Patients With Advanced Solid TumorsPhase 1NCT05835609
PM534 Administered Intravenously to Patients With Advanced Solid Tumors
A Phase 1 study testing PM534 in people with Patients With Advanced Solid Tumors, run by PharmaMar at 3 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Advanced Solid Tumors
- What is being tested?
- PM534
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesSpain
- Study dates
- 23 Dec 2022to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed and dated written informed consent, obtained prior to any specific study procedure.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
- Patients must have:
- 3.1 Pathologically confirmed diagnosis of advanced solid tumors 3.2 No more than three prior chemotherapy lines.
- Patients with measurable or non-measurable disease according to the RECIST v.1.1.
- Recovery to grade ≤1 from drug-related adverse events (AEs) of previous disease treatments, excluding grade 2 alopecia.
Show all 21Show fewer
- Laboratory values within seven days prior to first infusion:
- Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L, platelet count ≥100 x 10⁹/L and hemoglobin ≥9 g/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN).
- Total bilirubin ≤ULN (up to 1.5 x ULN for patients with Gilbert's syndrome).
- 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.
- Wash-out periods:
- At least three weeks since the last chemotherapy.
- At least four weeks since the last monoclonal antibody (MAb)-containing therapy.
- At least two weeks since the last biological/investigational single-agent therapy (excluding MAbs) and/or palliative radiotherapy (RT).
- In patients with hormone-sensitive breast cancer progressing while on hormone therapy (except for luteinizing hormone-releasing hormone [LHRH] analogues in pre-menopausal women or megestrol acetate), all other hormonal therapies must be stopped at least one week before study treatment start.
- Castrate-resistant prostate cancer (CRPC) patients may continue receiving hormone therapy prior to and during study treatment.
- Life expectancy ≥3 months
Who cannot join
- Concomitant diseases/conditions:
- Increased cardiac risk:
- History of long QT syndrome.
- Corrected QT interval (QTcF, Fridericia correction) ≥450 msec on screening electrocardiogram (ECG).
- History of or current ischemic heart disease, including myocardial infarction, stable/unstable angina, coronary arteriography or cardiac stress testing with findings consistent with coronary occlusion or infarction or symptomatic arrhythmia.
- History of heart failure or left ventricular dysfunction (left ventricular ejection fraction [LVEF] ≤50%) by multiple-gated acquisition scan (MUGA) or echocardiography (ECHO).
Show all 27Show fewer
- Clinically significant ECG abnormalities, including any of the following: right bundle branch block with left anterior hemiblock, second (Mobitz II) or third degree atrioventricular block and findings suggestive of ischemic heart disease.
- Symptomatic arrhythmia.
- Use of a cardiac pacemaker.
- History of or current peripheral vascular disease or cerebrovascular disease.
- Presence of:
- Any grade of peripheral neuropathy (any etiology) at study entry.
- Prior history of grade ≥ 2 peripheral neuropathy due to any chemotherapeutic or investigational agent.
- Clinical or radiological signs of subocclusion/bowel obstruction.
- Active infection requiring systemic treatment.
- Known human immunodeficiency virus (HIV) or known hepatitis C virus (HCV) infection or active hepatitis B.
- Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study
- Symptomatic, steroid-requiring, central nervous system (CNS) disease.
- Patients with carcinomatous meningitis.
- Prior bone marrow or stem cell transplantation.
- Current treatment with colchicine.
- Use of (strong or moderate) inhibitors or strong inducers of CYP3A4 activity within two weeks prior to the first infusion of PM534
- Known hypersensitivity to any of the components of the drug product.
- Limitation of the patient's ability to comply with the treatment or to follow the protocol procedures.
- Women who are pregnant or breast feeding and fertile patients (men and women) who are not using an effective method of contraception
- Patients with pulmonary lymphangitis.
- Use of medications with known risk of inducing torsades de pointes (TdP) within five half-lives prior to the first infusion of PM534
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
HM Nou Delfos
Barcelona, 08023
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
- Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
About this study
Official title: Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM534 Administered Intravenously to Patients With Advanced Solid Tumors
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.
Read the detailed description
This is a prospective, open-label, dose-escalating phase I study in patients with advanced solid tumors. Patients will be included in cohorts of a minimum of three or six patients to receive PM534 at successively increasing dose levels.
- Conditions
- Patients With Advanced Solid Tumors
- Being tested
- PM534
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM534Drug
PM534 drug product is provided as a powder for concentrate for solution for infusion, is a sterile, preservative-free, lyophilized white cake in a single-dose vial for reconstitution prior to intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| PM534 | Experimental | Patients will be included in cohorts of a minimum of three or six patients to receive PM534 at successively increasing dose levels. Receives: Drug: PM534 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the Maximum Tolerated Dose and the Recommended Dose
A fully evaluable patient is a patient evaluable for the primary objective (i.e., determination of the MTD and the RD).
Measured: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Secondary outcomes (18)
Safety AEs of PM534
AEs will be graded according to the NCI-CTCAE v.5.
Measured: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Safety Hb of PM534
Parameters Labs will be graded according to the NCI-CTCAE v.5.
Measured: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Safety neutrophils of PM534
Parameters Labs will be graded according to the NCI-CTCAE v.5.
Measured: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Safety platelets of PM534
Parameters Labs will be graded according to the NCI-CTCAE v.5.
Measured: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Safety BT of PM534
Parameters Labs will be graded according to the NCI-CTCAE v.5.
Measured: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Safety ALT/AST of PM534
Parameters Labs will be graded according to the NCI-CTCAE v.5.
Measured: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Safety ALK of PM534
Parameters Labs will be graded according to the NCI-CTCAE v.5.
Measured: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Safety creatinine of PM534
Parameters Labs will be graded according to the NCI-CTCAE v.5.
Measured: From the date of first infusion of PM534 to the date of study termination, up to 46 months
QT Assessment
The direct relationship between PM534 plasma concentration C and the change from baseline in QT corrected according to Fridericia's formula (ΔQTcF) will be assessed using linear mixed effects (LME) models.
Measured: During Day of Cycle 1 (each cycle lasts 21 days)
Pharmacokinetics Cmax of PM534
Maximum Plasma Concentration (Cmax). Pharmacokinetic analyses will be evaluated in plasma and urine by standard noncompartmental analysis. Compartmental modeling may be performed if appropriate.
Measured: Cycle 1 from all patients, and also in Cycle 2 from treated patients once the MTD has been determined(each cycle is 21 days).
Pharmacokinetics AUC of PM534
Area Under The Concentration-time Curve (AUC). Pharmacokinetic analyses will be evaluated in plasma and urine by standard noncompartmental analysis. Compartmental modeling may be performed if appropriate.
Measured: Cycle 1 from all patients, and also in Cycle 2 from treated patients once the MTD has been determined(each cycle is 21 days).
Pharmacogenomics Plasma AUC(0-t) of PM534
To analyze the expression levels of Plasma AUC(0-t) of response and/or resistance to treatment with PM534
Measured: Cycle 1 from all patients, and also in Cycle 2 from patients treated once the MTD has been determined) (each cycle is 21 days)
Pharmacogenomics Plasma Cmax of PM534
To analyze the expression levels of Plasma Cmax of response and/or resistance to treatment with PM534
Measured: Cycle 1 from all patients, and also in Cycle 2 from patients treated once the MTD has been determined) (each cycle is 21 days)
Pharmacogenomics Plasma half life of PM534
To analyze the expression levels of Plasma half life of response and/or resistance to treatment with PM534
Measured: Cycle 1 from all patients, and also in Cycle 2 from patients treated once the MTD has been determined) (each cycle is 21 days)
Pharmacogenomics Total body plasma clearance of PM534
To analyze the expression levels of Total body plasma clearance of response and/or resistance to treatment with PM534
Measured: Cycle 1 from all patients, and also in Cycle 2 from patients treated once the MTD has been determined) (each cycle is 21 days)
Pharmacogenomics Volume of distribution of PM534
To analyze the expression levels of Volume of distribution of response and/or resistance to treatment with PM534
Measured: Cycle 1 from all patients, and also in Cycle 2 from patients treated once the MTD has been determined) (each cycle is 21 days)
Pharmacogenomics Percentage of dose recovered in urine of PM534
To analyze the expression levels of Percentage of dose recovered in urine of response and/or resistance to treatment with PM534
Measured: Cycle 1 from all patients, and also in Cycle 2 from patients treated once the MTD has been determined) (each cycle is 21 days)
Efficacy of PM534
To analyze the response rates will be determined in patients with measurable or evaluable disease specific tumor types, time-to-event parameter will also be analyzed ORR.
Measured: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start23 Dec 2022
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Sequential Assignment
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835609
- Sponsor's protocol ID
- PM534-A-001-22
- Status last verified
- Aug 2025
- First submitted
- 7 Feb 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM534 Administered Intravenously to Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05835609
- Acronym / sponsor ID
- PM534-A-001-22
- Conditions
- Patients With Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, open-label, dose-escalating phase I study in patients with advanced solid tumors. Patients will be included in cohorts of a minimum of three or six patients to receive PM534 at successively increasing dose levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential Assignment
| Arm | Type | Receives |
|---|---|---|
| PM534 | Experimental | Drug: PM534Patients will be included in cohorts of a minimum of three or six patients to receive PM534 at successively increasing dose levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Voluntarily signed and dated written informed consent, obtained prior to any specific study procedure.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
- Patients must have:
- 3.1 Pathologically confirmed diagnosis of advanced solid tumors 3.2 No more than three prior chemotherapy lines.
- Patients with measurable or non-measurable disease according to the RECIST v.1.1.
Key exclusion criteria (27 listed)
- Concomitant diseases/conditions:
- Symptomatic, steroid-requiring, central nervous system (CNS) disease.
- Patients with carcinomatous meningitis.
- Prior bone marrow or stem cell transplantation.
- Current treatment with colchicine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PM534PM534 drug product is provided as a powder for concentrate for solution for infusion, is a sterile, preservative-free, lyophilized white cake in a single-dose vial for reconstitution prior to intravenous infusion. | Drug | PM534 |
Primary outcome
Determination of the Maximum Tolerated Dose and the Recommended Dose
Time frame: From the date of first infusion of PM534 to the date of study termination, up to 46 months
A fully evaluable patient is a patient evaluable for the primary objective (i.e., determination of the MTD and the RD).
18 secondary outcomes
Safety AEs of PM534
Time frame: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Safety Hb of PM534
Time frame: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Safety neutrophils of PM534
Time frame: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Safety platelets of PM534
Time frame: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Safety BT of PM534
Time frame: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Safety ALT/AST of PM534
Time frame: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Safety ALK of PM534
Time frame: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Safety creatinine of PM534
Time frame: From the date of first infusion of PM534 to the date of study termination, up to 46 months
QT Assessment
Time frame: During Day of Cycle 1 (each cycle lasts 21 days)
Pharmacokinetics Cmax of PM534
Time frame: Cycle 1 from all patients, and also in Cycle 2 from treated patients once the MTD has been determined(each cycle is 21 days).
Pharmacokinetics AUC of PM534
Time frame: Cycle 1 from all patients, and also in Cycle 2 from treated patients once the MTD has been determined(each cycle is 21 days).
Pharmacogenomics Plasma AUC(0-t) of PM534
Time frame: Cycle 1 from all patients, and also in Cycle 2 from patients treated once the MTD has been determined) (each cycle is 21 days)
Pharmacogenomics Plasma Cmax of PM534
Time frame: Cycle 1 from all patients, and also in Cycle 2 from patients treated once the MTD has been determined) (each cycle is 21 days)
Pharmacogenomics Plasma half life of PM534
Time frame: Cycle 1 from all patients, and also in Cycle 2 from patients treated once the MTD has been determined) (each cycle is 21 days)
Pharmacogenomics Total body plasma clearance of PM534
Time frame: Cycle 1 from all patients, and also in Cycle 2 from patients treated once the MTD has been determined) (each cycle is 21 days)
Pharmacogenomics Volume of distribution of PM534
Time frame: Cycle 1 from all patients, and also in Cycle 2 from patients treated once the MTD has been determined) (each cycle is 21 days)
Pharmacogenomics Percentage of dose recovered in urine of PM534
Time frame: Cycle 1 from all patients, and also in Cycle 2 from patients treated once the MTD has been determined) (each cycle is 21 days)
Efficacy of PM534
Time frame: From the date of first infusion of PM534 to the date of study termination, up to 46 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Related trials for Patients With Advanced Solid Tumors
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of BI 3810944 in Patients With Advanced Cancer
Solid Tumours, Melanoma
RecruitingPhase 1
PAS-004 in Patients With Advanced Solid Tumors
RAS Mutation, NF1 Mutation
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1/2
An Open-label, First-in-Human, Dose-Escalation and Dose-Expansion Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPR1020 in Patients With Advanced Solid Tumors
Advanced Solid Tumors, PARP Inhibitor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PM534 in people with Patients With Advanced Solid Tumors, run by PharmaMar at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaston Federico Boggio, M.D. (+34 91 823 4524, gfboggio@pharmamar.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the Maximum Tolerated Dose and the Recommended Dose (time frame: From the date of first infusion of PM534 to the date of study termination, up to 46 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.