ST316 for Advanced Cancers
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Sapience Therapeutics
Must not be taking: Steroids, Anti-arrhythmics
Disqualifiers: CNS metastases, Cardiac disease, Hypertension, others
No Placebo Group
Breakthrough Therapy
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that participants should not have hypersensitivity to certain drugs used in the trial, like bevacizumab or irinotecan, which might imply some restrictions. It's best to discuss your current medications with the trial team.
What safety data exists for anticancer drugs in advanced cancer patients?
Anticancer drugs in advanced cancer patients have shown some benefits, but they also come with risks of severe side effects, including serious and fatal adverse events. Molecular target anticancer drugs, in particular, have been associated with an increased risk of serious and fatal adverse events compared to placebo.
12345Eligibility Criteria
Adults (≥18 years) with various advanced solid tumors that are inoperable or have spread, and who haven't benefited from standard treatments or can't tolerate them. Participants must be able to provide tumor tissue samples, practice effective birth control if applicable, and have a performance status indicating they are relatively active.Inclusion Criteria
I am 18 years old or older.
My doctor thinks standard treatments won't work for me or I've had bad reactions to cancer treatments.
I agree to have two biopsies: one before and one during the study.
+6 more
Exclusion Criteria
Your heart's electrical activity (ECG) shows a prolonged QT interval.
I am not currently receiving any cancer treatments.
You have been diagnosed with HIV.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
Phase 1 dose escalation/regimen exploration to determine safety, tolerability, PK, and PD of ST316
Varies by cohort
Expansion
Phase 2 expansion to evaluate proof-of-concept efficacy of ST316 in combination or monotherapy
3 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 years
Participant Groups
ST316 is being tested for safety and effectiveness against certain cancers likely affected by WNT/β-catenin pathway abnormalities. The trial has two parts: first to find the right dose of ST316, then to see how well it works at that dose.
5Treatment groups
Experimental Treatment
Group I: ST316 Monotherapy Colon Rectal Cancer (CRC) Expansion phaseExperimental Treatment1 Intervention
ST316 Monotherapy Colon Rectal Cancer (CRC) Expansion phase n=15-30
Group II: ST316 & Lonsurf + Bevacizumab Combination CRC Expansion phaseExperimental Treatment2 Interventions
ST316 \& Lonsurf \& bevacizumab n=15-30
Group III: ST316 & Fruquintinib Combination CRC Expansion phaseExperimental Treatment2 Interventions
ST316 \& Fruquintinib Combination CRC Expansion phase n=15-30
Group IV: ST316 & FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phaseExperimental Treatment2 Interventions
ST316 \& FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phase Expansion phase n=15-30
Group V: Dose Escalation PhaseExperimental Treatment1 Intervention
The dose cohorts will be 0.5, 1, 2, 4, 8 \& 12 mg/kg IV once weekly (QW)
ST316 is already approved in United States for the following indications:
🇺🇸 Approved in United States as ST316 for:
- Familial adenomatous polyposis (FAP) - Orphan Drug Designation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ochsner Clinic FoundationNew Orleans, LA
OU Health Stephenson Cancer CenterOklahoma City, OK
Duke UniverstiyDurham, NC
University of AlabamaBirmingham, AL
More Trial Locations
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Who Is Running the Clinical Trial?
Sapience TherapeuticsLead Sponsor
References
Risks and benefits of anticancer drugs in advanced cancer patients: A systematic review and meta-analysis. [2022]Background: Randomized clinical trials (RCTs) of anticancer drugs without active comparators in patients who have exhausted standard of care treatment options are debated. We aimed to quantify the safety and the efficacy of anticancer drugs in advanced cancer patients who have exhausted standard of care treatments from RCTs without active comparators.Methods: This systematic review and meta-analysis was conducted according to preferred reporting Items for systematic review and Meta-Analyses (PRISMA) guidelines (CRD42021243968). A systematic literature search of English language publications from January 1, 2000, to January 7, 2021, was performed using MEDLINE (PubMed). Eligible trials included all RCTs evaluating anticancer drugs in adult patients with advanced solid tumors with a control arm without any anticancer drug consisting of best supportive care with or without a placebo. RCTs performed in the adjuvant, neoadjuvant or maintenance settings were excluded, as were clinical trials evaluating anticancer drugs in combination with radiotherapy. Two authors (C.M.B. and E.C.) independently reviewed the studies for inclusion. Data from published reports were extracted by investigators, and random-effects meta-analysis was performed to estimate the overall hazard ratios (HRs) of progression-free survival (PFS) and overall survival (OS). Correlations between severe toxicity and efficacy was assessed using R2 measures.Findings: Of 3551 studies screened, 128 eligible trials were found involving 47,432 patients. The HRs for PFS and OS were 0·58 [95%CI: 0·53-0·63] and 0·82 [95%CI: 0·78-0·85]. The absolute benefits however were limited with PFS and OS gains of 2·1 and 0·5 months. The absolute excesses in all grade, severe grade III, IV and V (death) adverse events between the two arms were +13·9%, 10·2%, and +0·5%. A weak correlation was measured between the excess of severe toxicity and efficacy (all R² < 0·2).Interpretation: Anticancer drugs evaluated in RCTs against no active treatment benefited trial participants. Severe toxicity did not significantly correlate with efficacy.
Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis. [2020]Molecular target anticancer drugs are commonly used in various forms of cancers. It is a concern that the risk of serious adverse events (SAEs) and fatal adverse events (FAEs) of molecular target drugs are increasing. An up-to-date meta-analysis of all Phase II/III/IV randomized trials of molecular target anticancer drugs was conducted to calculate the increased risk of SAEs and FAEs. A systematic search of PubMed, Web of Science, and Cochrane Library up to April 6, 2017, was conducted. The study enrolled Phase II/III/IV randomized trials of cancer that compared molecular target drugs alone versus placebo or performed single-arm analysis of molecular target drugs. Data on SAEs and FAEs were extracted from the included studies and pooled to compute risk ratio (RR), the overall incidence, and 95% confidence interval (CI). In this meta-analysis, a total of 19,965 and 26,642 patients in randomized 53 and 65 Phase II/II/IV trials were included in the analysis of SAEs and FAEs associated with molecular target anticancer drug, respectively. There were significant differences in the relationship of molecular target anticancer drugs with SAEs (RR = 1.57, 95% CI = 1.35-1.82, P < 0.01, I2 = 81%) and FAEs (RR = 1.51, 95% CI = 1.19-1.91, P < 0.01, I2 = 0%) compared to placebo. The overall incidence of SAEs and FAEs was 0.269 (95% CI = 0.262-0.276, P < 0.01) and 0.023 (95% CI = 0.020-0.025, P < 0.01), respectively. Molecular target anticancer drugs significantly increased the risk of SAEs and FAEs. For patients taking molecular target drugs, efforts are needed to prevent the occurrence of SAEs and FAEs.
Systematic literature review of efficacy and safety of first-line maintenance therapy trials in advanced ovarian cancer. [2022]Aim: To review safety and efficacy outcomes in studies of first-line maintenance therapies for advanced ovarian cancer. Methods: A systematic literature review was performed (27 February 2020) to identify clinical outcomes including progression-free survival (PFS), overall survival (OS) and Grade ≥3 adverse events. Results: Overall 50 references met prespecified criteria; 18 studies evaluated 10 different agents, including PARP inhibitors. PFS was an end point in 16 trials and OS in 12 trials. PARP inhibitors reported better PFS hazard ratios (HRs: 0.59-0.68) compared with other classes; no mature OS data were identified. Safety reporting was inconsistent. Conclusion: Reported PFS HRs were better for PARP inhibitors than for other ovarian cancer maintenance therapies; overall survival data remain immature.
[Efficacy and safety of sunitinib on patients with imatinib-resistant gastrointestinal stromal tumor]. [2022]To investigate the efficacy and safety of sunitinib on the management of gastrointestinal stromal tumors (GIST) patients with imatinib resistance.
Safety, efficacy and prognostic analyses of sunitinib in the post-marketing surveillance study of Japanese patients with gastrointestinal stromal tumor. [2022]This study was conducted to expand the sunitinib safety database in Japanese imatinib-resistant/-intolerant gastrointestinal stromal tumor patients. Retrospective analyses investigated common adverse events as potential prognostic markers.