Dose Level 2 for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cancer+2 MoreSTC-15 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This Phase 1, multi-center, open-label, first-in-human study evaluates multiple ascending daily oral doses of STC-15 in Q3W treatment cycles in a 3+3 cohort design with dose levels determined by a modified Fibonacci algorithm. The study is designed to systematically assess safety and tolerability, pharmacokinetics, pharmacodynamics and clinical activity of STC-15 in adult subjects with advanced malignancies. Dose levels for further evaluation in expansion cohorts will be selected based on all available PK, pharmacodynamic, target engagement, efficacy, safety, and tolerability data including long-term safety data beyond dose limiting toxicities (DLTs). The study may be amended to evaluate STC-15 in combination with a Food and Drug Administration-approved standard of care treatment regimen, which could encompass targeted/chemotherapy, radiation therapy and/or immunotherapy with immune checkpoint blockers.

Eligible Conditions
  • Advanced Cancer
  • Advanced Solid Tumors
  • Cancer

Treatment Effectiveness

Study Objectives

10 Primary · 5 Secondary · Reporting Duration: Screening through end of treatment, approximately 6 months

Month 9
Recommended Phase 2 Dose (RP2D)
Day 21
AUC (PK)
Assessment of m6A modification of mRNA from peripheral blood
Cytokine
Average concentration (PK)
Cmax (PK)
Systemic Clearance (PK)
Terminal elimination half life (PK)
Tmax (PK)
Volume of distribution at steady-state (PK)
Month 6
Efficacy as measured by RECIST 1.1 (DCR)
Efficacy as measured by RECIST 1.1 (DoR)
Efficacy as measured by RECIST 1.1 (ORR)
Efficacy as measured by RECIST 1.1 (PFS)
Month 6
Accumulation ratio from first dose to steady-state (PK)
Ctrough (PK)
Number of participants with adverse events

Trial Safety

Trial Design

8 Treatment Groups

Dose Level 2
1 of 8
Dose Level 5
1 of 8
Dose Level 7
1 of 8
Dose Level 8
1 of 8
Dose Level 1
1 of 8
Dose Level 4
1 of 8
Dose Level 3
1 of 8
Dose Level 6
1 of 8

Experimental Treatment

66 Total Participants · 8 Treatment Groups

Primary Treatment: Dose Level 2 · No Placebo Group · Phase 1

Dose Level 2
Drug
Experimental Group · 1 Intervention: STC-15 · Intervention Types: Drug
Dose Level 5
Drug
Experimental Group · 1 Intervention: STC-15 · Intervention Types: Drug
Dose Level 7
Drug
Experimental Group · 1 Intervention: STC-15 · Intervention Types: Drug
Dose Level 8
Drug
Experimental Group · 1 Intervention: STC-15 · Intervention Types: Drug
Dose Level 1
Drug
Experimental Group · 1 Intervention: STC-15 · Intervention Types: Drug
Dose Level 4
Drug
Experimental Group · 1 Intervention: STC-15 · Intervention Types: Drug
Dose Level 3
Drug
Experimental Group · 1 Intervention: STC-15 · Intervention Types: Drug
Dose Level 6
Drug
Experimental Group · 1 Intervention: STC-15 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: screening through end of treatment, approximately 6 months

Who is running the clinical trial?

STORM Therapeutics LTDLead Sponsor
Josefin HolzStudy DirectorSTORM Therapeutics

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have no evidence of organ or marrow failure.