This is a study of OT-101, a TGF-b2 inhibitor in combination of pembrolizumab in patients with malignant pleural mesothelioma. Both efficacy assessment, and safety and tolerability of various dose of OT-101 in combination of pembrolizumab are evaluated.
Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of Malignant Pleural Mesothelioma will be enrolled in this study.
Male participants: A male participant must agree to use contraception as detailed in Appendix 4 of this protocol during the treatment period and for at least 90 days, corresponding to time needed to eliminate any study treatment(s) (e.g. 5 terminal half-lives for pembrolizumab) plus an additional 90 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period.
Not a woman of childbearing potential (WOCBP) OR
A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 90 days/weeks corresponding to time needed to eliminate any study treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity after the last dose of study treatment.
A WOCBP who has a positive urine pregnancy test within 72 hours prior to agent administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has received prior systemic anti-cancer therapy including investigational agents within 28 days prior to study therapy.
Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
Single group
OT-101
DrugOT-101 in combination of pembrolizumab
Determination of ORR for the combination of OT-101 and pembrolizumab in subjects
modified RECIST (mRECIST; v1.1)
PFS, DOR and 6-month and 12-month Overall Survival (OS) will be estimated in all subjects in the ITT population.
Progression-free Survival (PFS), defined as the time from date of first dose of study drug to date of documented PD based on modified RECIST v1.1. Duration of Response (DOR), defined as the time from date of first documented response (CR or PR) to date of documented progressive disease (PD), based on modified RECIST v1.1. Overall Survival (OS), defined as the time from the date of first dose of study drug to the date of death.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
