RecruitingPhase 1Phase 2NCT05146440

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

Phase Ib/II Multicohort Trial of Different Schemes of PM14 in Monotherapy and in Combination with Radiotherapy in Soft Tissue Sarcomas and Other Solid Tumors

Sponsor

Grupo Espanol de Investigacion en Sarcomas

Enrollment

195 participants

Start Date

Nov 23, 2021

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called PM14 — alone and in combination with radiation therapy — in patients with soft tissue sarcomas (a type of cancer affecting muscle, fat, or connective tissue) and other solid tumors that have spread or cannot be removed with surgery. Multiple treatment groups (cohorts) are being studied. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with a soft tissue sarcoma or other eligible solid tumor - Your cancer has progressed or spread and you have already tried at least one prior chemotherapy - You are in good health (ECOG performance status 0 or 1) - Your blood counts, kidney, and liver function meet the required minimums - You are willing to use contraception throughout the study **You may NOT be eligible if...** - You are in poor health (ECOG 2 or higher) - You have uncontrolled infection or serious heart or lung disease - You are pregnant or breastfeeding - You have had more than two prior chemotherapy lines for your advanced disease - You have had another cancer in the past 5 years (with some exceptions like treated skin cancer) - You are participating in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.