RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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/β-catenin signaling pathway. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.

Official Title

A Phase 1-2 Dose-escalation and Expansion Study of ST316 in Subjects With Selected Advanced Unresectable and Metastatic Solid Tumors

Quick Facts

Study Start:2023-06-05

Study Completion:2027-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05848739

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Able and willing to sign an informed consent form (ICF) and comply with the protocol and the restrictions and assessments therein. 2. Male or female ≥18 years of age. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 4. Must have a locally advanced or metastatic inoperable tumor as follows: 1. For the dose-escalation phase: CRC, HCC, TNBC, NSCLC, OC, melanoma, CCA, and SS. 2. For the expansion phase: CRC. Note: if additional indications and combinations are added inclusion/exclusion criteria will be updated. 5. 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, but a new or progressing lesion in the radiation field is acceptable. Subjects without accessible lesion for biopsy must be able to provide an archival tumor tissue sample for central lab analysis. 6. 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 anticancer therapies:	1. Known hypersensitivity to ST316 or any of its excipients. 2. Known hypersensitivity to bevacizumab, 5-FU, leucovorin or irinotecan for Cohort 2, to fruquintinib for Cohort 3 and trifluridine or tipiracil for Cohort 4 in the expansion. 3. Corrected interval between Q and T wave on electrocardiogram (ECG) (QTc) \> 480 msec using Fredericia's formula. 4. 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. 5. Known active central nervous system (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 (#11) listed below. 6. For expansion phase only: presence of any other active malignancy requiring systemic therapy other than the disease under study. 7. For subjects to be treated with a regimen containing bevacizumab: 1. History of cardiac disease: congestive heart failure (CHF) ≥NYHA Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring anti-arrhythmic therapy (βeta blockers or digoxin are permitted). 2. Current uncontrolled hypertension (systolic blood pressure \[BP\] \>150 mmHg or diastolic pressure \>90 mmHg despite optimal medical management) as well as prior history of hypertensive crisis or hypertensive encephalopathy. 3. History of arterial thrombotic or embolic events (within 6 months prior to study entry). 4. Significant vascular disease (e.g., aortic aneurysm, aortic dissection, symptomatic peripheral vascular disease). 5. Evidence of bleeding diathesis or clinically significant coagulopathy. 6. Major surgical procedure (including open biopsy, significant traumatic injury, etc.) within 28 days, or anticipation of the need for major surgical procedure during the course of the study as well as minor surgical procedure (excluding placement of a vascular access device or bone marrow biopsy) within 7 days prior to study enrollment. 7. Proteinuria at screening as demonstrated by urinalysis with proteinuria ≥2+ (subjects discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤1g of protein in 24 hours to be eligible). 8. History of abdominal fistula, gastrointestinal perforation, peptic ulcer, or intraabdominal abscess within 6 months. 9. Ongoing serious, non-healing wound, ulcer, or bone fracture. 10. History of reversible posterior leukoencephalopathy syndrome (RPLS). 11. History of hypersensitivity to Chinese hamster ovary (CHO) cells or other human or humanized recombinant antibodies.

Inclusion Criteria

Exclusion Criteria

1. Able and willing to sign an informed consent form (ICF) and comply with the protocol and the restrictions and assessments therein.
2. Male or female ≥18 years of age.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
4. Must have a locally advanced or metastatic inoperable tumor as follows:
1. For the dose-escalation phase: CRC, HCC, TNBC, NSCLC, OC, melanoma, CCA, and SS.
2. For the expansion phase: CRC. Note: if additional indications and combinations are added inclusion/exclusion criteria will be updated.
5. 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, but a new or progressing lesion in the radiation field is acceptable. Subjects without accessible lesion for biopsy must be able to provide an archival tumor tissue sample for central lab analysis.
6. 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 anticancer therapies:

1. Known hypersensitivity to ST316 or any of its excipients.
2. Known hypersensitivity to bevacizumab, 5-FU, leucovorin or irinotecan for Cohort 2, to fruquintinib for Cohort 3 and trifluridine or tipiracil for Cohort 4 in the expansion.
3. Corrected interval between Q and T wave on electrocardiogram (ECG) (QTc) \> 480 msec using Fredericia's formula.
4. 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.
5. Known active central nervous system (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 (#11) listed below.
6. For expansion phase only: presence of any other active malignancy requiring systemic therapy other than the disease under study.
7. For subjects to be treated with a regimen containing bevacizumab:
1. History of cardiac disease: congestive heart failure (CHF) ≥NYHA Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring anti-arrhythmic therapy (βeta blockers or digoxin are permitted).
2. Current uncontrolled hypertension (systolic blood pressure \[BP\] \>150 mmHg or diastolic pressure \>90 mmHg despite optimal medical management) as well as prior history of hypertensive crisis or hypertensive encephalopathy.
3. History of arterial thrombotic or embolic events (within 6 months prior to study entry).
4. Significant vascular disease (e.g., aortic aneurysm, aortic dissection, symptomatic peripheral vascular disease).
5. Evidence of bleeding diathesis or clinically significant coagulopathy.
6. Major surgical procedure (including open biopsy, significant traumatic injury, etc.) within 28 days, or anticipation of the need for major surgical procedure during the course of the study as well as minor surgical procedure (excluding placement of a vascular access device or bone marrow biopsy) within 7 days prior to study enrollment.
7. Proteinuria at screening as demonstrated by urinalysis with proteinuria ≥2+ (subjects discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤1g of protein in 24 hours to be eligible).
8. History of abdominal fistula, gastrointestinal perforation, peptic ulcer, or intraabdominal abscess within 6 months.
9. Ongoing serious, non-healing wound, ulcer, or bone fracture.
10. History of reversible posterior leukoencephalopathy syndrome (RPLS).
11. History of hypersensitivity to Chinese hamster ovary (CHO) cells or other human or humanized recombinant antibodies.

Contacts and Locations

Study Contact

Steve Kaesshaefer

CONTACT

9737152917

skaesshaefer@sapiencetherapeutics.com

Principal Investigator

Abi Vainstein-Haras

STUDY_CHAIR

CMO

Study Locations (Sites)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

Sarah Cannon Research Institute - CO

Denver, Colorado, 80218

United States

Ochsner Clinic Foundation

New Orleans, Louisiana, 70123

United States

START Midwest

Grand Rapids, Michigan, 49503

United States

Duke Universtiy

Durham, North Carolina, 27708

United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104

United States

Sanford Cancer Center

Sioux Falls, South Dakota, 57104

United States

Collaborators and Investigators

Sponsor: Sapience Therapeutics

Abi Vainstein-Haras, STUDY_CHAIR, CMO

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-05

Study Completion Date2027-05-31

Study Record Updates

Study Start Date2023-06-05

Study Completion Date2027-05-31

Terms related to this study

Additional Relevant MeSH Terms

Colon Cancer
Metastatic Colon Cancer