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RecruitingNCT05146440PRIMEUpdated Mar 21, 2025

Multicohort Trial of Different Schemes of PM14 in Monotherapy and in Combination with Radiotherapy in Soft Tissue Sarcomas and Other Solid Tumor

A Phase 1/2 interventional study of PM14 in Advanced Soft-tissue Sarcoma, Advanced L-sarcomas and Other Advanced Sarcomas, sponsored by Grupo Espanol de Investigacion en Sarcomas. Recruiting at 4 sites in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by Grupo Espanol de Investigacion en Sarcomas · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Nov 2021; still recruiting 4 years 11 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
195
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Phase Ib/II, multicohort, single arm, open-label, multicenter, international clinical trial, with 6 cohorts (advanced STS, advanced L-sarcomas, other advanced sarcomas, advanced solid tumors, and localized STS) with 4 sites in Spain for phase I.

The aim of this study is to explore different infusions of PM14 (longer or repeated) in order to obtain a potentially better efficacy and similar toxicity profile in advanced soft tissue sarcoma patients as monotherapy and also in other solid tumors as concomitant treatment with radiation therapy.

Treatment

Cohort A

A phase I dose-finding stage for PM14 is planned with an estimated number of 20-25 patients. PM14 will be tested at different dose levels in 24-h IV infusion on day 1 of 21-day cycles, up to progression or unacceptable toxicity. Premedication with dexamethasone is recommended on the day before treatment initiation.

Cohort B

A phase I dose-finding stage for PM14 is planned with an estimated number of 20-25 patients. PM14 will be tested at different dose levels in 3-h IV infusion during 3 consecutive days (days 1-3) of 21-day cycles, up to progression or unacceptable toxicity. Premedication with dexamethasone is recommended on the day before treatment initiation.

Cohort E

PM14 will be administered at the recommended phase II dose (RP2D) according to the most convenient scheme. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation. Cycles will be repeated every 21 days up to progression or unacceptable toxicity.

Cohort F

PM14 will be administered at the RP2D according to the most convenient scheme. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation. Cycles will be repeated every 21 days up to progression or unacceptable toxicity.

Cohort C

Phase I: PM14 will be administered at the RP2D according to the most convenient scheme in 21-day cycles, at at different dose levels in combination with radiotherapy, up to progression or unacceptable toxicity. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation and during 2 additional days (in the 24-hour infusion) and during 3 additional days (in the 3-hour infusion). Radiation therapy will start within 1 hour of PM14 infuser disconnection and will be administered with 3 Gy per fraction for 10 days (30 Gy in total).

Phase II: PM14 will be administered at RP2D concomitant with radiation therapy.

Cohort D

Phase I: PM14 will be administered at the RP2D according to the most convenient scheme, in up to 3 x 21-day cycles in neoadjuvant setting, at different dose levels in combination with radiotherapy. Cycles will be administered by central venous port. Premedication with dexamethasone is recommended on the day before treatment initiation. Radiation therapy will start within 1 hour of PM14 infuser disconnection and will be administered with 1.8 Gy per fraction for 25 days (45 Gy in total).

Phase II: PM14 will be administered at RP2D concomitant with radiation therapy.

Read the detailed description

Cohort A and B (Phase I, PM14 monotherapy, advanced STS): 20-25 patients approximately per cohort.

Cohort E (Phase II, PM14 monotherapy, advanced L-sarcomas): 28 patients; (Simon's two-stage Minimax design), errors: α= 0.05; β=0.80, option related to efficacy = 35% (6-month PFSR) (Sample size 15+13), success in 6-month PFSR of ≤ 15% will be considered as unacceptable (H0), and would not warrant further investigation (null hypothesis). Success in 6-month PFSR of ≥ 35% will be considered as an acceptable result warranting further investigation of the investigational drug (H1, alternative hypothesis). A total of 15 eligible and treated patients will be included in the first stage of the study. If ≤ 2 successes are observed, the trial will be stopped in this cohort with the conclusion that the experimental treatment should not be further investigated. Else (≥ 3 successes), patients will continue to be accrued until 28 eligible patients enter the study. If 8 or more successes are observed in those 28 patients, it will be concluded that the results of this trial warrant further investigation.

Cohort F (Phase II, PM14 monotherapy, other advanced sarcomas): 29 patients; (Simon's two-stage Optimal design), errors: α= 0.05; β=0.80. option related to efficacy = 30% (6-month PFSR) (Sample size 10+19), success in 6-month PFSR of ≤ 10% will be considered as unacceptable (H0), and would not warrant further investigation (null hypothesis). Success in 6-month PFSR of ≥ 30% will be considered as an acceptable result warranting further investigation of the investigational drug (H1, alternative hypothesis). A total of 10 eligible and treated patients will be included in the first stage of the study. If ≤ 1 successes are observed, the trial will be stopped in this cohort with the conclusion that the experimental treatment should not be further investigated. Else (≥ 2 successes), patients will continue to be accrued until 29 eligible patients enter the study. If 6 or more successes are observed in those 29 patients, it will be concluded that the results of this trial warrant further investigation.

Cohort C (Best scheme of PM14 plus RTP in advanced sarcoma, head \& neck, other solid tumors)

Phase I (advanced): pulmonary and/or abdominal cohort (2 dose levels), head and neck cohort (2dose levels). 25 patients approximately.

Phase II (advanced STS): errors: α=0.05; β=0.80, option related to efficacy = 50% (ORR in irradiated nodules) (Sample size 9+15), success in ORR of ≤ 25 % will be considered as unacceptable (H0), and would not warrant further investigation (null hypothesis). Success in ORR of ≥ 50% will be considered as an acceptable result warranting further investigation of the investigational drug (H1, alternative hypothesis). A total of 9 eligible and treated patients will be included in the first stage of the study. If ≤ 2 successes are observed, the trial will be stopped in this cohort with the conclusion that the investigational combination should not be further investigated. Else (≥ 3 successes), patients will continue to be accrued until 24 eligible patients enter the study. If 10 or more successes are observed in those 24 patients, it will be concluded that the results of this trial warrant further investigation.

Cohort D (Best scheme of PM14 plus RTP in localized intermediate sarcoma)

Phase I (localized sarcoma): 2 dose levels, 10 patients approximate ly. Phase II (localized "intermediate risk" STS): errors: α=0.05; β=0.80, option related to efficacy = 30% (ORR in irradiated nodules) (Sample size 10+19), success in ORR of ≤ 10% will be considered as unacceptable (H0), and would not warrant further investigation (null hypothesis). Success in ORR of ≥ 30% will be considered as an acceptable result warranting further investigation of the investigational drug (H1, alternative hypothesis). A total of 10 eligible and treated patients will be included in the first stage of the study. If ≤ 1 successes are observed, the trial will be stopped in this cohort with the conclusion that the investigational combination should not be further investigated. Else (≥ 2 successes), patients will continue to be accrued until 29 eligible patients enter the study. If 6 or more successes are observed in those 29 patients, it will be concluded that the results of this trial warrant further investigation.

02

Conditions studied

  • Advanced Soft-tissue Sarcoma
  • Advanced L-sarcomas
  • Other Advanced Sarcomas
  • Advanced Solid Tumor
  • Localized Soft-tissue Sarcoma
03

In context

Lead sponsor

Grupo Espanol de Investigacion en Sarcomas is the lead sponsor of 20 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Cohorts A, B, E, and F

  1. The patient must voluntarily sign the before any study test is conducted that is not part of routine patient care.
  2. Age: 18-75 years.
  3. Patients must have a diagnosis of soft tissue sarcoma with , and not suitable for metastasectomy or surgery resection or not oncologically recommended metastasectomy. A centralized diagnosis confirmation will be performed and the tumor sample must be available and sent prior to inclusion to this end.
  4. A centralized diagnosis of DD liposarcoma or mixoid/hypercellular liposarcoma or leiomyosarcoma must be confirmed for patients in cohort E.
  5. A centralized diagnosis of other sarcomas includes: undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma, synovial sarcoma, malignant peripheral nerve sheath tumors, sarcoma NOS, fibrosarcoma, pleomorphic rhabdomyosarcoma, pleomorphic liposarcoma, epithelioid sarcoma, clear cell sarcoma, dedifferentiated or aggressive features in solitary fibrous tumor, extraskeletal myxoid chondrosarcoma, angiosarcoma, epithelioid hemangioendothelioma,
  6. Patients must have received a previous chemotherapy line in advanced disease unless or not indicated.
  7. Radiological disease progression must be documented within 6 months prior to study entry.
  8. The patient must have been considered eligible for systemic chemotherapy. A maximum of two previous lines for advanced/metastatic disease are allowed.
  9. according to v1.1 criteria.
  10. Performance status ≤1 ().
  11. Adequate bone marrow function ( >10 g/dL, neutrophils ≥ 1,500/mm3, ≥ 100,000/mm3). Patients with ≥ 30 mL/min (Cockcroft and Gault's formula), transaminases ≤ 3.0 times the , total ≤ ULN, are acceptable.
  12. Men or women of must be using an effective method of before entry into the study and throughout the same and for 3 months (men) and 6 months (women) after ending study treatment. Women of childbearing potential must have a negative serum or urine pregnancy test before study entry.
  13. Normal cardiac function with a ≥ 50% by echocardiogram or MUGA.
  14. and serologies must be performed prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).
  15. Patient must have a central venous catheter for PM14 treatment.

Cohort C

  1. The patient must voluntarily sign the informed consent before any study test is conducted that is not part of routine patient care.
  2. Age: 18-75 years.
  3. Patients must have a diagnosis of advanced soft tissue sarcoma, or recurrent head \& neck suitable for reirradiation or other advanced or metastatic solid tumor not suitable for metastasectomy or surgery resection or not oncologically recommended metastasectomy. A centralized diagnosis will be performed and the tumor sample must be available and sent prior to inclusion to this end. For phase II part, onlysoft tissue sarcomas will be enrolled.
  4. Patients must have received a previous chemotherapy line in advanced disease.
  5. Disease distribution must allow meeting with normal tissue constrains of radiation therapy. Radiation oncologist must confirm this point at local sites.
  6. Metastatic spread could be present in several organs (i.e. lungs and pelvic fossa) however, not all the locations have to be irradiated.
  7. Those lesions considered for radiation therapy have to be related to symptoms (for phase II).
  8. It is allowed that not all the lesions will be under radiation fields. As a general rule, the priority is to select, as target-irradiating lesions, those with greater increase in size and those largest lesions if related with symptoms. Irradiating pulmonary lesions with infiltration of pleural serosa is discouraged.
  9. Radiological disease progression must be documented within 6 months prior to study entry.
  10. The patient must have been considered eligible for systemic chemotherapy. A maximum of two previous lines for advanced/metastatic disease are allowed.
  11. The following histological subtypes can be included for the phase II part (central pathology review is mandatory before accrual): undifferentiated pleomorphic sarcoma (UPS), leiomyosarcoma, angiosarcoma, epithelial hemangioendothelioma, liposarcoma and its variants (well differentiated, dedifferentiated, myxoid/round cell, pleomorphic), synovial sarcoma, fibrosarcoma and its variants (epithelial fibrosarcoma/low grade fibromyxoid sarcoma), solitary fibrous tumor, malignant peripheral nerve sheath tumor (MPNST), myxofibrosarcoma, epithelioid sarcoma and (NOS) unclassified sarcoma.
  12. Measurable disease according to RECIST v1.1 criteria.
  13. Performance status ≤1 (ECOG).
  14. Adequate respiratory functions: > 1L; DLco > 40% (patients with pulmonary target lesions).
  15. Adequate bone marrow function (hemoglobin > 10 g/dL, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3). Patients withcreatinine clearance ≥ 30 mL/min (Cockcroft and Gault's formula), transaminases ≤ 2.5 times the ULN, total bilirubin ≤ ULN are acceptable.
  16. Men or women of childbearing potential must be using an effective method of contraception before entry into the study and throughout the same and for 3 months (men) and 6 months (women) after ending study treatment. Women of childbearing potential must have a negative serum or urine pregnancy test before study entry.
  17. Normal cardiac function with a LVEF ≥ 50% by echocardiogram or MUGA.
  18. HBV and HCV serologies must be performed prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).
  19. Patient must have a central venous catheter for PM14 treatment.

Cohort D

  1. The patient must voluntarily sign the informed consent before any study test is conducted that is not part of routine patient care.
  2. Age: 18-75 years.
  3. Patients must have a diagnosis of localized soft tissue sarcoma that lacks one or more of the following risk criteria: G3, deep and > 5 cm. At least G2 is required (i.e. G3, superficial and > 5 cm; or G3 \< 5 cm deep; or G2, deep and > 5 cm, etc.).
  4. Patients must be diagnosed by core- and the elapsed time between biopsy and enrollment must be shorter than 6 weeks.
  5. Patients must be diagnosed by central pathology review with one of the following subtypes: leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma, synovial sarcoma, sarcoma NOS, fibrosarcoma, myxoid liposarcoma,dedifferentiated liposarcoma, solitary fibrous tumor (the formerly malignant subtype).
  6. Only those sarcomas of limbs or trunk wall will be eligible for this cohort.
  7. Disease distribution allows meeting with normal tissue constraints of radiation therapy. Radiation oncologist must confirm this point at local sites.
  8. Patients must have resectable primary tumor while it is allowed to enroll patients with metastatic spread that could be potentially resectable.
  9. Patients must have criteria of operability for the primary tumor.
  10. The patient must have been considered eligible for systemic chemotherapy.
  11. Measurable disease according to RECIST v1.1 criteria.
  12. Patients have to be candidates for MRI test.
  13. Performance status ≤ 1 (ECOG).
  14. Adequate bone marrow function (hemoglobin > 10 g/dL, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3). Patients withcreatinine clearance ≥ 30 mL/min (Cockcroft and Gault's formula), transaminases ≤ 2.5 times the ULN, total bilirubin ≤ ULN are acceptable.
  15. Men or women of childbearing potential must be using an effective method of contraception before entry into the study and throughout the same and for 3 months (men) and 6 months (women) after ending study treatment. Women of childbearing potential must have a negative serum or urine pregnancy test before study entry.
  16. Normal cardiac function with a LVEF ≥ 50% by echocardiogram or MUGA.
  17. It should be performed HBV and HCV serologies prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).
  18. Patient must have a central venous catheter for treatment with PM14.

Exclusion criteria

Exclusion Criteria:

Cohorts A, B, E, and F

  1. Performance status ≥ 2 ().
  2. Plasma > .
  3. Creatinine > 1.6 mg/dL.
  4. History of other cancer with less than 5 years free of disease with the exception of adequately treated basal cell carcinoma or in situ cervical cancer.
  5. Patients who do not provide consent for mandatory biological samples (including those required for the translational study) cannot participate in the study.
  6. Significant cardiovascular disease (for example, dyspnea > 2 ).
  7. Significant systemic diseases grade 3 or higher on the v5.0 scale, that limit patient availability, or according to investigator judgment may significantly contribute to treatment toxicity.
  8. Uncontrolled bacterial, mycotic or viral infections.
  9. Women who are pregnant or breastfeeding.
  10. Psychological, family, social or geographic circumstances that limit the patients' ability to comply with the protocol or .
  11. Patients participating in another clinical trial or receiving any other product.
  12. Patients who had participated in another clinical trial and/or had received any other investigational product in the last 30 days prior to inclusion.
  13. Histologies other than those described in the inclusion criteria.

Cohort C

  1. Previous treatment with radiotherapy (except if previous radiotherapy treatment plus planned study radiotherapy treatment allow tissue constrains).
  2. Performance status ≥ 2 (ECOG).
  3. Plasma bilirubin > ULN.
  4. Creatinine > 1.6 mg/dL.
  5. History of other cancer with less than 5 years free of disease with the exception ofadequately treated basal cell carcinoma or in situ cervical cancer.
  6. Severe or other severe pulmonary diseases.
  7. Significant cardiovascular disease (for example, dyspnea > 2 NYHA).
  8. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v5.0 scale, that limit patient availability, or according to investigator judgment may significantly contribute to treatment toxicity.
  9. Patients who do not provide consent for mandatory biological samples (including those required for the translational study) cannot participate in the study.
  10. Uncontrolled bacterial, mycotic or viral infections.
  11. Women who are pregnant or breastfeeding.
  12. Psychological, family, social or geographic circumstances that limit the patients' ability to comply with the protocol or informed consent.
  13. Patients participating in another clinical trial or receiving any other investigational product.
  14. Patients who had participated in another clinical trial and/or had received any other investigational product in the last 30 days prior to inclusion.
  15. Histologies other than those described in inclusion criteria.

Cohort D

  1. High-risk localized patients are not allowed to be enrolled (those G3, deep, and larger than 5 cm or those with risk of death at least 40% by sarculator nomogram).
  2. Previous treatment with radiotherapy.
  3. Primary tumor location other than those indicated in the inclusion criteria.
  4. Histological subtypes other than those indicated in the inclusion criteria.
  5. Unresectable or inoperable primary tumor.
  6. Patients who do not provide consent for mandatory biological samples (including those required for the translational study) cannot participate in the study.
  7. Performance status ≥ 2 (ECOG).
  8. Plasma bilirubin > ULN.
  9. Creatinine > 1.6 mg/dL.
  10. History of other cancer with less than 5 years free of disease with the exception of adequately treated basal cell carcinoma or in situ cervical cancer.
  11. Significant cardiovascular disease (for example, dyspnea > 2 NYHA).
  12. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v5.0 scale, that limit patient availability, or according to investigator judgment may significantly contribute to treatment toxicity.
  13. Uncontrolled bacterial, mycotic or viral infections.
  14. Women who are pregnant or breastfeeding.
  15. Psychological, family, social or geographic circumstances that limit the patients' ability to comply with the protocol or informed consent.
  16. Patients participating in another clinical trial or receiving any other investigational product.
  17. Patients who had participated in another clinical trial and/or had received any other investigational product in the last 30 days prior to inclusion.
Terms in these criteria, in plain language(22)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
195 participants (estimated)

Study arms

  • Experimental
    PM14 in monotherapy and in combination with radiotherapy in STS and other solid tumors

    Cohort A : Phase I. PM14 24-h IV 21-d cycles, up to PD or toxicity. Dexamethasone recommended. Cohort B: Phase I. PM14 3-h IV infusion 3 d 21-d cycles, up to PD or toxicity. Dexamethasone recommended. Cohort E: PM14 at RP2D. Dexamethasone recommended. 21-d cycles up to PD or toxicity. Cohort F: PM14 at the RP2D. Dexamethasone recommended. 21-d cycles up to PD or toxicity. Cohort C: Phase I: PM14 at the RP2D, 21-d cycles in combination with radiotherapy, up to PD or toxicity. Dexamethasone recommended. Radiation therapy 3Gy/f 10 d. Phase II: PM14 at RP2D with radiation therapy. Cohort D: Phase I: PM14 at the RP2D, 3 x 21-d cycles in neoadjuvant setting, in combination with radiotherapy. Dexamethasone recommended. Radiation therapy 1.8Gy/f 25 d. Phase II: PM14 at RP2D with radiation therapy.

    Drug: PM14

Interventions

  • DrugPM14

    Pharmaceutical form: PM14 drug product is provided as a sterile lyophilized powder for concentrate for solution for infusion with a strength of 5.0 mg of the active moiety. Route of administration: PM14 drug product was developed for administration by the i.v. route. Before use, the vials are reconstituted with 10 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion to give a solution containing 0.5 mg/mL of PM14. Prior to administration, the reconstituted DP solution should be further diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion. Each vial of PM14 5.0 mg is a single use vial.

06

What researchers measure

Primary outcomes

  1. Cohorts A, B, C To determine the maximum tolerated dose (MTD) of PM14 to be used as recommended phase 2 dose (RP2D).

    The MTD will be determined by assessing adverse events according to CTCAE v5.0 and they will be used as a rule for escalating or diminishing dose levels according to the dose-limiting toxicities detailed in the protocol.

    Time frame: 1 year

  2. Cohorts E and F To evaluate the progression-free survival rate (PFSR) at 6 months.

    PFSR-6m (according to central radiology review): Efficacy measured by the PFSR at 6 months, which is defined as the percentage of patients whodid not experience radiological progression according to RECIST v1.1 or death due to any cause since the date of enrollment until month 6 after date of enrollment

    Time frame: 6 months

  3. Cohort C phase I To determine the maximum tolerated dose (MTD) of PM14 to be used as recommended phase 2 dose (RP2D).

    The MTD will be determined by assessing adverse events according to CTCAE v5.0 and they will be used as a rule for escalating or diminishing dose levels according to the dose-limiting toxicities detailed in the pro

    Time frame: 1 year

  4. Cohort C phase II To evaluate the overall response rate (ORR) in irradiated nodules only.

    This objective is considered as a surrogate of palliative relief. Overall response rate (ORR) (according to central radiology review): Efficacy measured by ORR, which is defined as the number of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable patients (according to RECIST v1.1). Only nodules included in the radiation field will be considered.

    Time frame: 8 weeks

  5. Cohort D phase I To determine the maximum tolerated dose (MTD) of PM14 to be used as recommended phase 2 dose (RP2D).

    The MTD will be determined by assessing adverse events according to CTCAE v5.0 and they will be used as a rule for escalating or diminishing dose levels according to the dose-limiting toxicities detailed in the protocol.

    Time frame: 1 year

  6. Cohort D phase II To evaluate the overall response rate (ORR).

    Overall response rate (ORR) (according to central radiology review): Efficacy measured by ORR, which is defined as the number of patients with a best overall response (BOR) of complete response(CR)or partial response (PR) divided by the number of response evaluable patients (according to RECIST v1.1).

    Time frame: 63 days

Secondary outcomes

  1. Cohorts A, B, E, F, C, D To evaluate the safety profile

    Toxicity will be assessed by adverse events related to study drugs, detected through physical examinations and laboratory tests, and graded according to CTCAE v5.0.

    Time frame: 21 days

  2. Cohorts A, B, E, F, C, D To evaluate the overall response rate (ORR).

    Overall response rate (ORR) (according to central radiology review): Efficacy measured by ORR, which is defined as the number of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of responseevaluable patients (according to RECIST v1.1).

    Time frame: 8 weeks

  3. Cohorts A, B, C, D To evaluate the median of progression-free survival (mPFS).

    mPFS (according to central radiology review): Efficacy measured by mPFS, which is defined as the median of time in months from date of enrollment to date of radiological progression according to RECIST v1.1 or to date of death due to any cause, whatever occurs first.

    Time frame: 8 weeks

  4. Cohorts A, B, E, F, C To evaluate quality of life.

    Quality of life: Assessed by using the European Organization for Cancer Research and Treatment quality of life questionnaire (EORTC QLQ-C30). For the completion of the QLQ-C30 questionnaire, values between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: very much) are assigned according to the patient's responses to the item, only in items 29 and 30 are They evaluate with a score of 1 to 7 (1: very poor, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales. High values on the global health and function status scales indicate a better quality of life (QoL), while on the symptom scale it would indicate a decrease in QoL since it indicates the presence of symptoms associated with cancer.

    Time frame: 3 weeks

  5. Cohorts A, B, E, F, C, D To contribute to translational studies.

    The clinical study will provide tumor and blood samples for the translational research program.

    Time frame: 4 years

  6. Cohorts A and B To characterize the PK of PM14 in the explored regimens.

    The clinical study will provide blood samples for the measurement of PM14 concentration and baseline α-1-acid glycoprotein (AAG) levels.

    Time frame: 1 year

  7. Cohorts E, F, C To evaluate the median of overall survival (mOS).

    mOS: Efficacy measured by mOS, which is defined as the median of time in months from dateof enrollment to date of death due to any cause.

    Time frame: 3 months

  8. Cohort C phase II To evaluate variations in pain.

    Changes in pain: Variations in pain will be measured by the Brief Pain Inventory - Short Form (BPI-SF).

    Time frame: 3 weeks

  9. Cohort C phase II To evaluate variations in analgesic use.

    Changes in analgesic use: Variations in analgesic use will be measured by the Analgesic Quantification Algorithm (AQA).

    Time frame: 3 weeks

  10. Cohort C phase II To evaluate the time to progression (TTP) of the irradiated nodules.

    Time to progression (TTP) of irradiated nodules (according to central radiology review): TTP is defined as the time in months between the date of enrollment and the date of progression of irradiated nodules (not including deaths) (according to RECIST v1.1 criteria).

    Time frame: 3 weeks

  11. Cohort C phase II To evaluate the progression-free survival rate (PFSR) at 6 months.

    PFSR-6m (according to central radiology review): Efficacy measured by the PFSR at 6 months, which is defined as the percentage of patients whodid not experience radiological progression according to RECIST v1.1 or death due to any cause since the date of enrollment until month 6 after date of enrollment.

    Time frame: 6 months

  12. Cohort C phase II, D To evaluate the pathological response.

    Pathological response: Assessed using a predefined surgical specimen pathology form and method describing the precise percentage of tumor non-viable histological changes (hyalinosis, necrosis, cyst, differentiation etc) and percentage of viable tumor.

    Time frame: 8 weeks

  13. Cohort D phase II To evaluate relapse-free survival (RFS) at 3 years.

    Relapse-free survival (RFS) at 3 years: Efficacy measured by RFS at 3 years, which is defined as the percentage of patients who did not experience relapse since date of surgery until year 3 after date of surgery.

    Time frame: 3 years

  14. Cohort D phase II To evaluate changes in MRI diffusion/perfusion parameters (exploratory).

    MRI imaging will be evaluated to assess variations in diffusion/perfusion parameters (exploratory)

    Time frame: 63 days

07

Study locations

4 of 4 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2021 (actual). Primary completion is estimated for Nov 2025, 48 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 12, 2021
First posted
Dec 6, 2021
StartActual
Nov 23, 2021
Primary completionEst.
Nov 30, 2025
CompletionEst.
May 31, 2026
Last update
Mar 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05146440
Lead sponsor
Grupo Espanol de Investigacion en Sarcomas
Responsible party
Sponsor
First posted
Dec 6, 2021
Start date
Nov 23, 2021
Primary completion
Nov 30, 2025 (estimated)
Completion
May 31, 2026 (estimated)
Last update
Mar 21, 2025

Study contacts

Patricio Ledesma
Contact
ensayos@sofpromed.com
971 439 900 ext. +34
Claudia Marcote
Contact
cmarcote@sofpromed.com
971 439 900 ext. +34
Javier Martín Broto
study director · Hospital Universitario Fundación Jiménez Díaz
Javier Martínez Trufero
principal investigator · Hospital Miguel Servet
Ana Sebio
principal investigator · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Claudia Valverde
principal investigator · Hospital Vall d'Hebron

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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