Actively Recruiting
PM534 Administered Intravenously to Patients With Advanced Solid Tumors
Led by PharmaMar · Updated on 2025-08-22
30
Participants Needed
3
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goals of this trial are to identify the dose limiting toxicities, to determine the maximum tolerated dose and the recommended dose of PM534 in patients with advanced solid tumors. All Patients will receive PM534 via intravenous.
CONDITIONS
Official Title
PM534 Administered Intravenously to Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed and dated written informed consent before any study procedure
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Pathologically confirmed advanced solid tumors
- No more than three prior lines of chemotherapy
- Presence of measurable or non-measurable disease according to RECIST v.1.1
- Recovery to grade 1 or less from previous drug-related adverse events, except grade 2 alopecia
- Laboratory values within seven days before first infusion: ANC ≥1.5 x 10⁹/L, platelets ≥100 x 10⁹/L, hemoglobin ≥9 g/dL
- AST and ALT ≤3 times the upper limit of normal (ULN)
- Total bilirubin ≤ULN (up to 1.5 x ULN for Gilbert's syndrome patients)
- Creatinine clearance ≥30 mL/min or serum creatinine ≤1.5 x ULN
- Serum albumin ≥3 g/dL
- Serum potassium ≥3.5 mmol/L
- Serum magnesium ≥1.6 mg/dL
- Washout periods: at least 3 weeks since last chemotherapy, 4 weeks since last monoclonal antibody therapy, 2 weeks since last biological/investigational therapy or palliative radiotherapy
- For hormone-sensitive breast cancer progressing on hormone therapy (except certain exceptions), stop all other hormonal therapies at least 1 week before study start
- Castrate-resistant prostate cancer patients may continue hormone therapy
- Life expectancy of at least 3 months
You will not qualify if you...
- History or presence of increased cardiac risk including long QT syndrome, QTcF ≥450 msec, ischemic heart disease, heart failure or left ventricular dysfunction (LVEF ≤50%), significant ECG abnormalities, symptomatic arrhythmia, or use of a cardiac pacemaker
- History or current peripheral vascular or cerebrovascular disease
- Any grade of peripheral neuropathy at entry or prior grade 2 or higher peripheral neuropathy from chemotherapy or investigational agents
- Clinical or radiological signs of bowel obstruction
- Active infection requiring systemic treatment
- Known HIV, hepatitis C, or active hepatitis B infection
- Any other major illness increasing risk for study participation as judged by investigator
- Symptomatic, steroid-requiring central nervous system disease
- Carcinomatous meningitis
- Prior bone marrow or stem cell transplantation
- Current treatment with colchicine
- Use of strong or moderate CYP3A4 inhibitors or strong inducers within 2 weeks before first infusion
- Known allergy to any components of PM534
- Inability to comply with treatment or study procedures
- Pregnant or breastfeeding women and fertile patients not using effective contraception
- Pulmonary lymphangitis
- Use of medications with risk of torsades de pointes within five half-lives before first infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
HM Nou Delfos
Barcelona, Spain, 08023
Actively Recruiting
2
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
3
Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
Research Team
G
Gaston Federico Boggio, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here