Colon CancerPhase 1NCT05848739
A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors
A Phase 1 study testing ST316, FOLFIRI regimen & bevacizumab and Fruquintinib in people with Colon Cancer and Metastatic Colon Cancer, run by Sapience Therapeutics at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Metastatic Colon Cancer
- What is being tested?
- ST316, FOLFIRI regimen & bevacizumab and Fruquintinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 11 sitesUnited States
- Study dates
- 5 Jun 2023to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- For the expansion phase: CRC. Note: if additional indications and combinations are added inclusion/exclusion criteria will be updated.
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- 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:
- 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).
- 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).
- Subjects with OC must have been treated with, refused, or were ineligible for treatment with bevacizumab to enroll.
- Subjects with CRC tumors that are MSI-H/dMMR must have received, refused or be intolerant to a checkpoint inhibitor (CPI).
- 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.
- For the expansion phase: i. For all cohorts: Subjects with MSI-H/dMMR must have received, refused or be intolerant to a CPI.
- 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).
- 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.
- 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.
- 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.
Who cannot join
- 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.
- 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 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.
- For expansion phase only: presence of any other active malignancy requiring systemic therapy other than the disease under study.
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- For subjects to be treated with a regimen containing bevacizumab:
- 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).
- 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.
- History of arterial thrombotic or embolic events (within 6 months prior to study entry).
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection, symptomatic peripheral vascular disease).
- Evidence of bleeding diathesis or clinically significant coagulopathy.
- 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.
- 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).
- History of abdominal fistula, gastrointestinal perforation, peptic ulcer, or intraabdominal abscess within 6 months.
- Ongoing serious, non-healing wound, ulcer, or bone fracture.
- History of reversible posterior leukoencephalopathy syndrome (RPLS).
- History of hypersensitivity to Chinese hamster ovary (CHO) cells or other human or humanized recombinant antibodies.
- -
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Alabama
Birmingham, Alabama, 35294
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Sarah Cannon Research Institute - CO
Denver, Colorado, 80218
Duke Universtiy
Durham, North Carolina, 27708
START Midwest
Grand Rapids, Michigan, 49503
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Ochsner Clinic Foundation
New Orleans, Louisiana, 70123
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Fred Hutch Cancer Center
Seattle, Washington, 98109
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
Westchester Medical Center
Valhalla, New York, 10595
About this study
Official title: A Phase 1-2 Dose-escalation and Expansion Study of ST316 in Subjects With Selected Advanced Unresectable and Metastatic Solid Tumors
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.
- Conditions
- Colon Cancer, Metastatic Colon Cancer
- Being tested
- ST316, FOLFIRI regimen & bevacizumab, Fruquintinib, Lonsurf & bevacizumab
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST316Drug
IV
FOLFIRI regimen & bevacizumabDrug
Also called FOLFIRI
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.
FruquintinibDrug
5 mg once a day for the first 21 days of a 28-day cycle
Lonsurf & bevacizumabDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Phase | Experimental | The dose cohorts will be 0.5, 1, 2, 4, 8 \& 12 mg/kg IV once weekly (QW) Receives: Drug: ST316 |
| ST316 Monotherapy Colon Rectal Cancer (CRC) Expansion phase | Experimental | ST316 Monotherapy Colon Rectal Cancer (CRC) Expansion phase n=15-30 Receives: Drug: ST316 |
| ST316 & FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phase | Experimental | ST316 \& FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phase Expansion phase n=15-30 Receives: Drug: ST316; Drug: FOLFIRI regimen & bevacizumab |
| ST316 & Fruquintinib Combination CRC Expansion phase | Experimental | ST316 \& Fruquintinib Combination CRC Expansion phase n=15-30 Receives: Drug: ST316; Drug: Fruquintinib |
| ST316 & Lonsurf + Bevacizumab Combination CRC Expansion phase | Experimental | ST316 \& Lonsurf \& bevacizumab n=15-30 Receives: Drug: ST316; Drug: Lonsurf & bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (9)
ST316 PK parameter AUCt
Area under the concentration-time curve over the dosing interval
Measured: 3 years
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
Measured: 3 years
ST316 PK parameter Cmax
Maximum observed serum concentration
Measured: 3 years
ST316 PK parameter t1/2
half life
Measured: 3 years
ST316 PK parameter AUC∞
Area under the concentration-time curve over the dosing interval time from time 0 extrapolated to infinite time
Measured: 3 years
ST316 PK parameter tmax.
The time take to reach Maximum observed serum concentration
Measured: 3 years
ST316 Assessment Overall survival (OS)
Overall survival (OS) is defined as time from first study treatment to death due to any cause.
Measured: 3 Years
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.
Measured: 3 Years
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.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start5 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sapience Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abi Vainstein-Haras, Study chair, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848739
- Sponsor's protocol ID
- ST316-101
- Status last verified
- Jul 2026
- First submitted
- 21 Mar 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1-2 Dose-escalation and Expansion Study of ST316 in Subjects With Selected Advanced Unresectable and Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05848739
- Acronym / sponsor ID
- ST316-101
- Conditions
- Colon Cancer, Metastatic Colon Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Sapience TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Phase | Experimental | Drug: ST316The 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 | Experimental | Drug: ST316ST316 Monotherapy Colon Rectal Cancer (CRC) Expansion phase n=15-30 |
| ST316 & FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phase | Experimental | Drug: ST316, Drug: FOLFIRI regimen & bevacizumabST316 \& FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phase Expansion phase n=15-30 |
| ST316 & Fruquintinib Combination CRC Expansion phase | Experimental | Drug: ST316, Drug: FruquintinibST316 \& Fruquintinib Combination CRC Expansion phase n=15-30 |
| ST316 & Lonsurf + Bevacizumab Combination CRC Expansion phase | Experimental | Drug: ST316, Drug: Lonsurf & bevacizumabST316 \& Lonsurf \& bevacizumab n=15-30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- 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.
Key exclusion criteria (19 listed)
- 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.
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST316IV | Drug | Dose Escalation Phase, ST316 & FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phase, ST316 & Fruquintinib Combination CRC Expansion phase, ST316 & Lonsurf + Bevacizumab Combination CRC Expansion phase, ST316 Monotherapy Colon Rectal Cancer (CRC) Expansion phase |
| FOLFIRI regimen & bevacizumabAlso: FOLFIRIFOLFIRI: 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. | Drug | ST316 & FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phase |
| Fruquintinib5 mg once a day for the first 21 days of a 28-day cycle | Drug | ST316 & Fruquintinib Combination CRC Expansion phase |
| Lonsurf & bevacizumabLonsurf 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 | Drug | ST316 & Lonsurf + Bevacizumab Combination CRC Expansion phase |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
9 secondary outcomes
ST316 PK parameter AUCt
Time frame: 3 years
ST316 Assessment DOR
Time frame: 3 years
ST316 PK parameter Cmax
Time frame: 3 years
ST316 PK parameter t1/2
Time frame: 3 years
ST316 PK parameter AUC∞
Time frame: 3 years
ST316 PK parameter tmax.
Time frame: 3 years
ST316 Assessment Overall survival (OS)
Time frame: 3 Years
ST316 Assessment Progression-free survival (PFS)
Time frame: 3 Years
ST316 Assessment Objective Response Rate (ORR)
Time frame: 3 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abi Vainstein-Haras study chair
CMO
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ST316, FOLFIRI regimen & bevacizumab and Fruquintinib in people with Colon Cancer and Metastatic Colon Cancer, run by Sapience Therapeutics at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.