Oral Administration of STC-15 in Subjects With Advanced Malignancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2024-12-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Cancer Advanced Solid Tumor Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

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

Interventions

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STC-15

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

Intervention Type DRUG

Other Intervention Names

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METTL-3 Inhibitor

Eligibility Criteria

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Inclusion Criteria

* \> 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No