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).
Estimated life expectancy ≥ 3 months.
ECOG performance status 0 or 1.
Measurable disease according to RECIST v1.1 as assessed by the local site investigator/radiology.
Documented radiologic assessment of progression on the prior therapy before study entry.
Pregnant and lactating women.
Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, prior to first IMP administration.
Participants who have not recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline, according to NCI-CTCAE v5.0. Exceptions include: alopecia, Grade ≤ 2 neuropathy, and endocrine-related AEs Grade ≤ 2 who are stable on treatment or hormone replacement.
History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or the presence of ongoing pneumonitis/interstitial lung disease).
Sequential
STC-15 in combination with toripalimab
DrugSTC-15 in combination with toripalimab in 21-day cycles
STC-15 monotherapy
DrugSTC-15 monotherapy in 21-day cycles
Combination Cohorts: Safety and tolerability of STC-15 in combination with toripalimab
Incidence of adverse events graded according to CTCAE v5.0
Phase 2 Monotherapy Cohorts: Antitumor activity of STC-15 monotherapy
ORR according to RECIST
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
Combination and Phase 2 Monotherapy Cohorts: Maximum observed plasma concentration of STC-15 (Cmax)
Combination and Phase 2 Monotherapy Cohorts: Calculated time to reach maximum observed plasma concentration (Tmax)
Combination and Phase 2 Monotherapy Cohorts: Calculated area under the plasma concentration-time curve of STC-15 (AUC0-t)
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STORM Therapeutics LTD
Lead sponsor
Coherus Oncology, Inc.
Collaborator
