PM14 Administered Intravenously to Patients With Advanced Solid Tumors (NCT05076396) | Clinical Trial Compass
CompletedPhase 1
PM14 Administered Intravenously to Patients With Advanced Solid Tumors
United States, France, Spain126 participantsStarted 2017-09-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntarily signed and dated written informed consent (IC), obtained prior to any specific study procedure.
✓. Age ≥18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
✓. Tumors with deleterious germline BRCA mutation: epithelial ovarian cancer (including primary peritoneal and fallopian tube cancer), breast cancer, pancreatic cancer, prostate cancer, or any other malignancies.
✓. Epithelial ovarian cancer (including primary peritoneal and fallopian tube cancer) with no deleterious germline BRCA mutations or with unknown BRCA status.
Exclusion criteria
✕. Concomitant diseases/conditions:
✕. Increased cardiac risk:
✕. Active infection requiring systemic treatment.
✕. Known human immunodeficiency virus (HIV) or known hepatitis C virus (HCV) infection or active hepatitis B.
✕. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study (e.g., COVID-19).
✕. Symptomatic, high dose steroid-requiring, and progressing central nervous system (CNS) disease. Exceptions will be made for (i) patients who have completed radiotherapy at least four weeks prior to inclusion (asymptomatic, non-progressing patients taking steroids in the process of already being tapered within two weeks prior to inclusion), and (ii) patients with asymptomatic brain metastasis without need for radiotherapy or steroids.
✕. Patients with carcinomatous meningitis regardless of clinical stability.
✕. Prior bone marrow or stem cell transplantation, or radiation therapy in more than 35% of bone marrow.