ 1) (CPS ≥ 1)
Documented evidence of Combined Positive Score (CPS) ≥ 1 for PD L1
Required: EGFR wild-type
No sensitive epidermal growth factor receptor (EGFR) mutation
Required: ALK wild-type
No ... anaplastic lymphoma kinase (ALK) rearrangement
Required: ROS1 wild-type
No known actionable genomic alterations of ROS1 rearrangement
Required: BRAF wild-type
No known actionable genomic alterations of ... BRAF V600E mutation
Required: MET wild-type
No known actionable genomic alterations of ... MET mutation
Required: NTRK1 wild-type
No known actionable genomic alterations of ... NTRK1/2/3 gene fusion
Required: NTRK2 wild-type
No known actionable genomic alterations of ... NTRK1/2/3 gene fusion
Required: NTRK3 wild-type
No known actionable genomic alterations of ... NTRK1/2/3 gene fusion
Required: RET wild-type
No known actionable genomic alterations of ... RET rearrangement
Disease stage
Required: Stage LOCALLY UNRESECTABLE ADVANCED, IV
Metastatic disease required
locally unresectable advanced or metastatic solid tumors; at least 1 measurable lesion by RECIST v1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic treatment
received at least one line of systemic treatment including anti-PD-1 or anti-PD-L1 therapy
Must have received: anti-PD-1 therapy
received at least one line of systemic treatment including anti-PD-1 or anti-PD-L1 therapy
Must have received: anti-PD-L1 therapy
received at least one line of systemic treatment including anti-PD-1 or anti-PD-L1 therapy
Must have received: platinum-based chemotherapy or concurrent chemoradiation
Refractory or intolerant to platinum based chemotherapy or concurrent chemoradiation
Cannot have received: PD-L1 x CD137 bispecific antibody
prior therapy with any PD-L1 x CD137 bispecific antibody
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 × 10^9 /L; Platelet count ≥ 100 × 10^9 /L; Hemoglobin ≥ 9 g/dL
Kidney function
Estimated creatinine clearance > 50 mL/min (Cockcroft Gault formula)
Liver function
ALT and AST ≤ 2.5 × ULN or < 5 × ULN if hepatic metastases present; total bilirubin ≤ 1.5 × ULN (or < 3 × ULN for Gilbert's syndrome); alkaline phosphatase ≤ 2.5 × ULN or < 5 × ULN if bone metastases present
Participants with adequate organ function defined by the following: ... (see above for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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