A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT03355066. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Open-Label, Dose-Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is an open-label, multi-center, dose-escalation, dose-finding and expansion study in adult subjects with advanced solid tumors for whom no standard therapy is available. The study will evaluate the safety, tolerability, PK, PD, and preliminary anti-tumor efficacy of SM08502 administered orally, once daily, following a 28-day treatment cycle (Part 1A). Alternative dosing schedules will be explored in Part 1B and the recommended Part 2 dose and schedule will be further evaluated in Part 2. Subjects will participate in a screening period of up to 14 days. Dosing in 28-day cycles will continue within each subject, unless treatment is discontinued due to toxicity, disease progression, initiation of a new anti-neoplastic therapy, withdrawal of consent, the Sponsor terminates the study, or the subject no longer meets retreatment criteria. Approximately 10 subjects enrolled in Part 2, irrespective of the tumor type, 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. Subjects participating in the food effect substudy will continue on study and complete assessments as per the Part 2 schedule and receive SM08502 at the recommended Part 2 dose (or another previously assessed dose level and schedule).
Study identification
- NCT ID
- NCT03355066
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 82 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 6, 2017 (Actual)
- Primary completion
- Nov 14, 2022 (Actual)
- Completion
- Nov 14, 2022 (Actual)
- Last update posted
- Aug 9, 2024
2017 – 2022
United States locations
- U.S. sites
- 19
- U.S. states
- 15
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Honor Health Research Institute | Scottsdale | Arizona | 85258 | — |
| University of Arizona Cancer Center | Tucson | Arizona | 85724 | — |
| City of Hope Medical Center | Duarte | California | 91010 | — |
| UC Davis - Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | 80218 | — |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | — |
| Northside Hospital | Atlanta | Georgia | 30342 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| START Midwest | Grand Rapids | Michigan | 49546 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Duke Cancer Institute | Durham | North Carolina | 27710 | — |
| Gabrail Cancer Center | Canton | Ohio | 44718 | — |
| University of Oklahoma Medicine Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Vanderbilt University | Nashville | Tennessee | 37232 | — |
| NEXT Oncology | San Antonio | Texas | 78229 | — |
| UT Health San Antonio - Mays Cancer Center | San Antonio | Texas | 78229 | — |
| START Mountain Region | West Valley City | Utah | 84119 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03355066, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2024 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03355066 live on ClinicalTrials.gov.