> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-1-2-of-st316-with-selected-advanced-unresectable-and-1dbc20cf-dddc-48b2-b2aa-d4ab894d053c > Record changed: 2026-11-04 # A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors NCT05848739 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) Participants 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) Lead sponsor Sapience Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) Start date 2023-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Short title** A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Official title** A Phase 1-2 Dose-escalation and Expansion Study of ST316 in Subjects With Selected Advanced Unresectable and Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) ## Dates **Completion date** 2027-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **First posted** 2023-05-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Registry last updated** 2026-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Primary completion date** 2026-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Start date** 2023-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) ## Size and sites **Participants** 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Planned participants** 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Lead sponsor** Sapience Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) ## Identifiers **Registry ID** NCT05848739 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **ClinicalTrials.gov ID** NCT05848739 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) ## Outcomes ### Primary outcomes 1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Timeframe: 3 years Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 ### Secondary outcomes 1. ST316 PK parameter AUCt Timeframe: 3 years Area under the concentration-time curve over the dosing interval 2. ST316 Assessment DOR Timeframe: 3 years 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 3. ST316 PK parameter Cmax Timeframe: 3 years Maximum observed serum concentration 4. ST316 PK parameter t1/2 Timeframe: 3 years half life 5. ST316 PK parameter AUC∞ Timeframe: 3 years Area under the concentration-time curve over the dosing interval time from time 0 extrapolated to infinite time 6. ST316 PK parameter tmax. Timeframe: 3 years The time take to reach Maximum observed serum concentration 7. ST316 Assessment Overall survival (OS) Timeframe: 3 Years Overall survival (OS) is defined as time from first study treatment to death due to any cause. 8. ST316 Assessment Progression-free survival (PFS) Timeframe: 3 Years 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. 9. ST316 Assessment Objective Response Rate (ORR) Timeframe: 3 Years 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion 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: 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. ### Exclusion criteria 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. \- Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) ## Sites - University of AlabamaBirmingham, United States - USC Norris Comprehensive Cancer CenterLos Angeles, United States - Sarah Cannon Research Institute - CODenver, United States - Ochsner Clinic FoundationNew Orleans, United States - Beth Israel Deaconess Medical CenterBoston, United States - START MidwestGrand Rapids, United States - Westchester Medical CenterValhalla, United States - Duke UniverstiyDurham, United States - OU Health Stephenson Cancer CenterOklahoma City, United States - Sanford Cancer CenterSioux Falls, United States - Fred Hutch Cancer CenterSeattle, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05848739) ## Related records ### Drugs (7) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Fruquintinib](https://trialight.com/data/asset/fruquintinib-e15c1522-cabe-4f7b-a918-3ca55e1ef88a.md) - [Irinotecan hydrochloride](https://trialight.com/data/asset/irinotecan-hydrochloride-c1f6b7df-7c76-40f1-92fe-12d71b1f3b25.md) - [Leucovorin calcium](https://trialight.com/data/asset/leucovorin-calcium-8da292ca-1b92-4365-b525-77d897b1c096.md) - [Tipiracil hydrochloride](https://trialight.com/data/asset/tipiracil-hydrochloride-c5072dfa-12fa-4ccc-9e35-c488a67c9673.md) - [Trifluridine](https://trialight.com/data/asset/trifluridine-cf1f965b-3efb-4c26-a766-cb4c7c73675f.md) ### Lead sponsors (1) - [Sapience Therapeutics](https://trialight.com/data/company/sapience-therapeutics-48a174a4-ef95-40a1-abc7-62c8b958a9ba.md) ### Conditions (2) - [Colonic neoplasm](https://trialight.com/data/condition/colonic-neoplasm-be61bc3a-c82f-5b84-a20f-3f9931cfcc77.md) - [Malignant colon neoplasm](https://trialight.com/data/condition/malignant-colon-neoplasm-8febeee7-0a8d-5f50-bffc-f2365535938e.md) Primary condition ### Targets (7) - [FLT1](https://trialight.com/data/target/flt1-2cfcec95-3fff-5be9-8423-701697547fa0.md) - [FLT4](https://trialight.com/data/target/flt4-c94058e2-ff1e-553b-92a5-8e7ee9305a80.md) - [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) - [TYMP](https://trialight.com/data/target/tymp-d3e9f860-719a-5bf3-88de-e36378c4ce8c.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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