Solid TumorPhase 1/2NCT06975293
STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas
A Phase 1/2 study testing STC-15 in combination with toripalimab and STC-15 monotherapy in people with Solid Tumor and Sarcoma, run by STORM Therapeutics LTD at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Sarcoma, Leiomyosarcoma
- What is being tested?
- STC-15 in combination with toripalimab and STC-15 monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 14 sitesUnited States
- Study dates
- 5 May 2025to 29 Jun 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Andrew J Wagner, MD, PhD, 877-338-7425
Andrew J Wagner, MD, PhD
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Ankit Mangla, MD, 800-641-2422, CTUReferrals@UHhospitals.org
Ankit Mangla, MD
- Recruiting
NEXT Oncology
Fairfax, Virginia, 22031
Blake Patterson, 703-783-4505, bpatterson@nextoncology.com
M. Adham Salkeni, MD, FRCPC
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
Ronan Pleass, 616-954-5554, ronan.pleass@startresearch.com
Andrew Sochacki, MD
- Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Sarcoma Research Team, 713-792-3626, sarcomamedicaloncolo@mdanderson.org
Elise Nassif, MD
- Recruiting
NEXT Houston
Houston, Texas, 77054
Emma Morales, 832-384-7912, emorales@nextoncology.com
Jennifer Segar, MD
- Recruiting
NEXT Dallas
Irving, Texas, 75039
Aislyn Morales, 972-893-8800, amorales@nextoncology.com
Faran Polani, MD
- Recruiting
Northwell Health Cancer Institute
Lake Success, New York, 11042
Serena Petruzzelli, spetruzzelli@northwell.edu
Anthony Philip, MD
- Not yet recruiting
University of Miami-Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Nailet Real, 305-243-8173, nxr518@med.miami.edu
Emanuela Palmerini, M.D., Ph.D.
- Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Sareh Hogan, khoshis@mskcc.org
Olayode Babatunede, MD
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
Jordan Georg, 210-580-9521, jgeorg@nextoncology.com
Ildefonso I Rodriguez Rivera, MD
- Recruiting
The START Center
San Antonio, Texas, 78229
Isabel Jimenez, RN, MSN, 210-593-5265, isabel.jimenez@startresearch.com
Kyriakos Papadopoulos, MD
- Recruiting
University of California, San Francisco
San Francisco, California, 94158
Lisa Tan, 415-866-7866, Lisa.tan@ucsf.edu
Varun Monga, MBBS
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Vina Nguyen, nguyenvc@fredhutch.org
Lara E Davis, MD
About this study
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
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).
- Conditions
- Solid Tumor, Sarcoma, Leiomyosarcoma, Dedifferentiated Liposarcoma
- Being tested
- STC-15 in combination with toripalimab, STC-15 monotherapy
- Keywords
- STC-15, Toripalimab
- Medical subject headings
- Sarcoma, Leiomyosarcoma, Liposarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STC-15 in combination with toripalimabDrug
STC-15 in combination with toripalimab in 21-day cycles
STC-15 monotherapyDrug
STC-15 monotherapy in 21-day cycles
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 dose escalation | Experimental | Phase 1b 3+3 trial design of dose escalation of STC-15 in combination with toripalimab Receives: Drug: STC-15 in combination with toripalimab |
| Phase 2 Stage 1 Monotherapy | Experimental | STC-15 in patients with DD liposarcoma or leiomyosarcoma Receives: Drug: STC-15 monotherapy |
| Phase 2 Stage 2 Monotherapy | Experimental | STC-15 in patients with DD liposarcoma or leiomyosarcoma Receives: Drug: STC-15 monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combination Cohorts: Safety and tolerability of STC-15 in combination with toripalimab
Incidence of adverse events graded according to CTCAE v5.0
Measured: 6 months
Phase 2 Monotherapy Cohorts: Antitumor activity of STC-15 monotherapy
ORR according to RECIST
Measured: 6 months
Secondary outcomes (5)
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
Measured: 6 months
Combination and Phase 2 Monotherapy Cohorts: Maximum observed plasma concentration of STC-15 (Cmax)
Measured: 22 days
Combination and Phase 2 Monotherapy Cohorts: Calculated time to reach maximum observed plasma concentration (Tmax)
Measured: 22 days
Combination and Phase 2 Monotherapy Cohorts: Calculated area under the plasma concentration-time curve of STC-15 (AUC0-t)
Measured: 22 days
Phase 2 Monotherapy Cohorts: Safety and tolerability of STC-15
Incidence of adverse events graded according to CTCAE v5.0
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start5 May 2025
- Primary completion29 Dec 2027 (estimated)
- Study completion29 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- STORM Therapeutics LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Coherus Oncology, Inc.
- Responsible party
- Sponsor
- Investigators
- Sandra Tong, MD, Study director, Storm Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975293
- Sponsor's protocol ID
- STC-15-24202
- Status last verified
- Oct 2026
- First submitted
- 14 Apr 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided