Trials / Terminated
TerminatedNCT05084859
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
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Biosplice Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SM08502 | SM08502 to be administered orally. |
| DRUG | Abiraterone | Abiraterone to be administered orally. |
| DRUG | Prednisone | Prednisone to be administered orally. |
| DRUG | Docetaxel | Docetaxel to be administered intravenously. |
| DRUG | FOLFIRI Protocol | FOLFIRI Protocol to be administered intravenously. |
| DRUG | Panitumumab | Panitumumab to be administered intravenously. |
Timeline
- Start date
- 2021-11-03
- Primary completion
- 2022-10-20
- Completion
- 2022-10-20
- First posted
- 2021-10-20
- Last updated
- 2024-08-09
Locations
20 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05084859. Inclusion in this directory is not an endorsement.