Clinical Trial of PM54 in Advanced Solid Tumors Patients.

Part of paid clinical trials in San Antonio, Texas.

Sponsor
PharmaMar
Study ID
NCT05841563
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PM54 — DRUG
    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 Details

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.

Key Dates

Start date
Apr 28, 2023
Status verified
Sep 2025
Primary completion
Dec 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
125 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PM54
    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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
South Texas Accelerated Research TherapeuticsSan AntonioTexas78229-3307
Kyriakos P Papadopoulos

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South Texas Accelerated Research Therapeutics· San Antonio, TX

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