Actively Recruiting
Multicohort Trial of Different Schemes of PM14 in Monotherapy and in Combination with Radiotherapy in Soft Tissue Sarcomas and Other Solid Tumor
Led by Grupo Espanol de Investigacion en Sarcomas · Updated on 2025-03-21
195
Participants Needed
4
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multicohort Trial of Different Schemes of PM14 in Monotherapy and in Combination with Radiotherapy in Soft Tissue Sarcomas and Other Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years.
- Signed informed consent before any study procedures.
- Diagnosis of soft tissue sarcoma or specified sarcoma subtypes confirmed by central pathology.
- Metastatic or localized disease as defined per cohort.
- Prior chemotherapy for advanced disease unless contraindicated.
- Radiological disease progression within 6 months before study entry.
- Eligible for systemic chemotherapy with up to two prior lines allowed.
- Measurable disease by RECIST v1.1 criteria.
- Performance status of 0 or 1 (ECOG).
- Adequate bone marrow, kidney, liver, and cardiac function.
- Negative pregnancy test for women of childbearing potential.
- Use of effective contraception during and after study treatment.
- Negative HBV and HCV tests or managed infection status.
- Presence of a central venous catheter for PM14 administration.
- For radiotherapy cohorts, disease and lesion characteristics suitable for radiation treatment.
- For localized sarcoma cohort, resectable primary tumor and eligibility for MRI scans.
You will not qualify if you...
- Performance status of 2 or higher (ECOG).
- Elevated plasma bilirubin above normal limits.
- Creatinine level above 1.6 mg/dL.
- History of other cancers within the last 5 years except treated basal cell carcinoma or cervical cancer.
- Refusal to provide mandatory biological samples.
- Significant cardiovascular disease such as severe dyspnea.
- Severe systemic diseases grade 3 or higher limiting participation or increasing toxicity risk.
- Uncontrolled infections (bacterial, fungal, viral).
- Women who are pregnant or breastfeeding.
- Psychological, social, or geographic factors limiting compliance.
- Participation in another clinical trial or recent investigational treatment within 30 days.
- Histological subtypes not listed in inclusion criteria.
- Prior radiotherapy not compatible with study protocol.
- High-risk localized sarcoma patients (specific grading and size criteria).
- Unresectable or inoperable primary tumors.
- Tumor locations outside those allowed for the study.
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Hospital Universitario Miguel Servet
Zaragoza, Aragon, Spain, 50009
Actively Recruiting
2
Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
3
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain, 08041
Actively Recruiting
4
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain, 28040
Actively Recruiting
Research Team
P
Patricio Ledesma
CONTACT
C
Claudia Marcote
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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