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Advanced Solid TumorPhase 1/2NCT07839819

Study of PM54 in Combination With Cytotoxic and Targeted Agents in Adult Participants With Advanced Malignancies

A Phase 1/2 study testing PM54, Irinotecan and Doxorubicin in people with Advanced Solid Tumor, run by PharmaMar at 9 sites in 4 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The primary purpose of this study is to evaluate the safety, tolerability and recommended dose (RD) of PM54 in combination with cytotoxic and targeted anticancer agents in adult participants with advanced solid tumors. 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, Irinotecan and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
231 participants
Where
9 sitesin 4 countries
Study dates
12 Nov 2026to 27 Nov 2029
Phase
Phase 1/2
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 before the start of any study-specific procedures.
  • Adults greater than or equal to (>=) 18 years and able to provide free and informed consent for study participation.
  • Have a pathologically confirmed diagnosis of 1 of the following (Tumor types have been omitted, as this information is not public.):
  • Sub- study 1
  • Tumor type, previously treated with 1 to 2 prior lines of therapy for advanced disease, which must have included at least 1 line of platinumbased chemotherapy and programmed cell death protein 1 inhibitor if locally available and approved. All histological subtypes are eligible.
  • Tumor type, previously treated with 1 to 3 prior lines of therapy for advanced disease.
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  • Tumor type, previously treated with at least 1 but no more than 2 prior lines of chemotherapy.
  • Sub- study 2
  • Tumor type, with a maximum of 1 prior line of treatment for advanced disease, and tumor type in Part 2, with no prior treatment for advanced disease.
  • Tumor type, with 2 or 3 prior lines of treatment for advanced disease, which must have included platinum-based chemotherapy and a programmed cell death protein-1 inhibitor. These may have been received as part of a single regimen or in separate regimens.
  • Note: For the purpose of counting lines of therapy, regimens given as part of multi-modal treatment for localized tumor type (induction/consolidation) are considered 1 line of therapy if disease relapse has occurred during or up to 6 months following treatment discontinuation.
  • Have an advanced disease, as defined by progressive, relapsed, or metastatic disease that is not amenable to multimodal ablative or excisional treatments with curative intent, according to international guidelines.
  • Have a measurable disease according to RECIST v 1.1. Lesions in areas previously treated with radiation or ablative local therapies must, in addition to measurability requirements defined in RECIST v1.1, only be considered measurable if they experienced documented progression following local treatments.
  • Have experienced objective disease progression on or following the last prior line of systemic therapy, as determined either by RECIST v1.1 or equivalent. This does not apply to first-line indications.
  • Eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1 at screening.
  • Individuals with central nervous system (CNS) metastases are eligible, as long as all of the following are met:
  • Asymptomatic or minimally symptomatic and stable, with no worsening symptoms in the 4 weeks prior to start of study intervention.
  • Does not require systemic corticosteroids in excess of an equivalent prednisone dose of 5 milligrams (mg) per day.
  • Has undergone surgery or radiation and recovered of the effects thereof or are undergoing active surveillance for small-volume CNS metastases with no immediate risk of worsening. A minimum of 2 weeks must have elapsed between the end of radiation treatment and study intervention.
  • Have not had an epileptic seizure within the 4 weeks prior to start of anticancer treatment and are either free of antiepileptics or on a stable dose prescribed as prophylaxis (as long as no interaction is reported with any of the study drugs).
  • Adequate laboratory parameters, as specified below, within 7 days of start of study intervention:
  • Absolute neutrophil count (ANC) >=2*109^9 per Litre (1/L), platelet count >=100*109^9 per liter, and hemoglobin >=9 grams per deciliter (g/dL).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to (<=) 3.0 * the upper limit of normal (ULN).
  • Total bilirubin <=ULN; up to 1.5*ULN for participants with Gilbert's syndrome.
  • Creatinine clearance >=30 milliliters per minute (mL/min), calculated using the cockcroft and gault's formula.
  • Serum albumin >=3 g/dL. Albumin infusion to increase the blood level in order to fulfill this inclusion criterion is strictly forbidden.
  • Sub- study 1
  • Total bilirubin <= upper limit of normal. Participants with Gilbert's syndrome are not allowed.
  • Recovered from the effects of any prior surgery or radiation.
  • No ongoing toxicities from prior anticancer treatment of grade greater than (>) 1 (per national cancer institute common terminology criteria for adverse events [NCI-CTCAE] v6.0), except for alopecia and other Grade 2 toxicities that are considered by the investigator to have stabilized/resolved with sequelae and are not at risk of worsening with study intervention. Residual Grade 1 to 2 toxicities from prior immunotherapy - which may include hypo-or hyperthyroidism, type 1 diabetes, hyperglycemia, and adrenal insufficiency - are allowed, if stable and on a stable dose of replacement therapy as applicable.
  • Is willing to undergo trial procedures as specified in the protocol, including provision of biologic samples, as well as any study requirements.
  • Evidence of nonchildbearing 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 7 months after the last study intervention infusion. Fertile male participants with WOCBP partners should use condoms during treatment and for 4 months following the last study intervention infusion.

Who cannot join

  • To be eligible for trial participation, individuals must not meet any of the following criteria:
  • Prior treatment with PM54 or any other ecteinascidin agent.
  • History of hypersensitivity to PM54 or any of the inactive ingredients.
  • History of other malignancies within 3 years prior to start of study intervention, except adequately resected non-melanoma skin cancer, low-risk and adequately treated prostate cancer, stage I hormone receptor (HR)-positive breast cancer or other in-situ disease at neglectable risk of relapse.
  • Presence of carcinomatous meningitis.
  • Participants with clinically significant ascites, defined as any of the following:
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  • Ascites requiring therapeutic paracentesis or medication (such as diuretics) in the last 4 weeks;
  • Moderate or severe ascites on imaging;
  • Symptomatic ascites (examples: abdominal distension, discomfort, or dyspnea).
  • Presence of any of these medical conditions.
  • Cardiovascular:
  • History of myocardial, CNS, or other arterial infarction within 6 months before the start of study intervention.
  • Heart failure Class II or higher according to the New York Heart Association or left ventricular ejection fraction less than (<) 50 percent (%) per echocardiogram or multigated acquisition scan.
  • Symptomatic arrhythmia or other significant electrocardiogram (ECG) abnormalities that in the opinion of the investigator pose an increased risk of complications.
  • Corrected start of the Q wave to the end of the T wave interval (QTc) >470 milliseconds (ms) on the screening ECG or history of a long QT syndrome.
  • Respiratory
  • Severe underlying lung disorder, as per investigator's assessment that can include but not restricted to chronic obstructive pulmonary disease, asthma, restrictive lung disease, or significant pleural effusions not related to the study condition or unlikely to stabilize/benefit with systemic treatment.
  • New onset or worsening of pulmonary embolism or deep vein thrombosis within the previous 2 months, or any history thereof if no stable dose of anticoagulant regimen has been achieved.
  • Other
  • Uncontrolled infection requiring antimicrobial agents or unexplained fever within 3 days of the first scheduled day of dosing. Participants with tumor fever may be enrolled if infectious etiology has been adequately ruled out.
  • Prior bone marrow or stem cell transplantation.
  • Sub- study 1 i. Evidence of Gilbert's syndrome or homozygosity for the UGT1A128 allele. j. Chronic inflammatory bowel disease or intestinal obstruction.
  • Sub- study 2 k. Patients with Child-Pugh Class C hepatic impairment.
  • Has any other medical, behavioral, or social condition that, in the opinion of the investigator, makes the participant ineligible to receive any of the trial treatments cytochrome P450, or undergo key trial procedures.
  • Exposure to the products/treatments below, without adequate washout period prior to first dose of study intervention. Note that hormonal therapy received for the adjuvant treatment of tumors at a low risk of relapse is allowed.
  • Products/treatments and washout periods:
  • Traditional Chinese or herbal medicine with the intent to treat cancer or with known effects on drug metabolism: 2 weeks.
  • Live, attenuated vaccines: 30 days.
  • Chemotherapy: 21 days.
  • Antibodies and antidrug conjugates: 28 days.
  • Targeted agents and small molecules: 2 weeks or 5 half-lives, whichever is longer.
  • Major surgery: 4 weeks. Note: Surgeries typically performed in an outpatient setting are not considered major, even if light sedation or an inpatient stay for oversight was needed.
  • Whole-brain radiation therapy, stereotactic therapy, palliative radiation for symptom control and minor impact on bone marrow: 2 weeks.
  • Other radiation therapy: 4 weeks.
  • Any medication associated with known risk of torsade de pointes: 5 half-lives, except if considered indicated by the investigator, ideally for short duration, under medical monitoring and if no other risk factors for torsade de pointes are present such as prolonged QTc or significant electrolyte abnormalities.
  • Strong or moderate inhibitors of cytochrome P450 3A (CYP3A): 1 week or 5 half-lives, whichever is longer.
  • Strong inducers CYP3A: 2 weeks or 5 half-lives, whichever is longer.
  • P-glycoprotein (P-gp) inhibitors: 2 weeks except for amiodarone, tamoxifen, isavuconazole, and mifepristone (4 weeks).
  • Sub- study 1
  • Strong inhibitors or inducers of UGT1A1: 1 week
  • Sub- study 2
  • CYP2D6 strong inhibitors (bupropion, fluoxetine, paroxetine, quinidine, terbinafine): 1 week or 5 half-lives, whichever is longer.
  • Active Human Immunodeficiency Virus (HIV) infection. Inclusion is allowed if:
  • Undergoing adequate anti-viral treatment and regular clinical oversight with good compliance.
  • Undetectable HIV viral load.
  • Cluster of differentiation 4 (CD4) plus (+) lymphocyte count over 350/millimeters to the third power (mm3).
  • No evidence or suspicion of opportunistic infection.
  • Antiretroviral medication(s) which is/are not contraindicated. Note: The investigator should obtain and provide the sponsor with written documentation of the above, assessed by a medical doctor experienced in the management of individuals with HIV.
  • Individuals with detectable hepatitis C virus (HCV) ribonucleic acid (RNA), which should be tested in case of positive anti-HCV antibody test.
  • Positive serology test of hepatitis B surface antigen (HBsAg) with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) >=1000 international unit per milliliter (IU/mL). HBV DNA test is mandatory in case of HBsAg+. Individuals with detectable HBV DNA <1000 IU/mL or suspected occult HBV infection must undergo prophylaxis of HBV reactivation in order to be eligible.
  • Individuals with a short-term risk of anatomic complications from involvement of critical structures such as major vessels, large airways, and vertebral spine.
  • Women who are pregnant or breastfeeding and fertile participants (men and women) who are not using a highly effective method of contraception.

Trial locations and contacts

9 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Gaston Federico Boggio, M.D contact

+34 91 823 4524

gfboggio@pharmamar.com

9 sites in 4 countries

France3 sites

  • Institut Bergonie

    Bordeaux

  • Centre Leon Berard - Lyon

    Lyon

  • Centre Antoine Lacassagne

    Nice

Other trials in France

United States2 sites

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

Other trials in United States

Germany2 sites

  • Helios Klinikum Berlin-Buch

    Buckow

  • Universitaetsmedizin Mainz

    Mainz

Other trials in Germany

Portugal2 sites

  • START Lisbon - ULS Santa Maria

    Lisbon

  • Instituto Portugues De Oncologia Do Porto Francisco Gentil Epe Ipo Porto Ipopfg Clinica De Onco Hematologia

    Porto

Other trials in Portugal

About this study

Official title: Phase 1/2 Master Study to Assess the Safety and Efficacy of PM54 in Combination With Cytotoxic and Targeted Agents for the Treatment of Advanced Solid Tumors

The primary purpose of this study is to evaluate the safety, tolerability and recommended dose (RD) of PM54 in combination with cytotoxic and targeted anticancer agents in adult participants with advanced solid tumors. The study will also assess the antitumor activity of PM54 in combination with cytotoxic and targeted anticancer agents in terms of objective response rate (ORR) based on investigator's assessment in participants in other cohorts.

Read the detailed description

The main study will comprise several sub-studies evaluating PM54 in combination with different anticancer agents, starting with the following combinations: PM54 plus irinotecan and PM54 plus doxorubicin.

Each sub-study includes Part 1 (Dose Escalation) and Part 2 (Dose Expansion). In Part 1, participants with advanced malignancies of selected tumor types will receive escalated doses of PM54 in combination with the relevant anticancer agent until a suitable dose is established, or until clinical or objective disease progression, withdrawal of consent, or unacceptable or cumulative toxicity occurs. In Part 2, participants with advanced malignancies will receive the recommended dose combination of PM54 and the relevant combination product identified during Part 1 of the corresponding sub-study.

Being tested
PM54, Irinotecan, Doxorubicin
Keywords
Transcription inhibitor, Deoxyribonucleic acid, Antiproliferative effect, Antineoplastic, Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07839819
Study groupRoleWhat they receive
Part 1 (Dose Escalation) - PM54 + IrinotecanExperimentalParticipants will initially receive a low dose of PM54 in combination with a low dose of Irinotecan (sub- study 1). If the initial dose level is tolerated, the doses of PM54 and Irinotecan may be escalated to higher dose levels according to the study protocol until a suitable dose for the combination is established, or until clinical or objective disease progression, withdrawal of consent, or unacceptable or cumulative toxicity occurs.
Receives: Drug: PM54; Drug: Irinotecan
Part 1 (Dose Expansion) - PM54 + IrinotecanExperimentalParticipants will receive the recommended dose combination of PM54 and Irinotecan as identified in Part 1 of the study (sub- study 1).
Receives: Drug: PM54; Drug: Irinotecan
Part 2 (Dose Escalation) - PM54 + DoxorubicinExperimentalParticipants will initially receive a low dose of PM54 in combination with a low dose of Doxorubicin. If the initial dose level is tolerated, the doses of PM54 and Doxorubicin may be escalated to higher dose levels according to the study protocol until a suitable dose for the combination is established, or until clinical or objective disease progression, withdrawal of consent, or unacceptable or cumulative toxicity occurs.
Receives: Drug: PM54; Drug: Doxorubicin
Part 2 (Dose Expansion - PM54 + DoxorubicinExperimentalParticipants will receive the recommended dose combination of PM54 and Doxorubicin as identified in Part 1 of the study (sub - study 2).
Receives: Drug: PM54; Drug: Doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parts 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Treatment Discontinuation or Dose Modifications

    Measured: Time from the first administration of study intervention until 30 days after study intervention discontinuation or initiation of new subsequent anticancer therapy, whichever occurs first (up to 5 years)

  2. Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs)

    Measured: Cycle 1 (each cycle is of 21 days)

  3. Part 2: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1

    Percentage of participants who achieve a best overall response of complete response (CR) or partial response (PR), as determined by investigator assessment of tumor images according to RECIST v1.1. CR is defined as disappearance of all target lesions and all non-target lesions, with any pathological lymph nodes reduced to <10 mm in short axis, and no new lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline, with no progression of non-target lesions and no new lesions.

    Measured: Baseline up to 5 years

Secondary outcomes (10)

  1. Part 1 and 2: Clinical Benefit Rate (CBR)

    Percentage of participants who achieve either an objective tumor response (CR or PR or stable disease) with an absence of tumor progression during the first 12 weeks, as determined by investigator assessment according to RECIST v1.1. CR is defined as disappearance of all target lesions, with any pathological lymph nodes reduced to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of diameters while on study. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters while on study, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions.

    Measured: Up to 12 weeks

  2. Part 1 and 2: Confirmed ORR

    Percentage of participants who achieve a confirmed objective response (CR or PR), as determined by investigator assessment according to RECIST v1.1. CR is defined as disappearance of all target lesions, with any pathological lymph nodes reduced to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline. A response is considered confirmed when a subsequent assessment performed at least 4 weeks after the initial response confirms CR or PR.

    Measured: Baseline Up to 5 years

  3. Parts 1 and 2: Disease Control Rate (DCR)

    Percentage of participants who achieve a best overall response of stable disease, PR, or CR, as determined by investigator assessment according to RECIST v1.1. CR is defined as disappearance of all target lesions, with any pathological lymph nodes reduced to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.

    Measured: Baseline up to 5 years

  4. Parts 1 and 2: Progression-Free Survival

    Measured: Baseline up to 5 years

  5. Parts 1 and 2: Duration of Response

    Measured: Baseline to 5 years

  6. Parts 1 and 2: Time to Treatment Failure (TTF)

    Measured: Baseline up to 5 years

  7. Parts 1 and 2: Overall Survival (OS)

    Measured: Baseline up to 5 years

  8. Parts 1: Maximum Observed Plasma Concentration (Cmax) of PM54 and the Combination Product

    Measured: Cycle 1, Day 1 (each cycle is of 21 days)

  9. Parts 1: Area Under the Plasma Concentration-Time Curve (AUC) of PM54 and the Combination Product

    Measured: Cycle 1, Day 1 (each cycle is of 21 days)

  10. ORR per RECIST v1.1

    Percentage of participants who achieve a best overall response of CR or PR, as determined by investigator assessment according to RECIST v1.1. CR is defined as disappearance of all target lesions, with any pathological lymph nodes reduced to <10 mm in short axis. PR is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline.

    Measured: Baseline Up to 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2026
  2. Study start12 Nov 2026 (estimated)
  3. Primary completion27 Sep 2029 (estimated)
  4. Study completion27 Nov 2029 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
231 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07839819
Sponsor's protocol ID
PM54-A-004-26
Status last verified
Sep 2026
First submitted
16 Sep 2026
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PM54, Irinotecan and Doxorubicin in people with Advanced Solid Tumor, run by PharmaMar at 9 sites in 4 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 32 inclusion and 52 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: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France, United States, Germany, Portugal. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Parts 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Treatment Discontinuation or Dose Modifications (time frame: Time from the first administration of study intervention until 30 days after study intervention discontinuation or initiation of new subsequent anticancer therapy, whichever occurs first (up to 5 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07839819.

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 2026.

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