Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04706962
Status:
RECRUITING
Last Update Posted:
2023-12-04
First Post:
2021-01-07
Brief Title:
TH1902 in Patients With Advanced Solid Tumors
Sponsor:
Theratechnologies
Organization:
Theratechnologies
Study Overview
Official Title:
A Phase 1 Open-Label Dose Escalation and Expansion Study of TH1902 in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Open label first-in-human study of TH1902 in solid cancer with 4 sequential parts
Part 1 dose escalation patients with recurrent advanced solid tumors all comers that have relapsed or are refractory to standard chemotherapy surgery radiation therapy and for which no known effective therapies exist
Part 2 expansion selected patient populations with recurrent advanced TNBC HR breast cancer epithelial ovarian cancer endometrial cancer cutaneous melanoma thyroid cancer SCLC prostate cancer and other cancers known to express SORT1 that are refractory to standard therapy
Part 3 optimization patients diagnosed with histologically or cytologically confirmed high grade serous ovarian cancer including high grade peritoneal or fallopian tube cancer or high grade endometrioid cancer that is refractory or resistant to standard therapies should not be considered platinum sensitive and where current therapy is not considered to be providing benefit
Part 4 basket expansion selected cancer type diagnosed with histologically or cytologically confirmed cancers where TH1902 has been studied andor showed activity in Parts 1 to 3 that is refractory or resistant to standard therapies and where current therapy is not considered to be providing benefit
Part 1 dose escalation patients with recurrent advanced solid tumors all comers that have relapsed or are refractory to standard chemotherapy surgery radiation therapy and for which no known effective therapies exist
Part 2 expansion selected patient populations with recurrent advanced TNBC HR breast cancer epithelial ovarian cancer endometrial cancer cutaneous melanoma thyroid cancer SCLC prostate cancer and other cancers known to express SORT1 that are refractory to standard therapy
Part 3 optimization patients diagnosed with histologically or cytologically confirmed high grade serous ovarian cancer including high grade peritoneal or fallopian tube cancer or high grade endometrioid cancer that is refractory or resistant to standard therapies should not be considered platinum sensitive and where current therapy is not considered to be providing benefit
Part 4 basket expansion selected cancer type diagnosed with histologically or cytologically confirmed cancers where TH1902 has been studied andor showed activity in Parts 1 to 3 that is refractory or resistant to standard therapies and where current therapy is not considered to be providing benefit
Detailed Description:
This first-in-human study was initially designed as a Phase 1 multi-center open-label study with 2 sequential parts in which TH1902 was administered once every 3 weeks Q3W
Part 1 dose escalation was comprised of 18 patients with recurrent advanced solid tumors all comers that had relapsed or were refractory to standard chemotherapy surgery radiation therapy and for which no known effective therapies existed
Part 2 dose expansion was comprised of 18 patients from selected populations with recurrent advanced TNBC HR breast cancer epithelial ovarian cancer endometrial cancer cutaneous melanoma thyroid cancer SCLC prostate cancer and other cancers known to express SORT1 that are refractory to standard therapy
Following emerging data from Parts 1 and 2 the Sponsor has made the decision to pause the enrollment of patients in Part 2 of the study and revisit the study design to improve the risk-benefit ratio Patients who were enrolled in Part 2 of the study that are still benefiting from TH1902 administration will continue following the protocol for Part 2 The study will resume with enrollment in Part 3 and TH1902 will be administered on 3 consecutive weeks followed by 1 week of rest 31 ie on Days 1 8 and 15 of a 28-day cycle and in the following population
Part 3 dose optimization will comprise approximately 16 patients diagnosed with histologically or cytologically confirmed high grade serous ovarian cancer including high grade peritoneal or fallopian tube cancer or high grade endometrioid cancer that is refractory or resistant to standard therapies should not be considered platinum sensitive and where current therapy is not considered to be providing benefit
Upon completion of Part 3 an ad hoc interim analysis will be conducted to select at least 2 dosing arms that will offer an acceptable risk-benefit ratio for dose expansion in Part 4 with the following population
Part 4 basket expansion will comprise approximately 20 patients per dose level per selected cancer type diagnosed with histologically or cytologically confirmed cancers where TH1902 has been studied andor showed activity in Parts 1 to 3 that is refractory or resistant to standard therapies and where current therapy is not considered to be providing benefit
Part 1 dose escalation was comprised of 18 patients with recurrent advanced solid tumors all comers that had relapsed or were refractory to standard chemotherapy surgery radiation therapy and for which no known effective therapies existed
Part 2 dose expansion was comprised of 18 patients from selected populations with recurrent advanced TNBC HR breast cancer epithelial ovarian cancer endometrial cancer cutaneous melanoma thyroid cancer SCLC prostate cancer and other cancers known to express SORT1 that are refractory to standard therapy
Following emerging data from Parts 1 and 2 the Sponsor has made the decision to pause the enrollment of patients in Part 2 of the study and revisit the study design to improve the risk-benefit ratio Patients who were enrolled in Part 2 of the study that are still benefiting from TH1902 administration will continue following the protocol for Part 2 The study will resume with enrollment in Part 3 and TH1902 will be administered on 3 consecutive weeks followed by 1 week of rest 31 ie on Days 1 8 and 15 of a 28-day cycle and in the following population
Part 3 dose optimization will comprise approximately 16 patients diagnosed with histologically or cytologically confirmed high grade serous ovarian cancer including high grade peritoneal or fallopian tube cancer or high grade endometrioid cancer that is refractory or resistant to standard therapies should not be considered platinum sensitive and where current therapy is not considered to be providing benefit
Upon completion of Part 3 an ad hoc interim analysis will be conducted to select at least 2 dosing arms that will offer an acceptable risk-benefit ratio for dose expansion in Part 4 with the following population
Part 4 basket expansion will comprise approximately 20 patients per dose level per selected cancer type diagnosed with histologically or cytologically confirmed cancers where TH1902 has been studied andor showed activity in Parts 1 to 3 that is refractory or resistant to standard therapies and where current therapy is not considered to be providing benefit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None