OncoMatch/Clinical Trials/NCT05753722
A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies
Is NCT05753722 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including PRTH-101 and Pembrolizumab for advanced or metastatic solid tumors.
Treatment: PRTH-101 · Pembrolizumab — The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Small Cell Lung Cancer
Non-Small Cell Lung Carcinoma
Disease stage
Metastatic disease required
metastatic or advanced, unresectable malignancy and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: within 28 days or five half-lives of the drug, whichever is shorter
Subject has received prior treatment with systemic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines, and monoclonal antibodies (e.g., checkpoint inhibitors) within 28 days or five half-lives of the drug, whichever is shorter.
Cannot have received: radiation therapy
Exception: limited (e.g., pain palliation) radiation therapy is allowed prior to and during study treatment as long as there are no acute toxicities, and the subject has measurable disease outside the radiation field
Subject has received radiation therapy <28 days prior to administration of PRTH-101.
Lab requirements
Blood counts
Hemoglobin ≥9.0 g/dL; Platelets ≥100 × 10^9 cells/L; Absolute neutrophil count ≥1.5 ×10^9 cells/L (without the use of hematopoietic growth factors)
Kidney function
Calculated creatinine clearance must be ≥30 mL/min by Cockcroft-Gault formula calculation
Liver function
Total bilirubin ≤1.5 × ULN unless has known history of Gilbert's syndrome (≤3 × ULN); AST and ALT ≤1.5 × ULN, or ≤3 x ULN in the presence of liver metastases
Cardiac function
Corrected QT interval (QTc) ≤470 milliseconds (as calculated by the Fridericia correction formula)
Subject must have the following laboratory values (obtained ≤14 days prior to enrollment): Calculated creatinine clearance must be ≥30 mL/min by Cockcroft-Gault formula calculation; Total bilirubin ≤1.5 × ULN unless has known history of Gilbert's syndrome (≤3 × ULN); AST and ALT ≤1.5 × ULN, or ≤3 x ULN in the presence of liver metastases; Hemoglobin ≥9.0 g/dL; Platelets ≥100 × 10^9 cells/L; Absolute neutrophil count ≥1.5 ×10^9 cells/L (without the use of hematopoietic growth factors); Corrected QT interval (QTc) ≤470 milliseconds (as calculated by the Fridericia correction formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Honor Health Research Institute · Scottsdale, Arizona
- Yale Cancer Center · New Haven, Connecticut
- Mass General Cancer Center · Boston, Massachusetts
- Providence Cancer Institute Franz Clinic · Portland, Oregon
- University of Pittsburgh Medical Center Hillman Cancer Center · Pittsburgh, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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