Dedifferentiated Liposarcoma, Leiomyosarcoma, Sarcoma, Solid Tumor
Conditions
Keywords
STC-15, Toripalimab, PD1, Checkpoint Combination
Brief 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).
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
Sponsors
STORM Therapeutics LTD
Coherus Oncology, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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. * Have adequate organ function. * Have the ability to swallow, retain, and absorb oral medication. Inclusion Criteria (Phase 2 Monotherapy Cohorts): * Have histologic or cytologic confirmation of advanced sarcoma of the selected histologic subtype that is not amenable to local curative therapy. Participant must have received at least 2, but no more than 4 prior lines of systemic therapy. * Pre-treatment and on-treatment biopsy if medically feasible. Key
Exclusion criteria
* 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). * Clinically significant cardiovascular disease or condition. * Known active CNS metastases and/or leptomeningeal disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combination Cohorts: Safety and tolerability of STC-15 in combination with toripalimab | 6 months | Incidence of adverse events graded according to CTCAE v5.0 |
| Phase 2 Monotherapy Cohorts: Antitumor activity of STC-15 monotherapy | 6 months | ORR according to RECIST |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combination Cohorts: Anti-tumor activity | 6 months | 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) | 22 days | — |
| Combination and Phase 2 Monotherapy Cohorts: Calculated time to reach maximum observed plasma concentration (Tmax) | 22 days | — |
| Combination and Phase 2 Monotherapy Cohorts: Calculated area under the plasma concentration-time curve of STC-15 (AUC0-t) | 22 days | — |
| Phase 2 Monotherapy Cohorts: Safety and tolerability of STC-15 | 6 months | Incidence of adverse events graded according to CTCAE v5.0 |
Countries
United States
Contacts
CONTACTSandra Tong, MD
CONTACTMelinda Snyder
STUDY_DIRECTORSandra Tong, MD
Storm Therapeutics
Outcome results
None listed