NCT05084859

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

Terminated Phase 1 Last updated 9 August 2024

What this trial tests

Phase 1 trial testing SM08502 in Castration-resistant Prostate Cancer in 30 participants. Terminated before completion.

Timeline

3 November 2021

Primary endpoint
20 October 2022

20 October 2022

Quick facts

Lead sponsor	Biosplice Therapeutics, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	3 November 2021
Primary completion	20 October 2022
Estimated completion	20 October 2022
Sites	20 locations across United States, Australia

Drugs / interventions tested

• SM08502
• Abiraterone (ABIRATERONE) — full drug profile →
• Prednisone (prednisone) — full drug profile →
• Docetaxel (Docetaxel) — full drug profile →
• FOLFIRI Protocol — full drug profile →
• Panitumumab

Conditions studied

• Castration-resistant Prostate Cancer — all drugs for Castration-resistant Prostate Cancer →
• Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Biosplice Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Castration-resistant Prostate Cancer or Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Modulation of RNA splicing enhances response to BCL2 inhibition in leukemia.
   Wang E, Pineda JMB, Kim WJ, Chen S, et al · · 2023 · cited 58× · PMID 36563682 · DOI 10.1016/j.ccell.2022.12.002
2. Cdc2-like kinases: structure, biological function, and therapeutic targets for diseases.
   Song M, Pang L, Zhang M, Qu Y, et al · · 2023 · cited 40× · PMID 37029108 · DOI 10.1038/s41392-023-01409-4
3. A New Wave of Targeting 'Undruggable' Wnt Signaling for Cancer Therapy: Challenges and Opportunities.
   Park WJ, Kim MJ. · · 2023 · cited 34× · PMID 37190019 · DOI 10.3390/cells12081110
4. Targeting pre-mRNA splicing in cancers: roles, inhibitors, and therapeutic opportunities.
   Araki S, Ohori M, Yugami M. · · 2023 · cited 19× · PMID 37342192 · DOI 10.3389/fonc.2023.1152087
5. Targeting RNA splicing modulation: new perspectives for anticancer strategy?
   Lv X, Sun X, Gao Y, Song X, et al · · 2025 · cited 18× · PMID 39885614 · DOI 10.1186/s13046-025-03279-w
6. Why Is Wnt/β-Catenin Not Yet Targeted in Routine Cancer Care?
   de Pellegars-Malhortie A, Picque Lasorsa L, Mazard T, Granier F, et al · · 2024 · cited 12× · PMID 39065798 · DOI 10.3390/ph17070949
7. Targeting the CLK2/SRSF9 splicing axis in prostate cancer leads to decreased ARV7 expression.
   Van Goubergen J, Peřina M, Handle F, Morales E, et al · · 2025 · cited 4× · PMID 39258426 · DOI 10.1002/1878-0261.13728
8. RNA Epigenetics in Cancer: Current Knowledge and Therapeutic Implications.
   Huang S, Li Z, Lin W, Xie R, et al · · 2025 · cited 3× · PMID 40761481 · DOI 10.1002/mco2.70322