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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
107
STC-15 in combination with toripalimab in 21-day cycles
STC-15 monotherapy in 21-day cycles
Northwell Health Cancer Institute
Lake Success, New York, United States
RECRUITINGNEXT Houston
Houston, Texas, United States
RECRUITINGNEXT Dallas
Irving, Texas, United States
RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGThe START Center
San Antonio, Texas, United States
RECRUITINGNEXT Oncology
Fairfax, Virginia, United States
RECRUITINGCombination 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
Combination Cohorts: Anti-tumor activity
To evaluate the antitumor activity of STC-15 in combination with toripalimab as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST) criteria
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
Incidence of adverse events graded according to CTCAE v5.0
Time frame: 6 months
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