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 four different locally advanced unresectable or metastatic tumors such as indications: (1) in combination with toripalimab (anti- programmed cell death 1 \[PD-1\]) in locally advanced and unresectable or metastatic non-small cell lung cancer (NSCLC), (2) in combination with toripalimab in locally advanced unresectable or metastatic melanoma, (3) in combination with toripalimab in locally advanced unresectable or metastatic endometrial cancers, and (4) in combination with toripalimab in locally advanced or metastatic head and neck squamous cell carcinoma (HNSCC). This study comprises of 2 parts: a combination dose escalation part (Phase 1b) followed by an assessment of the combination treatment's antitumor activity (Phase 2). This study will be conducted in adult participants with advanced malignancies to characterize the safety, tolerability, PK, and clinical activity of STC-15 in combination with toripalimab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
STC-15 in combination with toripalimab in 21-day cycles
Northwell Health Cancer Institute
Lake Success, New York, United States
RECRUITINGThe START Center
San Antonio, Texas, United States
RECRUITINGNEXT Oncology
Fairfax, Virginia, United States
RECRUITINGSafety and tolerability of STC-15 in combination with toripalimab
Incidence of adverse events graded according to CTCAE v5.0
Time frame: 6 months
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
Maximum observed plasma concentration of STC-15 (Cmax)
Time frame: 22 days
Recommended Phase 2 Dose
Identification of a tolerable and safe dose for expansion cohorts based on dose limiting toxicities
Time frame: 6 months
Calculated time to reach maximum observed plasma concentration (Tmax)
Time frame: 22 days
Calculated area under the plasma concentration-time curve of STC-15 (AUC0-t)
Time frame: 22 days
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