What this study is
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).
What's being tested
- STC-15 in combination with toripalimab
Intervention · DRUG
STC-15 in combination with toripalimab in 21-day cycles
- STC-15 monotherapy
Intervention · DRUG
STC-15 monotherapy in 21-day cycles
Study details
- Official title
- 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
- Sponsor
- STORM Therapeutics LTD
- Conditions
- Solid Tumor · Sarcoma · Leiomyosarcoma · Dedifferentiated Liposarcoma
- Enrolling
- 107 people
- Starts
- 2025-05-05
- Est. completion
- 2028-06-29
- Design
- Open-label, non-randomized, sequential groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (14)
14 openUniversity of California, San Francisco
San Francisco, California, United States
- Lisa Tan · Contact415-866-7866Lisa.tan@ucsf.edu
- Varun Monga, MBBS · Principal investigator
RecruitingUniversity of Miami-Sylvester Comprehensive Cancer Center
Miami, Florida, United States
- Nailet Real · Contact305-243-8173nxr518@med.miami.edu
- Emanuela Palmerini, M.D., Ph.D. · Principal investigator
Not yet recruitingDana Farber Cancer Institute
Boston, Massachusetts, United States
- Andrew J Wagner, MD, PhD · Contact877-338-7425
- Andrew J Wagner, MD, PhD · Principal investigator
RecruitingSTART Midwest
Grand Rapids, Michigan, United States
- Ronan Pleass · Contact616-954-5554ronan.pleass@startresearch.com
- Andrew Sochacki, MD · Principal investigator
RecruitingNorthwell Health Cancer Institute
Lake Success, New York, United States
- Serena Petruzzelli · Contactspetruzzelli@northwell.edu
- Anthony Philip, MD · Principal investigator
RecruitingMemorial Sloan Kettering Cancer Center
New York, New York, United States
- Sareh Hogan · Contactkhoshis@mskcc.org
- Olayode Babatunede, MD · Principal investigator
Not yet recruitingUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
- Ankit Mangla, MD · Contact800-641-2422CTUReferrals@UHhospitals.org
- Ankit Mangla, MD · Principal investigator
RecruitingMD Anderson Cancer Center
Houston, Texas, United States
- Sarcoma Research Team · Contact713-792-3626sarcomamedicaloncolo@mdanderson.org
- Elise Nassif, MD · Principal investigator
Not yet recruitingNEXT Houston
Houston, Texas, United States
- Emma Morales · Contact832-384-7912emorales@nextoncology.com
- Jennifer Segar, MD · Principal investigator
RecruitingNEXT Dallas
Irving, Texas, United States
- Aislyn Morales · Contact972-893-8800amorales@nextoncology.com
- Faran Polani, MD · Principal investigator
RecruitingNEXT Oncology
San Antonio, Texas, United States
- Jordan Georg · Contact210-580-9521jgeorg@nextoncology.com
- Ildefonso I Rodriguez Rivera, MD · Principal investigator
RecruitingThe START Center
San Antonio, Texas, United States
- Isabel Jimenez, RN, MSN · Contact210-593-5265isabel.jimenez@startresearch.com
- Kyriakos Papadopoulos, MD · Principal investigator
RecruitingNEXT Oncology
Fairfax, Virginia, United States
- Blake Patterson · Contact703-783-4505bpatterson@nextoncology.com
- M. Adham Salkeni, MD, FRCPC · Principal investigator
RecruitingFred Hutchinson Cancer Center
Seattle, Washington, United States
- Vina Nguyen · Contactnguyenvc@fredhutch.org
- Lara E Davis, MD · Principal investigator
Recruiting
Study team
Sponsor
STORM Therapeutics LTD
Study ID STC-15-24202
Study director
Sandra Tong, MD
Storm Therapeutics
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.