NCT03355066

A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors

Terminated Phase 1 Last updated 9 August 2024

What this trial tests

Phase 1 trial testing SM08502 in Solid Tumor, Adult in 82 participants. Terminated before completion.

Timeline

6 November 2017

Primary endpoint
14 November 2022

14 November 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	82
Start date	6 November 2017
Primary completion	14 November 2022
Estimated completion	14 November 2022
Sites	19 locations across United States

Drugs / interventions tested

• SM08502 — full drug profile →

Conditions studied

• Solid Tumor, Adult — all drugs for Solid Tumor, Adult →

Sponsor

Biosplice Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Solid Tumor, Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

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

1. Wnt signaling in cancer: therapeutic targeting of Wnt signaling beyond β-catenin and the destruction complex.
   Jung YS, Park JI. · · 2020 · cited 335× · PMID 32037398 · DOI 10.1038/s12276-020-0380-6
2. WNT/β-Catenin Signaling Pathway Regulating T Cell-Inflammation in the Tumor Microenvironment.
   Li X, Xiang Y, Li F, Yin C, et al · · 2019 · cited 209× · PMID 31616443 · DOI 10.3389/fimmu.2019.02293
3. Alternative splicing and related RNA binding proteins in human health and disease.
   Tao Y, Zhang Q, Wang H, Yang X, et al · · 2024 · cited 190× · PMID 38302461 · DOI 10.1038/s41392-024-01734-2
4. The CLK inhibitor SM08502 induces anti-tumor activity and reduces Wnt pathway gene expression in gastrointestinal cancer models.
   Tam BY, Chiu K, Chung H, Bossard C, et al · · 2020 · cited 119× · PMID 31560935 · DOI 10.1016/j.canlet.2019.09.009
5. Harnessing big 'omics' data and AI for drug discovery in hepatocellular carcinoma.
   Chen B, Garmire L, Calvisi DF, Chua MS, et al · · 2020 · cited 109× · PMID 31900465 · DOI 10.1038/s41575-019-0240-9
6. Wnt Signaling in Cancer Metabolism and Immunity.
   El-Sahli S, Xie Y, Wang L, Liu S. · · 2019 · cited 96× · PMID 31261718 · DOI 10.3390/cancers11070904
7. Hypoxia-induced alternative splicing: the 11th Hallmark of Cancer.
   Farina AR, Cappabianca L, Sebastiano M, Zelli V, et al · · 2020 · cited 86× · PMID 32536347 · DOI 10.1186/s13046-020-01616-9
8. Wnt Signaling in Gynecologic Malignancies.
   McMellen A, Woodruff ER, Corr BR, Bitler BG, et al · · 2020 · cited 61× · PMID 32560059 · DOI 10.3390/ijms21124272