NCT04733521

A Phase 1/2 Study of SC-43 in Combination With Cisplatin

A Phase 1/2, Open-label, Study to Investigate the Safety, Tolerability, and Efficacy of SC-43 Administered in Combination With Cisplatin in Subjects With Advanced or Refractory Non-small Cell Lung Cancer or Biliary Tract Carcinoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: RaND Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

SC-43 is STAT3 inhibitor. Based on the phase I data of SC-43 monotherapy, this is a Phase 1/2, Open-label, Study to Investigate the Safety, Tolerability, and Efficacy of SC-43 Administered in Combination with Cisplatin in Subjects with Advanced or Refractory Non-small Cell Lung Cancer or Biliary Tract Carcinoma

Detailed description

Based on the ongoing Phase 1 study in refractory cancer types, it is deemed adequate to select the starting dose at 50 mg in combination with cisplatin for NSCLC or BTC. The safety monitoring committee (SMC) will review the starting dose of 50 mg data and decide whether it is adequate to escalate the dose to 100, then 150 mg according to Bayesian optimal interval (BOIN) design. Moreover, based on the PK profiles and modelling, the loading dose 100 mg QD for 7 days will keep the minimal efficacy concentration and effectively maintain the p-STAT3 level low enough to translate the anticancer efficacy with clinical efficacy for the study drug SC-43. The cisplatin efficacy for NSCLC and BTC, the chosen dose and dosing schedules 75 mg/m2 in a 3-week cycle in combination with SC-43 are supported by previous clinical experience of observed efficacy and safety profiles for the indicated study populations.

Conditions

• Advanced Non-small-cell Lung Cancer
• Advanced Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	SC-43	SC-43 oral, every day of 21-day cycle
DRUG	Cisplatin	cisplatin 75mg/m2 on day 1 of 21-day cycle

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2021-02-02
• Last updated: 2021-02-02

Regulatory

• FDA-regulated drug study