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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06975293
- Acronym / sponsor ID
- STC-15-24202
- Conditions
- Solid Tumor, Sarcoma, Leiomyosarcoma, Dedifferentiated Liposarcoma
- Keywords
- STC-15, Toripalimab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- STORM Therapeutics LTDIndustry (pharma, biotech, devices)
- Collaborators
- Coherus Oncology, Inc.
- Study start
- 5 May 2025 (actual)
- Primary completion
- 29 Dec 2027 (estimated)
- Study completion
- 29 Jun 2028 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 dose escalation | Experimental | Drug: STC-15 in combination with toripalimabPhase 1b 3+3 trial design of dose escalation of STC-15 in combination with toripalimab |
| Phase 2 Stage 1 Monotherapy | Experimental | Drug: STC-15 monotherapySTC-15 in patients with DD liposarcoma or leiomyosarcoma |
| Phase 2 Stage 2 Monotherapy | Experimental | Drug: STC-15 monotherapySTC-15 in patients with DD liposarcoma or leiomyosarcoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STC-15 in combination with toripalimabSTC-15 in combination with toripalimab in 21-day cycles | Drug | Phase 1 dose escalation |
| STC-15 monotherapySTC-15 monotherapy in 21-day cycles | Drug | Phase 2 Stage 1 Monotherapy, Phase 2 Stage 2 Monotherapy |
Primary outcome
Combination Cohorts: Safety and tolerability of STC-15 in combination with toripalimab
Time frame: 6 months
Incidence of adverse events graded according to CTCAE v5.0
Phase 2 Monotherapy Cohorts: Antitumor activity of STC-15 monotherapy
Time frame: 6 months
ORR according to RECIST
5 secondary outcomes
Combination Cohorts: Anti-tumor activity
Time frame: 6 months
Combination and Phase 2 Monotherapy Cohorts: Maximum observed plasma concentration of STC-15 (Cmax)
Time frame: 22 days
Combination and Phase 2 Monotherapy Cohorts: Calculated time to reach maximum observed plasma concentration (Tmax)
Time frame: 22 days
Combination and Phase 2 Monotherapy Cohorts: Calculated area under the plasma concentration-time curve of STC-15 (AUC0-t)
Time frame: 22 days
Phase 2 Monotherapy Cohorts: Safety and tolerability of STC-15
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandra Tong, MD study director
Storm Therapeutics
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Tong, MD (650-399-6357, sandy.tong@stormtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combination Cohorts: Safety and tolerability of STC-15 in combination with toripalimab (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.