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A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors

Primary Purpose

Breast Cancer Metastatic, Pancreatic Cancer, NSCLC, Metastatic

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ST316
Sponsored by
Sapience Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Able and willing to sign ICF and comply with the protocol and the restrictions and assessments therein. Male or female โ‰ฅ18 years of age. ECOG performance status 0-1. Must have a locally advanced or metastatic inoperable tumor as follows: For the dose escalation/regimen exploration phase: CRC, BC, NSCLC, OC, pancreatic adenocarcinoma, melanoma, CC, and synovial sarcoma. For the expansion phase: TNBC, CRC, CC and OC. Agrees to provide a newly obtained biopsy of an accessible lesion (if they can be biopsied based on the investigator's assessment) prior to the start of study treatment, and to repeat biopsy once during study treatment. Tissue obtained for the biopsy must not be previously irradiated (unless progressing following irradiation), but a new or progressing lesion in the radiation field is acceptable. Able to provide an archival tumor tissue sample for central lab analysis. This is required for subjects unable to undergo biopsy and must be requested for all others. In the investigator's opinion, the subject may not derive clinical benefit from, or is ineligible for, a particular form of standard therapy on medical grounds, or the subject failed or did not tolerate one or more of other anti-cancer therapies: a. For the dose escalation/regimen exploration phase: i. Refractory, intolerant, or refused all available standard-of-care therapies ii. Up to 3 previous lines of systemic anticancer therapies for metastatic disease are allowed. iii. Patients with TNBC or OC with known BRCA mutations must have been previously treated with or intolerant to FDA approved treatments prior to enrolling in this study (e.g. iPARP). iv. Patients with OC must have been treated with, refused, or were ineligible for treatment with bevacizumab to enroll. v. Patients with CRC tumors that are MSI-H/dMMR must have received, refused or be intolerant to a check point inhibitor. b. For the expansion phase: i. TNBC must have progressed after prior 1-3 systemic therapies. Patients must have refused or be intolerant to the FDA approved treatments for recurrent TNBC (e.g., iPARP). Patients who are PD-L1 positive should have received, refused or intolerant to pembrolizumab. ii. CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of 3 prior lines of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF, anti-EGFR targeted agents (as indicated). Patients with MSI-H/dMMR must have received, refused or be intolerant to a check point inhibitor. iii. CC that has recurred or progressed after 1-2 standard treatment regimens. This must include cisplatin and gemcitabine-based therapy (unless a patient refused or was ineligible for treatment). iv. OC that has progressed after 1-3 lines of therapy including a taxane and an anthracycline or intolerant to these agents. Patients must have been treated with, refused, or were ineligible for treatment with bevacizumab to enroll. Patients with known BRCA mutations must have been previously treated with or intolerant to FDA approved treatments prior to enrolling in this study (e.g. iPARP). Evaluable disease per RECIST 1.1 with at least one target lesion. If not menopausal or surgically sterile, willing to practice at least one of the following highly effective methods of birth control for at least a (partner's) menstrual cycle before and for four months after ST316 administration. Exclusion Criteria: Known hypersensitivity to ST316 or any of its excipients. Corrected interval between Q and T wave on ECG (QTc) > 480 msec using Fredericia's formula. Symptomatic ascites or pleural effusion. A subject who is clinically stable for 4 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible. Known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks prior to study entry and have no evidence of new or enlarging brain metastases. Subjects with treated brain metastases must also follow the steroid exclusion criterion (#9) listed below. For expansion phase only: presence of any other active malignancy requiring systemic therapy other than the disease under study. Concurrent anti-cancer therapy. Known HIV and positive -

Sites / Locations

  • USC Norris Comprehensive Cancer CenterRecruiting
  • Sarah Cannon Research Institute - CORecruiting
  • START MidwestRecruiting
  • Duke UniverstiyRecruiting
  • Sanford Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation Phase

Triple Negative Breast Cancer - Expansion phase

Colon Rectal Cancer (CRC) Expansion phase

Cholangiocarcinoma - Expansion phase

Ovarian Carcinoma

Arm Description

The dose cohorts will be 0.5, 1, 2, 4, and 8 mg/kg IV once weekly (QW)

Triple Negative Breast Cancer Expansion phase n=30

Expansion phase n=30

cholangiocarcinoma Expansion phase n=30

Ovarian Carcinoma - Expansion phase n=30

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Secondary Outcome Measures

ST316 PK parameter AUCt
Area under the concentration-time curve over the dosing interval
ST316 Assessment DOR
DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier
ST316 PK parameter Cmax
Maximum observed serum concentration
ST316 PK parameter t1/2
half life
ST316 PK parameter AUCโˆž
Area under the concentration-time curve over the dosing interval time from time 0 extrapolated to infinite time
ST316 PK parameter tmax.
The time take to reach Maximum observed serum concentration
ST316 Assessment Overall survival (OS)
Overall survival (OS) is defined as time from first study treatment to death due to any cause.
ST316 Assessment Progression-free survival (PFS)
Progression-free survival (PFS) is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.
ST316 Assessment Objective Response Rate (ORR)
ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Full Information

First Posted
March 21, 2023
Last Updated
September 19, 2023
Sponsor
Sapience Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05848739
Brief Title
A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors
Official Title
A Phase 1-2 Dose-escalation and Expansion Study of ST316 in Subjects With Selected Advanced Unresectable and Metastatic Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sapience Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an open-label, two-part, phase 1-2 study designed to determine the safety, tolerability, PK, pharmacodynamics (PD), and proof-of-concept efficacy of ST316 administered IV in subjects with selected advanced solid tumors likely to harbor abnormalities of the WNT/ฮฒ-catenin signaling pathway. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Metastatic, Pancreatic Cancer, NSCLC, Metastatic, Synovial Sarcoma, Colon Cancer, Metastatic Colon Cancer, Melanoma Recurrent, Metastatic Skin Cancer, Melanoma Stage IV, Triple Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Cholangiocarcinoma, Ovarian Cancer, Metastatic Melanoma, Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation Phase
Arm Type
Experimental
Arm Description
The dose cohorts will be 0.5, 1, 2, 4, and 8 mg/kg IV once weekly (QW)
Arm Title
Triple Negative Breast Cancer - Expansion phase
Arm Type
Experimental
Arm Description
Triple Negative Breast Cancer Expansion phase n=30
Arm Title
Colon Rectal Cancer (CRC) Expansion phase
Arm Type
Experimental
Arm Description
Expansion phase n=30
Arm Title
Cholangiocarcinoma - Expansion phase
Arm Type
Experimental
Arm Description
cholangiocarcinoma Expansion phase n=30
Arm Title
Ovarian Carcinoma
Arm Type
Experimental
Arm Description
Ovarian Carcinoma - Expansion phase n=30
Intervention Type
Drug
Intervention Name(s)
ST316
Intervention Description
IV
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
3 years
Secondary Outcome Measure Information:
Title
ST316 PK parameter AUCt
Description
Area under the concentration-time curve over the dosing interval
Time Frame
3 years
Title
ST316 Assessment DOR
Description
DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier
Time Frame
3 years
Title
ST316 PK parameter Cmax
Description
Maximum observed serum concentration
Time Frame
3 years
Title
ST316 PK parameter t1/2
Description
half life
Time Frame
3 years
Title
ST316 PK parameter AUCโˆž
Description
Area under the concentration-time curve over the dosing interval time from time 0 extrapolated to infinite time
Time Frame
3 years
Title
ST316 PK parameter tmax.
Description
The time take to reach Maximum observed serum concentration
Time Frame
3 years
Title
ST316 Assessment Overall survival (OS)
Description
Overall survival (OS) is defined as time from first study treatment to death due to any cause.
Time Frame
3 Years
Title
ST316 Assessment Progression-free survival (PFS)
Description
Progression-free survival (PFS) is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.
Time Frame
3 Years
Title
ST316 Assessment Objective Response Rate (ORR)
Description
ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time Frame
3 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able and willing to sign ICF and comply with the protocol and the restrictions and assessments therein. Male or female โ‰ฅ18 years of age. ECOG performance status 0-1. Must have a locally advanced or metastatic inoperable tumor as follows: For the dose escalation/regimen exploration phase: CRC, BC, NSCLC, OC, pancreatic adenocarcinoma, melanoma, CC, and synovial sarcoma. For the expansion phase: TNBC, CRC, CC and OC. Agrees to provide a newly obtained biopsy of an accessible lesion (if they can be biopsied based on the investigator's assessment) prior to the start of study treatment, and to repeat biopsy once during study treatment. Tissue obtained for the biopsy must not be previously irradiated (unless progressing following irradiation), but a new or progressing lesion in the radiation field is acceptable. Able to provide an archival tumor tissue sample for central lab analysis. This is required for subjects unable to undergo biopsy and must be requested for all others. In the investigator's opinion, the subject may not derive clinical benefit from, or is ineligible for, a particular form of standard therapy on medical grounds, or the subject failed or did not tolerate one or more of other anti-cancer therapies: a. For the dose escalation/regimen exploration phase: i. Refractory, intolerant, or refused all available standard-of-care therapies ii. Up to 3 previous lines of systemic anticancer therapies for metastatic disease are allowed. iii. Patients with TNBC or OC with known BRCA mutations must have been previously treated with or intolerant to FDA approved treatments prior to enrolling in this study (e.g. iPARP). iv. Patients with OC must have been treated with, refused, or were ineligible for treatment with bevacizumab to enroll. v. Patients with CRC tumors that are MSI-H/dMMR must have received, refused or be intolerant to a check point inhibitor. b. For the expansion phase: i. TNBC must have progressed after prior 1-3 systemic therapies. Patients must have refused or be intolerant to the FDA approved treatments for recurrent TNBC (e.g., iPARP). Patients who are PD-L1 positive should have received, refused or intolerant to pembrolizumab. ii. CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of 3 prior lines of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF, anti-EGFR targeted agents (as indicated). Patients with MSI-H/dMMR must have received, refused or be intolerant to a check point inhibitor. iii. CC that has recurred or progressed after 1-2 standard treatment regimens. This must include cisplatin and gemcitabine-based therapy (unless a patient refused or was ineligible for treatment). iv. OC that has progressed after 1-3 lines of therapy including a taxane and an anthracycline or intolerant to these agents. Patients must have been treated with, refused, or were ineligible for treatment with bevacizumab to enroll. Patients with known BRCA mutations must have been previously treated with or intolerant to FDA approved treatments prior to enrolling in this study (e.g. iPARP). Evaluable disease per RECIST 1.1 with at least one target lesion. If not menopausal or surgically sterile, willing to practice at least one of the following highly effective methods of birth control for at least a (partner's) menstrual cycle before and for four months after ST316 administration. Exclusion Criteria: Known hypersensitivity to ST316 or any of its excipients. Corrected interval between Q and T wave on ECG (QTc) > 480 msec using Fredericia's formula. Symptomatic ascites or pleural effusion. A subject who is clinically stable for 4 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible. Known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks prior to study entry and have no evidence of new or enlarging brain metastases. Subjects with treated brain metastases must also follow the steroid exclusion criterion (#9) listed below. For expansion phase only: presence of any other active malignancy requiring systemic therapy other than the disease under study. Concurrent anti-cancer therapy. Known HIV and positive -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Kaesshaefer
Phone
9737152917
Email
steve.kaesshaefer@bexonclinical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abi Vainstein-Haras
Organizational Affiliation
CMO
Official's Role
Study Chair
Facility Information:
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiomara Menendez, RN
Phone
323-865-0212
Email
Xiomara.Menendez@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Anthoney El-Khoueiry, MD
Facility Name
Sarah Cannon Research Institute - CO
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josh Henninger, MD
Email
Joshua.Henninger@SarahCannon.com
First Name & Middle Initial & Last Name & Degree
Jason Henry, MD
Facility Name
START Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Burns, BSN
Email
Julie.Burns@startmidwest.com
First Name & Middle Initial & Last Name & Degree
Nehal Lakhani, MD
Facility Name
Duke Universtiy
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JoAnna Gontarz, MSN
Email
joanna.gontarz@duke.edu
First Name & Middle Initial & Last Name & Degree
Niharika Mettu, MD PhD
Facility Name
Sanford Cancer Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Staci Vogel
Phone
605-312-3320
Email
staci.vogel@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Steven Powell, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors

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