Open-label, Non-randomized, Multi-cohort, Phase 1b/2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of STC-15 (a METTL3 Inhibitor) as a Part of Combination Therapy With Toripalimab in Participants With Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas
Summary
This early phase oncology trial will be conducted at various study centers to investigate the safety, tolerability, and antitumor activity of STC-15 (a METTL3 inhibitor) in combination with toripalimab (anti- programmed cell death 1 \[PD-1\]) in advanced unresectable or metastatic tumors. The Phase 2 Monotherapy part is an open-label, non-randomized, multicenter Simon's 2-stage design that investigates the safety, tolerability, and antitumor activity of STC-15 in participants with selected, relapsed sarcomas subtypes, dedifferentiated (DD) liposarcoma and leiomyosarcoma (uterine and non-uterine).
Arms & interventions
- Combination ProductSTC-15 in combination with toripalimab
STC-15 in combination with toripalimab in 21-day cycles
- DrugSTC-15 monotherapy
STC-15 monotherapy in 21-day cycles
Outcome measures
Primary
Combination Cohorts: Safety and tolerability of STC-15 in combination with toripalimab
Incidence of adverse events graded according to CTCAE v5.0
Time frame: 6 months
Phase 2 Monotherapy Cohorts: Antitumor activity of STC-15 monotherapy
ORR according to RECIST
Time frame: 6 months
Secondary
Combination Cohorts: Anti-tumor activity
Time frame: 6 months
Combination and Phase 2 Monotherapy Cohorts: Maximum observed plasma concentration of STC-15 (Cmax)
Time frame: 22 days
Combination and Phase 2 Monotherapy Cohorts: Calculated time to reach maximum observed plasma concentration (Tmax)
Time frame: 22 days
Combination and Phase 2 Monotherapy Cohorts: Calculated area under the plasma concentration-time curve of STC-15 (AUC0-t)
Time frame: 22 days
Phase 2 Monotherapy Cohorts: Safety and tolerability of STC-15
Time frame: 6 months
Eligibility criteria
Study locations (6)
Northwell Health Cancer Institute
Lake Success, New York, 11042
NEXT Houston
Houston, Texas, 77054
NEXT Dallas
Irving, Texas, 75039
NEXT Oncology
San Antonio, Texas, 78229
The START Center
San Antonio, Texas, 78229
NEXT Oncology
Fairfax, Virginia, 22031