A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors
A Phase 1-2 Dose-escalation and Expansion Study of ST316 in Subjects With Selected Advanced Unresectable and Metastatic Solid Tumors
1 other identifier
interventional
130
1 country
11
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/β-catenin signaling pathway. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2023
Longer than P75 for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2023
CompletedFirst Posted
Study publicly available on registry
May 8, 2023
CompletedStudy Start
First participant enrolled
June 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
May 11, 2025
May 1, 2025
3 years
March 21, 2023
May 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
3 years
Secondary Outcomes (9)
ST316 PK parameter AUCt
3 years
ST316 Assessment DOR
3 years
ST316 PK parameter Cmax
3 years
ST316 PK parameter t1/2
3 years
ST316 PK parameter AUC∞
3 years
- +4 more secondary outcomes
Study Arms (5)
Dose Escalation Phase
EXPERIMENTALThe dose cohorts will be 0.5, 1, 2, 4, 8 \& 12 mg/kg IV once weekly (QW)
ST316 Monotherapy Colon Rectal Cancer (CRC) Expansion phase
EXPERIMENTALST316 Monotherapy Colon Rectal Cancer (CRC) Expansion phase n=15-30
ST316 & FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phase
EXPERIMENTALST316 \& FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phase Expansion phase n=15-30
ST316 & Fruquintinib Combination CRC Expansion phase
EXPERIMENTALST316 \& Fruquintinib Combination CRC Expansion phase n=15-30
ST316 & Lonsurf + Bevacizumab Combination CRC Expansion phase
EXPERIMENTALST316 \& Lonsurf \& bevacizumab n=15-30
Interventions
IV
FOLFIRI: Days 1 and 15 of each 28-day cycle: * irinotecan 180 mg/m2 IV over 90 minutes concurrently with * leucovorin 400 mg/m2 IV over 2 hours, and then * 5-FU bolus 400mg/m2 (up to 15 min infusion) * 5-FU 2400 mg/m2 IV over 46 hours * bevacizumab should be administered as 5mg/kg.
5 mg once a day for the first 21 days of a 28-day cycle
Lonsurf 35 mg/m2 twice daily on days 1-5 and days 8-12 every 28 day bevacizumab 5 mg/kg on days 1 and 15. ST316
Eligibility Criteria
You may qualify if:
- Able and willing to sign an informed consent form (ICF) and comply with the protocol and the restrictions and assessments therein.
- Male or female ≥18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Must have a locally advanced or metastatic inoperable tumor as follows:
- For the dose-escalation phase: CRC, HCC, TNBC, NSCLC, OC, melanoma, CCA, and SS.
You may not qualify if:
- 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.
- 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:
- a. For the dose escalation phase: i. Refractory, intolerant, or refused available standard-of-care therapies. ii. Up to three previous lines of systemic anticancer therapies for metastatic disease are allowed (adjuvant or neoadjuvant setting do not count as lines of systemic therapy).
- iii. Subjects with TNBC or OC with known BRCA mutations must have been previously treated with or intolerant to Food and Drug Administration (FDA) approved treatments prior to enrolling in this study (e.g., iPARP).
- iv. Subjects with OC must have been treated with, refused, or were ineligible for treatment with bevacizumab to enroll.
- v. Subjects with CRC tumors that are MSI-H/dMMR must have received, refused or be intolerant to a checkpoint inhibitor (CPI).
- vi. Subjects with HCC must have confirmed diagnosis of inoperable hepatocellular carcinoma by histology or clinical/radiological criteria. No more than two prior lines of systemic therapy only and Child Pugh Score A or B7.
- b. For the expansion phase: i. For all cohorts: Subjects with MSI-H/dMMR must have received, refused or be intolerant to a CPI.
- ii. Cohort 1 ST316 monotherapy: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of four prior lines of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines, anti-vascular-endothelial growth factor (VEGF), anti-epidermal growth factor receptor (EGFR) targeted agents (as indicated).
- iii. Cohort 2: Combination with standard of care (SOC) FOLFIRI + bevacizumab: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of one prior line of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF. Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first line of treatment.
- iv. Cohort 3: Combination with fruquintinib: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of two prior lines of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines or anti-VEGF Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first or second line of treatment.
- v. Cohort 4: Combination with Lonsurf + beva: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of two prior lines of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines or anti-VEGF Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first or second line of treatment.
- Known hypersensitivity to ST316 or any of its excipients.
- 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.
- Corrected interval between Q and T wave on electrocardiogram (ECG) (QTc) \> 480 msec using Fredericia's formula.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of Alabama
Birmingham, Alabama, 35294, United States
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
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
START Midwest
Grand Rapids, Michigan, 49503, United States
Westchester Medical Center
Valhalla, New York, 10595, 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
Fred Hutch Cancer Center
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Abi Vainstein-Haras
CMO
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2023
First Posted
May 8, 2023
Study Start
June 5, 2023
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2027
Last Updated
May 11, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share