Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04478279
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2020-07-02
Brief Title:
A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors
Sponsor:
Sapience Therapeutics
Organization:
Sapience Therapeutics
Study Overview
Official Title:
A Phase 1-2 Dose-escalation and Expansion Study of ST101 in Patients With Advanced Unresectable and Metastatic Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
This is an open-label two-part phase 1-2 dose-finding study designed to determine the safety tolerability PK PD and proof-of-concept efficacy of ST101 administered IV in patients with advanced solid tumors The study consists of two phases a phase 1 dose escalationregimen exploration phase and a phase 2 expansion phase
Detailed Description:
Dose escalation regimen exploration phase During the dose escalationregimen exploration phase only patients diagnosed with locally advanced or metastatic melanoma carcinoma or sarcoma of any tumor type who are refractory or intolerant to all available therapies that would impact survival will be enrolled
ST101 will be administered intravenously IV initially once per week The dose escalation cohorts will be recruited using a standard 33 design At each new dosing cohort there will be a 1-week observation period after dosing the first patient in order to assess safety prior to dosing the remainder of the patients in that cohort The dose cohorts will be 05 1 2 4 8 and 16 mgkg with once weekly QW dosing in all cohorts except for the highest dose level which will be dosed every other week Q2W
The expansion phase consists of 4 specific tumor-type cohorts which each follow the same Simon 2-stage design Fifteen 15 patients will be enrolled in each cohort and treated with the ST101 RP2D If one or more responses is observed that cohort will be expanded to a total of 30 patients to further assess efficacy
Responses will be graded using response evaluation criteria in solid tumors RECIST 11 Eisenhauer 2009 for hormonal receptor positive HRpos locally advancedmetastatic breast cancer LAMBC and melanoma modified response assessment in neuro-oncology RANO Ellingson 2017 for GBM and prostate cancer clinical trials working group 3 PCWG3 Scher 2016 for castration-resistant prostate cancer CRPCDuring the expansion phase only patients diagnosed with the following tumor types will be allowed into this phase of the study
HRpos LAMBC that has progressed after prior 1-2 hormone-based therapies Previous treatment with cyclin-dependent kinase 46 CDK46 inhibitor mammalian target of rapamycin mTOR inhibitor or chemotherapy is allowed as monotherapy or in combination
Melanoma that has progressed afteror on treatment with an immune checkpoint inhibitor CPI and have received 1-2 prior lines of therapy for their advancedmetastatic disease Patients that have BRAF mutated disease should also have received one line of appropriate targeted therapy
Primary de novo GBM that has recurred or progressed per modified RANO criteria after 1 standard treatment regimen Standard therapy is defined as maximal surgical resection radiotherapy and concomitant temozolomide with radiotherapy or adjuvant chemotherapy with temozolomide Patients that undergo tumor treating fields as an adjuvant to first line therapy are allowed
CRPC that has progressed after previous treatment with taxanes abiraterone and enzalutamideapalutamide
The tumor types in the expansion phase may change based on emerging data from the dose escalation phase of this study Additional mini cohorts of 10 patients may be added to the expansion phase based on efficacy signals during the dose escalation phase
ST101 will be administered intravenously IV initially once per week The dose escalation cohorts will be recruited using a standard 33 design At each new dosing cohort there will be a 1-week observation period after dosing the first patient in order to assess safety prior to dosing the remainder of the patients in that cohort The dose cohorts will be 05 1 2 4 8 and 16 mgkg with once weekly QW dosing in all cohorts except for the highest dose level which will be dosed every other week Q2W
The expansion phase consists of 4 specific tumor-type cohorts which each follow the same Simon 2-stage design Fifteen 15 patients will be enrolled in each cohort and treated with the ST101 RP2D If one or more responses is observed that cohort will be expanded to a total of 30 patients to further assess efficacy
Responses will be graded using response evaluation criteria in solid tumors RECIST 11 Eisenhauer 2009 for hormonal receptor positive HRpos locally advancedmetastatic breast cancer LAMBC and melanoma modified response assessment in neuro-oncology RANO Ellingson 2017 for GBM and prostate cancer clinical trials working group 3 PCWG3 Scher 2016 for castration-resistant prostate cancer CRPCDuring the expansion phase only patients diagnosed with the following tumor types will be allowed into this phase of the study
HRpos LAMBC that has progressed after prior 1-2 hormone-based therapies Previous treatment with cyclin-dependent kinase 46 CDK46 inhibitor mammalian target of rapamycin mTOR inhibitor or chemotherapy is allowed as monotherapy or in combination
Melanoma that has progressed afteror on treatment with an immune checkpoint inhibitor CPI and have received 1-2 prior lines of therapy for their advancedmetastatic disease Patients that have BRAF mutated disease should also have received one line of appropriate targeted therapy
Primary de novo GBM that has recurred or progressed per modified RANO criteria after 1 standard treatment regimen Standard therapy is defined as maximal surgical resection radiotherapy and concomitant temozolomide with radiotherapy or adjuvant chemotherapy with temozolomide Patients that undergo tumor treating fields as an adjuvant to first line therapy are allowed
CRPC that has progressed after previous treatment with taxanes abiraterone and enzalutamideapalutamide
The tumor types in the expansion phase may change based on emerging data from the dose escalation phase of this study Additional mini cohorts of 10 patients may be added to the expansion phase based on efficacy signals during the dose escalation phase
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