Advanced Solid TumorPhase 1NCT05841563
Clinical Trial of PM54 in Advanced Solid Tumors Patients.
A Phase 1 study testing PM54 in people with Advanced Solid Tumor, run by PharmaMar at 3 sites in 3 countries.
Trial summary
The first part of the study (phase Ia - dose escalation) will evaluate the safety and tolerability and identify the dose-limiting toxicities (DLTs) of PM54. The second part of the study (phase Ib - safety run-in and expansion) will be to reassess the maximum tolerated dose (MTD) defined in the Phase Ia stage in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- PM54
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 28 Apr 2023to 30 Apr 2027
- 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.
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
- Phase Ia (dose escalation) stage: patients must have:
- Pathologically confirmed diagnosis of advanced solid tumors for whom no standard therapy exists:
- Genitourinary tract tumors: urothelial carcinoma, clear cell renal carcinoma and prostate adenocarcinoma.
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- Cutaneous melanoma.
- Gastrointestinal: esophageal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, and poorly differentiated (grade 3) gastroenteropancreatic Neuroendocrine Carcinoma (NEC )with Ki67 index >55%.
- Lung: non-small cell lung cancer (NSCLC) and Small Cell Lung Cancer (SCLC).
- Gynecological tumors: epithelial ovarian carcinoma (including primary peritoneal disease and/or fallopian tube carcinomas), endometrial adenocarcinoma and carcinoma of cervix.
- Breast: ductal or lobular.
- Sarcoma: liposarcoma, leiomyosarcoma, synovial sarcoma and Ewing sarcoma.
- Deleterious germline BRCA1/2 mutation tumors.
- Other: MPM, extrapulmonary small cell carcinoma, adrenocortical carcinoma.
- Note: patients with measurable or non-measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1 (or mRECIST v.1.1 in case of MPM) are eligible during this stage.
- No more than three prior lines of chemotherapy.
- Phase Ib (safety run-in and expansion) stage: patients must have:
- Pathologically confirmed diagnosis of one of the following:
- Extrapulmonary small cell carcinoma) or poorly differentiated grade 3 gastroenteropancreatic NEC with Ki67 index ≥55%.
- Cutaneous melanoma.
- Malignant pleural mesothelioma (MPM).
- Endometrial adenocarcinoma (Note: carcinosarcomas are not allowed).
- Synovial sarcoma
- Measurable disease according to the RECIST v.1.1 (or mRECIST v.1.1 in case of MPM) and/or evaluable disease byserum markers in case of prostate and ovarian cancer (according to the Prostate-Specific Antigen Working Group Recommendations (PSAWGR) and the Gynecologic Cancer Intergroup (GCIG) specific criteria, respectively).
- Progressive disease after last therapy at study entry.
- Patients must have received standard treatments:
- Extrapulomnary small cell carcinoma/ gastroenteropancreatic NEC: no more than two prior lines of chemotherapy.
- Cutaneous melanoma:
- BRAF wild-type (WT) melanoma: at least one prior line of immunotherapy for advanced disease. The patient may have received this therapy in the adjuvant setting. No more than two prior lines of systemic therapy for advanced disease. Note: patients with disease progression during adjuvant therapy or within the first six months after the last dose of adjuvant therapy will be considered as having been treated with one prior line of treatment.
- BRAF-mutated melanoma: at least one prior line of target therapy for advanced disease with BRAF inhibitor with or without MEK-inhibitor, and at least one prior line of immunotherapy for advanced disease. The patient may have received any of these therapies in the adjuvant setting. No more than three prior lines of systemic therapy for advanced disease.
- Malignant pleural mesothelioma (MPM): no more than two prior lines of therapy; one of them should be a platinum containing line. Patients with non-epithelioid MPM should have received a prior immunotherapy line.
- Endometrial adenocarcinoma: no more than two prior lines of chemotherapy for metastatic disease. In addition, regardless of setting, patients must have received one prior platinum-containing regimen.
- Synovial sarcoma: at least one but no more than two prior lines of chemotherapy.
- Recovery to grade ≤1 from drug-related AEs of previous treatments, excluding grade 2 alopecia, according to the NCI-CTCAE v.5.
- Laboratory values within seven days prior to first infusion:
- Absolute Neutrophil Count (ANC) ≥1.5 x 10^9/L, platelet count ≥100 x 10^9/L and hemoglobin ≥9 g/dL (patients may be transfused for anemia as clinically indicated prior to study entry).
- Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤3.0 x ULN.
- Total bilirubin ≤upper limit of normal (ULN) (up to 1.5 x ULN for patients with Gilbert's syndrome).
- Creatinine clearance ≥30 mL/min (calculated using the Cockcroft and Gault's formula).
- Serum albumin ≥3 g/dL. *
- Creatine phosphokinase (CPK) ≤ 2.5 x ULN.
- Washout 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. Note: washout periods will be referred to the day of first cycle administration (Day 1), not to the day of registration.
- Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure during the course of the trial and up to seven months after the last study drug infusion. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last study drug infusion.
- Albumin infusion to increase the blood level in order to fulfill the inclusion criterion is strictly forbidden.
Who cannot join
- For both stages:
- Concomitant diseases/conditions:
- Increased cardiac risk:
- Uncontrolled arterial hypertension despite optimal management (≥160/100 mmHg).
- Presence of clinically relevant valvular disease.
- History of long QT syndrome.
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- Corrected QT interval (QTcF, Fridericia correction) ≥450 ms on screening ECG.
- History of ischemic heart disease, including myocardial infarction, unstable angina, coronary arteriography or cardiac stress testing with findings consistent with coronary occlusion or infarction ≤6 months prior to study entry.
- History of heart failure or left ventricular dysfunction (left ventricular ejection fraction [LVEF] ≤50%) by multiple-gated acquisition scan (MUGA) or echocardiography (ECHO).
- Clinically relevant ECG abnormalities, including any of the following: right bundle branch block with left anterior hemiblock, second (Mobitz II) or third degree atrioventricular block.
- Symptomatic arrhythmia.
- Concomitant medication with risk of inducing torsades de pointes, which cannot be discontinued or switched to an alternative drug prior to start PM54 dosing.
- Use of a cardiac pacemaker.
- Active infection requiring systemic treatment.
- Known human immunodeficiency virus (HIV) or known chronic active hepatitis. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR.
- Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study (e.g., COVID-19).
- Symptomatic, steroid-requiring, and progressing central nervous system (CNS) disease. Exceptions will be made for patients who have completed radiotherapy at least four weeks prior to inclusion (asymptomatic patients taking steroids in the process of already being tapered within two weeks prior to inclusion).
- Patients with carcinomatous meningitis.
- Prior bone marrow or stem cell transplantation.
- Prior treatment with trabectedin, lurbinectedin, or ecubectedin (PM14).
- Use of (strong or moderate) inhibitors or strong inducers of CYP3A4 activity within two weeks prior to the first infusion of PM54.
- 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 a highly effective method of contraception (see inclusion criterion No. 9).
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
United States1 site, 1 recruiting
- Recruiting
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229-3307
Kyriakos P Papadopoulos
Belgium1 site, 1 recruiting
- Recruiting
Institut Jules Bordet
Anderlecht, 1070
Nuria Kotecki
Spain1 site, 1 recruiting
- Recruiting
HM Universitario Sanchinarro
Madrid, M, 28050
Maria-Jose de Miguel-Luken
About this study
Official title: Phase I/Ib, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM54 Administered Intravenously to Patients With Selected Advanced Solid Tumors.
The first part of the study (phase Ia - dose escalation) will evaluate the safety and tolerability and identify the dose-limiting toxicities (DLTs) of PM54.
The second part of the study (phase Ib - safety run-in and expansion) will be to reassess the maximum tolerated dose (MTD) defined in the Phase Ia stage in a framework of more extensive premedication, and to evaluate the antitumor activity of PM54 according to the RECIST v.1.1 (or mRECIST v.1.1 in case of MPM) and/or serum markers as appropriate, in patients with selected advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- PM54
- Keywords
- Advanced Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM54Drug
PM54 powder for concentrate for solution for infusion (3 mg/vial) is a sterile, preservative-free, lyophilized white to yellowish cake in a single-dose vial for reconstitution prior to intravenous infusion. Each vial contains 3 mg PM54.
Route of administration: Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| PM54 | Experimental | Phase Ia (dose escalation) stage: Patients will receive PM54 i.v. at a starting dose of 0.3 mg/m2.
Phase Ib (safety run-in) stage: The maximum tolerated dose (MTD) of PM54 previously defined in Phase Ia will be reassessed.
Phase Ib (expansion) stage: Patients will receive PM54 i.v. at the recommended dose selected after the safety run-in stage. Receives: Drug: PM54 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a (dose escalation) and Phase1b (safety run-in): Dose-limiting toxicities (DLTs)
Measured: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Drug-related Adverse Events (AEs)
Measured: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Drug-related deaths
Measured: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Serious adverse events (SAEs)
Measured: Screening up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Drug-related delays
Measured: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Dose reductions
Measured: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Treatment discontinuations
Measured: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Maximum tolerated dose (MTD)
Lowest dose level explored during dose escalation in which one third (i.e., 33%) or more of evaluable patients develop a DLT in Cycle 1.
Measured: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Recommended dose (RD)
Once the maximum tolerated dose (MTD) is reached, lower dose level will be confirmed as the RD if less than one third (i.e., 33%) of at least nine fully evaluable patients at that dose level develop DLT during Cycle 1.
Measured: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase1b (safety run-in): Determination of RD with more extensive premedication
A dose level will be confirmed as the RD with more extensive premedication if less than one third (i.e., 33%) of at least nine fully evaluable patients at that dose level develop DLT during Cycle 1.
Measured: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1b (expansion): Antitumor activity
Antitumor activity, evaluated according to the RECIST v.1.1 (or mRECIST v.1.1 in case of MPM) and serum markers, as appropriate.
Measured: Every 6 weeks (± 1 week) in all patients with evaluable disease until Cycle 6. For patients continuing treatment after Cycle 6, assessments performed every 9 weeks (± 1 week) while on treatment, unless otherwise indicated (Up to 48 months)
Secondary outcomes (13)
Phase 1b (expansion): Adverse events (AEs)
AEs will be graded according to the NCI-CTCAE v.5.
Measured: Screening to end of study (up to approximately 48 months)
Phase 1b (expansion): Treatment discontinuation
Measured: Day 1 up to end of study (up to approximately 48 months)
Phase 1b (expansion): Dose reductions
Measured: Day 1 up to end of study (up to approximately 48 months)
Phase 1b (expansion): Treatment delays due to adverse events (AEs)
Measured: Day 1 up to end of study (up to approximately 48 months)
Phase 1a (dose escalation) and Phase 1b (safety run-in): QT Assessment
The QT assessment will evaluate the risk of prolongation of the QT interval by PM54.
Measured: Day 1 of Cycle 1 for all patients participating in the QT assessment, and on Day 1 of Cycle 2 for patients treated during the Phase Ia stage once the MTD has been determined, will be used in this substudy.
Phase 1a (dose escalation) and Phase 1b (safety run-in): Maximum Plasma Concentration (Cmax)
Measured: Cycle 1 and Cycle 2 during the Phase Ia (dose expansion) stage once the MTD has been determined. Each cycle is 21 days.
Phase 1a (dose escalation) and Phase 1b (safety run-in): Concentration in urine samples
Measured: Day 1 of Cycle 1 and Cycle 2 during the Phase Ia (dose expansion) stage once the MTD has been determined. Each Cycle is 21 days.
Phase 1b (safety run-in and dose expansion): Percentage of patients with clinical benefit (overall response rate (ORR) or stable disease (SD) ≥4 months associated with tumor shrinkage)
Measured: Day 1 up to end of study (up to approximately 48 months)
Phase 1b (safety run-in and dose expansion): Response rate
Response rate defined as percentage of patients with partial response (PR), with complete response (CR), or the sum of both [overall response rate (ORR)].
Measured: Day 1 up to end of study (up to approximately 48 months)
Phase 1b (safety run-in and dose expansion): Percentage of patients with stable disease (SD) ≥4 months
Measured: Day 1 up to end of study (up to approximately 48 months)
Phase 1b (safety run-in and dose expansion): Duration of Response (DoR)
Measured: From the date of the first documentation of response to the date of documented progression or death, assessed up to 48 months
Phase 1b (safety run-in and dose expansion): Progression-free Survival (PFS)
Measured: From the date of first infusion of study treatment to the date of first documented progression or date of death from any cause, assessed up to 48 months
Phase 1b (safety run-in and dose expansion): Overall survival (OS)
Measured: From the date of first infusion of study treatment to the date of death (due to any cause) or last contact (in this case, survival will be censored on the date of last contact), assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start28 Apr 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841563
- Sponsor's protocol ID
- PM54-A-001-22
- Other IDs
- 2023-508644-22-00, 2023
- Status last verified
- Sep 2025
- First submitted
- 31 Mar 2023
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/Ib, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM54 Administered Intravenously to Patients With Selected Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT05841563
- Acronym / sponsor ID
- PM54-A-001-22
- Conditions
- Advanced Solid Tumor
- Keywords
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 3 May 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 first part of the study (phase Ia - dose escalation) will evaluate the safety and tolerability and identify the dose-limiting toxicities (DLTs) of PM54.
The second part of the study (phase Ib - safety run-in and expansion) will be to reassess the maximum tolerated dose (MTD) defined in the Phase Ia stage in a framework of more extensive premedication, and to evaluate the antitumor activity of PM54 according to the RECIST v.1.1 (or mRECIST v.1.1 in case of MPM) and/or serum markers as appropriate, in patients with selected advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PM54 | Experimental | Drug: PM54Phase Ia (dose escalation) stage: Patients will receive PM54 i.v. at a starting dose of 0.3 mg/m2. Phase Ib (safety run-in) stage: The maximum tolerated dose (MTD) of PM54 previously defined in Phase Ia will be reassessed. Phase Ib (expansion) stage: Patients will receive PM54 i.v. at the recommended dose selected after the safety run-in stage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (49 listed)
- Voluntarily signed and dated written informed consent, obtained prior to any specific study procedure.
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
- Phase Ia (dose escalation) stage: patients must have:
- Note: patients with measurable or non-measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1 (or mRECIST v.1.1 in case of MPM) are eligible during this stage.
Key exclusion criteria (24 listed)
- Concomitant diseases/conditions:
- Symptomatic, steroid-requiring, and progressing central nervous system (CNS) disease. Exceptions will be made for patients who have completed radiotherapy at least four weeks prior to inclusion (asymptomatic patients taking steroids in the process of already being tapered within two weeks prior to inclusion).
- Patients with carcinomatous meningitis.
- Prior bone marrow or stem cell transplantation.
- Prior treatment with trabectedin, lurbinectedin, or ecubectedin (PM14).
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 |
|---|---|---|
| PM54PM54 powder for concentrate for solution for infusion (3 mg/vial) is a sterile, preservative-free, lyophilized white to yellowish cake in a single-dose vial for reconstitution prior to intravenous infusion. Each vial contains 3 mg PM54. Route of administration: Intravenous infusion | Drug | PM54 |
Primary outcome
Phase 1a (dose escalation) and Phase1b (safety run-in): Dose-limiting toxicities (DLTs)
Time frame: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Drug-related Adverse Events (AEs)
Time frame: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Drug-related deaths
Time frame: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Serious adverse events (SAEs)
Time frame: Screening up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Drug-related delays
Time frame: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Dose reductions
Time frame: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Treatment discontinuations
Time frame: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Phase 1a (dose escalation) and Phase1b (safety run-in): Maximum tolerated dose (MTD)
Time frame: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Lowest dose level explored during dose escalation in which one third (i.e., 33%) or more of evaluable patients develop a DLT in Cycle 1.
Phase 1a (dose escalation) and Phase1b (safety run-in): Recommended dose (RD)
Time frame: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
Once the maximum tolerated dose (MTD) is reached, lower dose level will be confirmed as the RD if less than one third (i.e., 33%) of at least nine fully evaluable patients at that dose level develop DLT during Cycle 1.
Phase1b (safety run-in): Determination of RD with more extensive premedication
Time frame: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)
A dose level will be confirmed as the RD with more extensive premedication if less than one third (i.e., 33%) of at least nine fully evaluable patients at that dose level develop DLT during Cycle 1.
Phase 1b (expansion): Antitumor activity
Time frame: Every 6 weeks (± 1 week) in all patients with evaluable disease until Cycle 6. For patients continuing treatment after Cycle 6, assessments performed every 9 weeks (± 1 week) while on treatment, unless otherwise indicated (Up to 48 months)
Antitumor activity, evaluated according to the RECIST v.1.1 (or mRECIST v.1.1 in case of MPM) and serum markers, as appropriate.
13 secondary outcomes
Phase 1b (expansion): Adverse events (AEs)
Time frame: Screening to end of study (up to approximately 48 months)
Phase 1b (expansion): Treatment discontinuation
Time frame: Day 1 up to end of study (up to approximately 48 months)
Phase 1b (expansion): Dose reductions
Time frame: Day 1 up to end of study (up to approximately 48 months)
Phase 1b (expansion): Treatment delays due to adverse events (AEs)
Time frame: Day 1 up to end of study (up to approximately 48 months)
Phase 1a (dose escalation) and Phase 1b (safety run-in): QT Assessment
Time frame: Day 1 of Cycle 1 for all patients participating in the QT assessment, and on Day 1 of Cycle 2 for patients treated during the Phase Ia stage once the MTD has been determined, will be used in this substudy.
Phase 1a (dose escalation) and Phase 1b (safety run-in): Maximum Plasma Concentration (Cmax)
Time frame: Cycle 1 and Cycle 2 during the Phase Ia (dose expansion) stage once the MTD has been determined. Each cycle is 21 days.
Phase 1a (dose escalation) and Phase 1b (safety run-in): Concentration in urine samples
Time frame: Day 1 of Cycle 1 and Cycle 2 during the Phase Ia (dose expansion) stage once the MTD has been determined. Each Cycle is 21 days.
Phase 1b (safety run-in and dose expansion): Percentage of patients with clinical benefit (overall response rate (ORR) or stable disease (SD) ≥4 months associated with tumor shrinkage)
Time frame: Day 1 up to end of study (up to approximately 48 months)
Phase 1b (safety run-in and dose expansion): Response rate
Time frame: Day 1 up to end of study (up to approximately 48 months)
Phase 1b (safety run-in and dose expansion): Percentage of patients with stable disease (SD) ≥4 months
Time frame: Day 1 up to end of study (up to approximately 48 months)
Phase 1b (safety run-in and dose expansion): Duration of Response (DoR)
Time frame: From the date of the first documentation of response to the date of documented progression or death, assessed up to 48 months
Phase 1b (safety run-in and dose expansion): Progression-free Survival (PFS)
Time frame: From the date of first infusion of study treatment to the date of first documented progression or date of death from any cause, assessed up to 48 months
Phase 1b (safety run-in and dose expansion): Overall survival (OS)
Time frame: From the date of first infusion of study treatment to the date of death (due to any cause) or last contact (in this case, survival will be censored on the date of last contact), assessed up to 48 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 24 Sep 2025.
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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 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PM54 in people with Advanced Solid Tumor, run by PharmaMar at 3 sites in 3 countries.
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 49 inclusion and 24 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 24 Sep 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 United States, Belgium, 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 Cristian M Fernández, M.D. (+ 34 91 846 6077, cmfernandez@pharmamar.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a (dose escalation) and Phase1b (safety run-in): Dose-limiting toxicities (DLTs) (time frame: Day 1 Cycle 1 up to end of first cycle of treatment (Cycle 1 is 21 days)). The study lists 12 primary outcomes in all. 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 24 Sep 2025.