The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: PM14 Administered Intravenously to Patients With Advanced Solid Tumors
Official Title: Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM14 Administered Intravenously to Patients With Advanced Solid Tumors
Study ID: NCT05076396
Brief Summary: Despite recent advances in the treatment of solid tumors in general, advanced (metastatic) disease remains mostly incurable and there is an urgent need to develop new therapeutic options for these patients, particularly investigational drugs with novel mechanisms of action. The investigation of new combination regimens of non-crossresistant agents with acceptable-and not completely overlapping-toxicities has been a major way to improve response rate and outcome of patients with advanced solid tumors.
Detailed Description: First-in-human, open-label, dose-finding, phase I trial, using a classical 3+3 design followed by a continual reassessment method (CRM). Patients will be included in cohorts of a minimum of three or six patients to receive PM14 at successively increasing dose levels, starting at 0.25 mg/m\^2 for the Days 1 and 8 schedule. For the Day 1 schedule, the starting dose will be 4.5 mg/m\^2. Dose escalation will proceed only after all the patients fully evaluable for DLT included at one dose level have completed the first cycle (i.e., three weeks). Once the RD has been determined, expansion cohorts will be included to have a minimum of 20 fully evaluable patients per indication (tumor type) treated in the Expansion phase (regardless of the schedule administered), and thus have an adequate number of patients to assess safety. The indications of these patients will be chosen depending on the efficacy data obtained during dose escalation. Patients treated at the expansion cohorts will be evaluable by the Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) and/or by serum markers only in patients with prostate cancer (prostate specific-antigen \[PSA\]) or ovarian cancer (carbohydrate antigen-125 \[CA-125\]) according to the Prostate-Specific Antigen Working Group Recommendations (PSAWGR) and the Gynecologic Cancer Intergroup (GCIG) specific criteria, respectively.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Massachusetts General Hospital, Boston, Massachusetts, United States
MD Anderson Cancer Center, Houston, Texas, United States
Gustave Roussy, Villejuif, París, France
Hospital Universitari Vall d'Hebron, Barcelona, Cataluña, Spain
Hospital General Universitario Gregorio Marañón, Madrid, Comunidad De Madrid, Spain
Clinica Universidad de Navarra, Madrid, Comunidad De Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, Comunidad De Madrid, Spain
Hospital Universitario 12 de Octubre, Madrid, Comunidad De Madrid, Spain
Hospital Universitario Madrid Sanchinarro, Madrid, Comunidad De Madrid, Spain