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
Public ClinicalTrials.gov record NCT05084859. 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 1b, Open-Label, Dose-Escalation, Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy 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 expansion study in adult subjects with advanced solid tumors. The study will evaluate the safety, tolerability, PK, and preliminary anti-tumor efficacy of SM08502 administered orally (PO), once daily (QD), following a 5 days on 2 days off treatment schedule in combination with chemotherapy or hormonal therapy. Alternative dosing schedules may be explored in Part 1 if necessary. The recommended Part 2 dose and schedule for each combination will then be further evaluated in the Part 2 expansion. Dosing will occur in 21- or 28-day cycles (depending on the combination partner) and treatment with SM08502 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.
Study identification
- NCT ID
- NCT05084859
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 30 participants
Conditions and interventions
Interventions
- SM08502 Drug
- Abiraterone Drug
- Prednisone Drug
- Docetaxel Drug
- FOLFIRI Protocol Drug
- Panitumumab Drug
Drug
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 3, 2021 (Actual)
- Primary completion
- Oct 20, 2022 (Actual)
- Completion
- Oct 20, 2022 (Actual)
- Last update posted
- Aug 9, 2024
2021 – 2022
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Arizona Cancer Center (UACC) - North Campus | Tucson | Arizona | 85719-1478 | — |
| University of Colorado, Anschutz | Aurora | Colorado | 80045-2571 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Maine Center for Cancer Medicine | Scarborough | Maine | 04074-7172 | — |
| START Midwest | Grand Rapids | Michigan | 49546 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021-0005 | — |
| Duke Cancer Institute (DCI) - Duke Cancer Center | Durham | North Carolina | 27710-2000 | — |
| The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, LLC | Cincinnati | Ohio | 45219 | — |
| Vanderbilt University | Nashville | Tennessee | 37212 | — |
| Texas Oncology | Fort Worth | Texas | 76104 | — |
| Texas Oncology-San Antonio Northeast | San Antonio | Texas | 78217 | — |
| UT Health San Antonio - Mays Cancer Center - Institute for Drug Development | San Antonio | Texas | 78229 | — |
| START Mountain Region | West Valley City | Utah | 84119 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 20176 | — |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | — |
| Seattle Cancer Care Alliance (SCCA) | Seattle | Washington | 98109-1023 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05084859, 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 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05084859 live on ClinicalTrials.gov.