OncoMatch/Clinical Trials/NCT05076396
PM14 Administered Intravenously to Patients with Advanced Solid Tumors
Is NCT05076396 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies PM14 for advanced solid tumor.
Treatment: PM14 — Despite recent advances in the treatment of solid tumors in general, advanced (metastatic) disease remains mostly incurable and there is an urgent need to develop new therapeutic options for these patients, particularly investigational drugs with novel mechanisms of action. The investigation of new combination regimens of non-crossresistant agents with acceptable-and not completely overlapping-toxicities has been a major way to improve response rate and outcome of patients with advanced solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: BRCA1 deleterious germline mutation
Required: BRCA2 deleterious germline mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard of care therapy — failed or intolerant
for whom the standard of care therapies have failed, or are intolerant to standard of care therapies that are known to provide clinical benefit
Cannot have received: trabectedin
Prior treatment with trabectedin...within six months prior to onset of study treatment
Cannot have received: Lurbinectedin (PM01183)
Prior treatment with...Lurbinectedin (PM01183) within six months prior to onset of study treatment
Cannot have received: bone marrow or stem cell transplantation
Prior bone marrow or stem cell transplantation
Cannot have received: radiation therapy
Exception: more than 35% of bone marrow
radiation therapy in more than 35% of bone marrow
Lab requirements
Blood counts
ANC ≥1.5 x 10^9/L, platelet count ≥100 x 10^9/L, hemoglobin ≥9 g/dL (patients may be transfused for anemia as clinically indicated prior to study entry)
Kidney function
Creatinine clearance ≥30 mL/min (Cockcroft and Gault's formula)
Liver function
AST and ALT ≤3.0 x ULN; total bilirubin ≤ULN (up to 1.5 x ULN for patients with Gilbert's syndrome)
Cardiac function
QTcF <450 msec, no uncontrolled hypertension (≥160/100 mmHg), no clinically relevant valvular disease, no history of long QT syndrome, no recent ischemic heart disease (≤6 months), no heart failure or LVEF below normal, no significant arrhythmia, no bradycardia (<50 bpm), no use of pacemaker, no ECG abnormalities as listed
Laboratory values within seven days prior to first infusion: ANC ≥1.5 x 10^9/L, platelet count ≥100 x 10^9/L and hemoglobin ≥9 g/dL...AST and ALT ≤3.0 x ULN...Total bilirubin ≤ULN (up to 1.5 x ULN for patients with Gilbert's syndrome)...Creatinine clearance ≥30 mL/min...Serum albumin ≥3 g/dL. Cardiac risk: see exclusion criteria.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Massachusetts General Hospital · Boston, Massachusetts
- MD Anderson Cancer Center · Houston, Texas
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