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SM08502 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Biosplice Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have archived tumor specimens available for analysis or a fresh tumor biopsy will be required at study entry

Subjects with advanced solid tumors who are refractory to or intolerant of established therapy known to provide clinical benefit for their condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

Study Summary

This trial is testing a new drug for safety, tolerability, how it works in the body, and preliminary effectiveness against cancer in adults with advanced solid tumors for whom no standard therapy is available. Screening and dosing takes place over 28-day cycles, and the trial will assess different dosing schedules. A substudy will also test the effect of a high-fat, high-calorie meal on the drug's pharmacokinetics.

Who is the study for?

Adults with advanced solid tumors that have no standard treatment options can join. They must have measurable disease, be in good physical condition (ECOG ≤ 1), and have recovered from past treatments. A tumor sample for analysis is needed, and they shouldn't be pregnant or breastfeeding, nor should they have heart issues, severe liver problems, active infections requiring IV antibiotics, certain viral infections like HIV/HBV/HCV, or specific eye diseases.Check my eligibility

What is being tested?

The trial tests SM08502 taken orally by patients with advanced solid tumors to check its safety and how the body processes it. It's an open-label study where everyone knows what treatment they're getting. The drug is given daily in cycles of 28 days to see if it helps shrink the tumors.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical reactions to cancer medications such as nausea, fatigue, digestive issues due to oral administration affecting absorption or metabolism of the drug; also possible are changes in blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can provide a sample of my tumor for the study.

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My advanced cancer hasn't responded to or I can't tolerate standard treatments.

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I am fully active or have some restrictions but can still care for myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1A and Part 1B: AUC0-24 of SM08502 and SM08955 following single dose administration of SM08502

Part 1A and Part 1B: AUC0-24,ss of SM08502 and SM08955 following repeat dose administration of SM08502

Part 1A and Part 1B: AUClast of SM08502 and SM08955 following single dose administration of SM08502

+33 more

Secondary outcome measures

Part 1A and Part 1B: Tumor response as measured by RECIST 1.1 or PCWG3 criteria where appropriate

15S RNA

Part 2 Food Effect substudy: Cmax of SM08502 and SM08955 following single dose administration of SM08502 in fed and fasted states.

+11 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 2: ExpansionExperimental Treatment1 Intervention

Part 2 will evaluate the recommended Part 2 dose and schedule of SM08502, as determined in Part 1B, in 3 cohorts of subjects. The indications to be evaluated include subjects with advanced and/or metastatic CRPC (two biomarker selection cohorts) and NSCLC for which histologic or cytologic confirmation of malignancy was obtained at diagnosis. Each cohort will enroll up to 20 subjects. Approximately 10 subjects of the total enrolled in Part 2, irrespective of cohort, will be included in a food-effect substudy to assess the preliminary effect of a high-fat, high-calorie meal on the PK of SM08502.

Group II: Part 1B: Dose FindingExperimental Treatment1 Intervention

Indications eligible for Part 1B include castration-resistant prostate cancer (CRPC), non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), colorectal cancer (CRC), endometrial cancer, or ovarian cancer for which histologic or cytologic confirmation of malignancy was obtained at diagnosis. Initially, two cohorts of 6-24 subjects will be evaluated comparing 2 different doses and schedules of SM08502 (30 mg daily and 40 mg 5 days on and 2 days off), administered orally following 28-day treatment cycles. If appropriate, alternative doses and schedules may be evaluated depending on the results.

Group III: Part 1A: Dose EscalationExperimental Treatment1 Intervention

Cohorts of subjects with advanced solid tumors will receive increasing doses (10, 20, 40, 60, 80, 120, 160, or 200 mg) of SM08502, administered orally, once daily, following 28-day treatment cycles. If the maximum tolerated dose (MTD) is not determined at the 200 mg dose, dosing will continue at 50 mg/dose increments until an MTD is determined. Cohorts will include approximately 1 to 6 subjects according to an accelerated escalation design and safety requirements for expansion of subject numbers. For the purpose of dose escalation and de-escalation, the dose of SM08502 and regimen may be modified based on the type of dose limiting toxicities (DLTs) observed and following data review and discussions between the Sponsor and Investigators.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Biosplice Therapeutics, Inc.Lead Sponsor

21 Previous Clinical Trials

5,314 Total Patients Enrolled

Darrin Beaupre, MD, PhD, CMOStudy ChairBiosplice Therapeutics, Inc.

1 Previous Clinical Trials

30 Total Patients Enrolled

Media Library

SM08502 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03355066 — Phase 1

Solid Tumors Research Study Groups: Part 1A: Dose Escalation, Part 1B: Dose Finding, Part 2: Expansion

Solid Tumors Clinical Trial 2023: SM08502 Highlights & Side Effects. Trial Name: NCT03355066 — Phase 1

SM08502 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03355066 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has SM08502 been accorded regulatory authorization by the FDA?

"SM08502's safety is rated as a 1 because at this juncture, there is only limited clinical evidence confirming its efficacy and security."

Answered by AI

Are there any domestic sites conducting this research endeavor?

"Vanderbilt University Medical Center in Nashville, Sarah Cannon Research Institute at HealthONE in Denver and Gabrail Cancer Centre in Canton are some of the 21 sites running this clinical trial."

Answered by AI

Are any slots available for participation in this clinical experiment?

"According to clinicaltrials.gov, this medical trial is not actively enrolling patients at the moment; although it was initially posted on November 6th 2017 and last modified October 17th 2022, there are 2,425 other trials currently recruiting."

Answered by AI

Recent research and studies

Cancer LettersJournal

The CLK Inhibitor SM08502 Induces Anti-tumor Activity and Reduces Wnt Pathway Gene Expression in Gastrointestinal Cancer Models

Tam, Betty Y., Kevin Chiu, Heekyung Chung, Carine Bossard, John Duc Nguyen, Emily Creger, Brian W. Eastman, et al.. 2020. “The CLK Inhibitor SM08502 Induces Anti-tumor Activity and Reduces Wnt Pathway Gene Expression in Gastrointestinal Cancer Models”. Cancer Letters. Elsevier BV. doi:10.1016/j.canlet.2019.09.009.

ctnnb1Journal

Inhibiting Wnt/beta‐catenin in <i>ctnnb1</i> ‐mutated Endometrial Cancer

Moroney, Marisa R., Elizabeth Woodruff, Lubna Qamar, Andrew P. Bradford, Rebecca Wolsky, Benjamin G. Bitler, and Bradley R. Corr. 2021. “Inhibiting Wnt/beta‐catenin in ctnnb1 ‐mutated Endometrial Cancer”. Molecular Carcinogenesis. Wiley. doi:10.1002/mc.23308.

clinicaltrials.govStudy

A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors

2017. "A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03355066.