Oral Administration of STC-15 in Subjects With Advanced Malignancies

NCT05584111 | Completed Phase 1 FDA Drug

• 1 other identifier: STC15-22101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Advanced Cancer; Advanced Solid Tumor; Cancer

Keywords

Oncology; METTL-3 Inhibitor

Outcome Measures

Primary Outcomes (10)

• Number of participants with adverse events

  To evaluate the incidence, severity, and duration of adverse events

  Screening through end of treatment, approximately 6 months

• Cmax (PK)

  To determine the Cmax concentration over a dosing interval, systemic clearance, volume of distribution at steady-state (Vss), and accumulation ratio from first dose to steady-state.

  Screening through Cycle 2 (each cycle is 21 days)

• Tmax (PK)

  To determine the time to Cmax (Tmax)

  Screening through Cycle 2 (each cycle is 21 days)

• Ctrough (PK)

  To determine observed trough serum concentration (Ctrough)

  Screening through end of treatment, approximately 6 months

• Terminal elimination half life (PK)

  To determine the terminal elimination half-life (t½)

  Screening through Cycle 2 (each cycle is 21 days)

• AUC (PK)

  To determine AUC in 1 dosing interval

  Screening through Cycle 2 (each cycle is 21 days)

• Average concentration (PK)

  To determine the average concentration over a dosing interval

  Screening through Cycle 2 (each cycle is 21 days)

• Systemic Clearance (PK)

  To determine the systemic clearance

  Screening through Cycle 2 (each cycle is 21 days)

• Volume of distribution at steady-state (PK)

  To determine the volume of distribution at steady-state (Vss)

  Screening through Cycle 2 (each cycle is 21 days)

• Accumulation ratio from first dose to steady-state (PK)

  To determine the accumulation ratio from first dose to steady-state

  Screening through end of treatment, approximately 6 months

Secondary Outcomes (5)

• Efficacy as measured by RECIST 1.1 (DoR)

  Screening through disease progression, approximately 6 months

• Efficacy as measured by RECIST 1.1 (PFS)

  Screening through disease progression, approximately 6 months

• Efficacy as measured by RECIST 1.1 (DCR)

  Screening through disease progression, approximately 6 months

• Efficacy as measured by RECIST 1.1 (ORR)

  Screening through disease progression, approximately 6 months

• Recommended Phase 2 Dose (RP2D)

  Screening through 90 days after the last dose of STC-15, approximately 9 months

Other Outcomes (2)

• Assessment of m6A modification of mRNA from peripheral blood

  Screening through Cycle 2 (each cycle is 21 days)

• Assessment of serum cytokines levels

  Screening through Cycle 2 (each cycle is 21 days)

Study Arms (5)

Dose Level 1

EXPERIMENTAL

30mg capsules, daily administration for 3 week (21 day) cycles

Drug: STC-15

Dose Level 2

EXPERIMENTAL

30mg capsules, MWF administration for 3 week (21 day) cycles

Drug: STC-15

Dose Level 3

EXPERIMENTAL

100mg capsules, MWF administration for 3 week (21 day) cycles

Drug: STC-15

Dose Level 4

EXPERIMENTAL

30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles

Drug: STC-15

Dose Level 5

EXPERIMENTAL

30mg and 100mg capsules, M-MWF administration for 3 week (21 day) cycles

Drug: STC-15

Interventions

STC-15 DRUG

STC-15 oral capsules various dosing regimen in 3-week cycles

Also known as: METTL-3 Inhibitor

Dose Level 1; Dose Level 2; Dose Level 3; Dose Level 4; Dose Level 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years of age
• Histologic or cytologic confirmation of advanced malignancy that has failed standard of care (SOC) therapy and no further SOC therapy is available or the subject has declined additional SOC therapy
• Adequate organ and marrow function
• ECOG PS of 0 or 1

You may not qualify if:

• Treatment with any local or systemic antineoplastic therapy within 3 weeks prior to first dose of STC-15
• Major surgery or radiation within the 3 weeks
• Immune-related AEs from immunotherapy that required permanent discontinuation
• Central nervous system (CNS) disease involvement, or prior history of Grade ≥3 drug-related CNS toxicity.
• Active autoimmune disease that has required systemic treatment in the 2 years prior to Screening

Sponsors & Collaborators

• STORM Therapeutics LTD: lead

Study Sites (3)

Honor Health

Scottsdale, Arizona, 85258, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Josefin Holz

  STORM Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 18, 2022
• Study Start: November 15, 2022
• Primary Completion: August 30, 2024
• Study Completion: December 22, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)