Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513624
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
ETC-159 In Combination With Pembrolizumab In Advanced MSSpMMR Ovarian Cancers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1B Investigator Initiated Study To Evaluate The Preliminary Activity Safety And Tolerability Of ETC-159 In Combination With Pembrolizumab In Advanced MSSpMMR Ovarian Cancers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETC-159-02
Brief Summary:
This is an open-label single-arm investigator-initiated study conceived as a dose expansion cohort of the study D3-002 which evaluated ETC-159 in combination with pembrolizumab in solid tumors
Detailed Description:
Hypothesis
Wnt pathway inhibition with ETC-159 in combination PD1 checkpoint inhibition is safe and effective for the treatment of patients with advanced MSSpMMR ovarian cancerIt is hypothesized that ETC-159 as a selective PORCNi will lead to increased immune infiltration and therefore may turn cold tumors into hot tumors that may then be responsive to checkpoint inhibitor
Primary Objectives
1 To evaluate the preliminary clinical activity of ETC-159 in combination with pembrolizumab according to RECIST v11 in patients with advanced or metastatic platinum-resistant MSSpMMR ovarian cancer
2 To assess the safety of ETC-159 at the dose of 8 mg every other day the recommended dose RD identified in safety segment in combination with pembrolizumab
Secondary Objectives
1 To further assess the efficacy of ETC-159 in combination with pembrolizumab
2 To evaluate the PK of ETC-159 in combination with pembrolizumab in patients
Exploratory Objectives
1 To evaluate the effect of ETC-159 administered orally every other day in combination with pembrolizumab with bone protective treatment denosumab and subsequently zoledronic acid if no response is observed with denosumab on bone turnover markers as potential downstream markers of Wnt signaling β-CTX
2 To correlate available tumor genomic profile with clinical data
3 To evaluate the effect of ETC-159 treatment on
Pharmacodynamic biomarker Axin2 mRNA expression levels in hair follicles
Gene expression levels and PD-L1 protein expression measured in FFPE-tumor tissue if sufficient tissue is available
4 To determine change in serum levels of cancer antigen 125 CA-125
Wnt pathway inhibition with ETC-159 in combination PD1 checkpoint inhibition is safe and effective for the treatment of patients with advanced MSSpMMR ovarian cancerIt is hypothesized that ETC-159 as a selective PORCNi will lead to increased immune infiltration and therefore may turn cold tumors into hot tumors that may then be responsive to checkpoint inhibitor
Primary Objectives
1 To evaluate the preliminary clinical activity of ETC-159 in combination with pembrolizumab according to RECIST v11 in patients with advanced or metastatic platinum-resistant MSSpMMR ovarian cancer
2 To assess the safety of ETC-159 at the dose of 8 mg every other day the recommended dose RD identified in safety segment in combination with pembrolizumab
Secondary Objectives
1 To further assess the efficacy of ETC-159 in combination with pembrolizumab
2 To evaluate the PK of ETC-159 in combination with pembrolizumab in patients
Exploratory Objectives
1 To evaluate the effect of ETC-159 administered orally every other day in combination with pembrolizumab with bone protective treatment denosumab and subsequently zoledronic acid if no response is observed with denosumab on bone turnover markers as potential downstream markers of Wnt signaling β-CTX
2 To correlate available tumor genomic profile with clinical data
3 To evaluate the effect of ETC-159 treatment on
Pharmacodynamic biomarker Axin2 mRNA expression levels in hair follicles
Gene expression levels and PD-L1 protein expression measured in FFPE-tumor tissue if sufficient tissue is available
4 To determine change in serum levels of cancer antigen 125 CA-125
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None