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New treatment option for Solid Tumor
Official title STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas
ClinicalTrials.gov ID: NCT06975293
What this study is testing
What is STC-15 in combination with toripalimab?
STC-15 in combination with toripalimab is an investigational medicine, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely 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...
- 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...
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or the presence of ongoing pneumonitis/interstitial lung...
- Clinically significant cardiovascular disease or condition.
- Known active CNS metastases and/or leptomeningeal disease.
See the full eligibility 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. (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...
- Pre-treatment and on-treatment biopsy if medically feasible. Key
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Boston, Massachusetts, United States
- Lake Success, New York, United States
- Houston, Texas, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Boston, Massachusetts, United States; Lake Success, New York, United States; Houston, Texas, United States; Irving, Texas, United States; San Antonio, Texas, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.