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SM08502 + Standard Treatments for Advanced 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 no uncontrolled intercurrent illness

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

Study Summary

This trial is testing a new drug, SM08502, for safety and effectiveness in treating advanced solid tumors, either alone or in combination with other cancer treatments.

Who is the study for?

Adults with advanced solid tumors like colorectal, lung, or prostate cancer can join this trial. They should be in good health otherwise, have a life expectancy over 3 months, and not have severe side effects from past treatments. Participants need to be able to take pills and agree to use birth control.Check my eligibility

What is being tested?

The trial is testing SM08502 taken orally with standard hormonal therapy or chemotherapy for treating advanced cancers. It's an open-label study where everyone knows what treatment they're getting. The dose may change as the study goes on.See study design

What are the potential side effects?

Possible side effects include those typical of chemotherapy such as nausea, fatigue, hair loss; hormonal therapy might cause hot flashes or mood swings; and SM08502 could potentially cause digestive issues or affect how other drugs work.

Eligibility Criteria

Inclusion Criteria

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

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I do not have any untreated or uncontrolled health conditions.

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I am fully active or can carry out light work.

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I have advanced cancer confirmed by lab tests.

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I can swallow and keep down pills.

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 1 - Blood samples for measurement of the plasma levels of SM08502 and its metabolite

Part 1 - Incidence of Treatment Emergent Adverse Events (TEAEs)

Part 1 - Maximum tolerated dose (MTD) of SM08502 when combined with standard of care agents.

+3 more

Secondary outcome measures

Part 1 - Objective Response rate

Part 2 - Blood samples for measurement of the plasma levels of SM08502 and its metabolite

Trial Design

3Treatment groups

Experimental Treatment

Group I: NSCLC (Non-Small Cell Lung Cancer) - SM08502 + DocetaxelExperimental Treatment2 Interventions

Part 1 (dose escalation cohorts) will evaluate SM08502 in subjects with advanced NSCLC. Subjects will receive increasing doses of SM08502 with fixed doses of docetaxel to determine the MTD and recommended Part 2 dose and schedule. Escalation will follow a 3+3+3 design within each cohort. Part 2 will further evaluate the recommended dose and schedule of SM0850 in subjects with advanced NSCLC. Approximately 20 subjects will be enrolled.

Group II: CRPC (Castration Resistant Prostate Cancer) - SM08502 + Abiraterone/PrednisoneExperimental Treatment3 Interventions

Part 1 (dose escalation cohorts) will evaluate SM08502 in subjects with advanced CRPC. Subjects will receive increasing doses of SM08502 with fixed doses of Abiraterone/Prednisone to determine the MTD and recommended Part 2 dose and schedule. Escalation will follow a 3+3+3 design within each cohort. Part 2 will further evaluate the recommended dose and schedule of SM08502 in subjects with advanced CRPC. Approximately 20 subjects will be enrolled.

Group III: CRC (Colorectal Cancer) - SM08502 + FOLFIRI/PanitumumabExperimental Treatment3 Interventions

Part 1 (dose escalation cohorts) will evaluate SM08502 in subjects with advanced CRC. Subjects will receive increasing doses of SM08502 with fixed doses of FOLFIRI plus panitumumab ( RAS wild type tumors) or with fixed doses of FOLFIRI (RAS mutant tumors) Escalation will follow a 3+3+3 design within each cohort. Part 2 will further evaluate the recommended dose and schedule of SM08502. Subjects that have RAS wild type tumors will receive FOLFIRI and panitumumab with SM08502 (n=15). Subjects that have RAS mutant tumors will receive FOLFIRI with SM08502 (n=15).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abiraterone

2012

Completed Phase 4

~2830

Docetaxel

1995

Completed Phase 4

~5620

Panitumumab

2020

Completed Phase 3

~6490

FOLFIRI Protocol

2014

Completed Phase 2

~50

Prednisone

2014

Completed Phase 4

~2370

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Biosplice Therapeutics, Inc.Lead Sponsor

21 Previous Clinical Trials

5,366 Total Patients Enrolled

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

1 Previous Clinical Trials

82 Total Patients Enrolled

Media Library

SM08502 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05084859 — Phase 1

Colorectal Cancer Research Study Groups: CRPC (Castration Resistant Prostate Cancer) - SM08502 + Abiraterone/Prednisone, NSCLC (Non-Small Cell Lung Cancer) - SM08502 + Docetaxel, CRC (Colorectal Cancer) - SM08502 + FOLFIRI/Panitumumab

Colorectal Cancer Clinical Trial 2023: SM08502 Highlights & Side Effects. Trial Name: NCT05084859 — Phase 1

SM08502 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05084859 — Phase 1

Frequently Asked Questions

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

What evidence is there of SM08502's safety for patients?

"The safety of SM08502 is deemed to be relatively low with a score of 1 due to the fact that this drug is still in its initial trial stages, thus there is limited evidence on both efficacy and safety."

Answered by AI

How many participants are being observed in this research project?

"At present, this clinical trial is not recruiting any more participants. The study was initially posted on November 3rd 2021 and last updated on October 18th 2022. If you seek out alternative studies, there are 2439 trials actively looking for patients with carcinoma or non-small-cell lung cancer and 1123 different investigations searching for SM08502 volunteers."

Answered by AI

How many healthcare facilities are conducting this research experiment?

"At the moment, 24 medical trial sites are recruiting patients for this study. These include UT Health San Antonio - Mays Cancer Center - Institute for Drug Development in San Antonio, Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office in Sarasota and University of California Los Angeles (UCLA) - Cancer Care-Santa Monica in Santa Monica as well as two dozen other locations."

Answered by AI

Are there currently any opportunities for volunteers to partake in this research?

"At this time, applications for this trial are not being accepted. This study was initially posted on the 3rd of November 2021 and last updated on 18th October 2022. If you're interested in other clinical trials, 2439 studies related to carcinoma non-small-cell lung cancer and 1123 dedicated to SM08502 are recruiting patients currently."

Answered by AI

Could you provide information on any prior experiments conducted with SM08502?

"Presently, there are 1123 research projects in progress delving into SM08502. Of these experiments, 333 have progressed to the Phase 3 stage. Shanghai is the primary location for studies related to this medication, yet 58701 sites around the world are running trials with it."

Answered by AI

For what medical ailments is SM08502 typically prescribed?

"SM08502 has been traditionally prescribed for thyroiditis yet it is also useful in treating ulcerative colitis, varicella-zoster virus acute retinal necrosis, and neurological diseases."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors

2021. "A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05084859.

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