CancerNCT07906093
Expanded Access Program to Provide STC-15 to Patients With Selected Advanced Cancer
A study testing STC-15 in people with Cancer, run by STORM Therapeutics LTD.
Trial summary
This Expanded Access Program (EAP) is intended to provide access to STC-15 outside of a clinical study setting for adult and pediatric patients with serious or life-threatening malignancies who, in the opinion of their treating physician, may benefit from treatment with STC-15, have no satisfactory alternative… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Cancer
- What is being tested?
- STC-15
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 1 year and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Adult patients aged ≥18 years, or pediatric patients aged ≥2 years with Sponsor medical approval, with a serious or life-threatening malignancy may be considered. Pediatric patients younger than 2 years, and in no case younger than 1 year, may be considered only on a case-by-case basis with explicit Sponsor approval when the treating physician and Sponsor agree that the potential benefit outweighs the increased uncertainty in this age group.
- Patient has histologically, cytologically, or hematopathologically confirmed malignancy.
- Disease is advanced, unresectable, metastatic, recurrent, relapsed/refractory, progressive, or otherwise not amenable to curative standard therapy.
- The patient has no satisfactory approved therapy available or appropriate in the treating physician's judgment, has progressive disease after standard therapy, is intolerant of standard therapy, is medically ineligible for standard therapy, has declined standard therapy after informed discussion, and/or is being considered for STC-15 as a bridge-to-transplant, bridge-to-local therapy, or disease-control strategy.
- Patient is not eligible for, cannot reasonably access, or cannot enroll in an ongoing STC-15 clinical trial within a clinically appropriate timeframe or a comparable investigational treatment.
- Combination of STC-15 with standard-of-care therapy is permitted only with prior Sponsor approval based on documented scientific and clinical rationale, assessment of overlapping toxicities, drug-interaction review, feasibility of safety monitoring, and confirmation that applicable regulatory and institutional requirements can be met.
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- Patient has active disease documented as applicable: recent imaging, marrow assessment, Minimal Residual Disease (MRD), circulating tumor/disease marker, biochemical marker, pathology/surgical assessment, clinical progression, or other disease-appropriate assessment. RECIST-measurable disease is preferred for solid tumors but is not required.
- At least one recent baseline disease assessment is available or planned before STC-15 initiation where feasible.
- Functional status is adequate to receive treatment and comply with treatment physician monitoring in the treating physician's and Sponsor's judgment.
- Patient has adequate hepatic, renal, and coagulation function for STC-15 use, or has disease-related abnormalities judged acceptable by Sponsor medical review.
- Patient can swallow, retain, and absorb oral STC-15, or has an acceptable enteral administration plan supported by Sponsor pharmacy/CMC review.
- Prior systemic anticancer therapy, investigational therapy, radiotherapy, or surgery has been followed by a clinically acceptable washout/recovery period, considering half-life, overlapping toxicity, urgency, and treating physician/Sponsor judgment. Clinically significant prior-therapy toxicities should have recovered to Grade ≤2, baseline, or a stable clinically acceptable status, unless Sponsor medical review determines the residual toxicity does not materially increase STC-15 risk.
- Medication list has been reviewed for CYP3A4 interactions, including azoles, macrolides, anticonvulsants, antibiotics, antivirals, herbal products, and other strong CYP3A4 inhibitors/inducers. Interacting medications must be discontinued, substituted, or specifically approved by Sponsor pharmacology/medical review.
- Women of childbearing potential must agree to use effective contraception during treatment with STC-15 and for at least 30 days after the last dose of STC-15, or longer if required by local regulations.
- Male patients with partners of childbearing potential must agree to use a condom during treatment with STC-15 and for at least 30 days after the last dose of STC-15, or longer if required by local regulations. Sperm donation is not allowed during treatment and for at least 30 days after the last dose of STC-15.
Who cannot join
- Patient is pregnant or breastfeeding or is unable or unwilling to comply with locally required contraception and pregnancy-prevention measures.
- Patient has uncontrolled infection, infection requiring parenteral antimicrobial therapy that is not clinically stabilized, uncontrolled sepsis risk, or other infection risk judged unacceptable by the treating physician or Sponsor.
- Patient has unstable cardiovascular disease, uncontrolled arrhythmia, symptomatic coronary disease, decompensated heart failure, uncontrolled hypertension, clinically significant pulmonary disease requiring recent hospitalization, uncontrolled seizure disorder, uncontrolled neurologic condition, or another serious uncontrolled illness that materially increases STC-15 risk in the opinion of the treating physician and the sponsor.
- Patient has active, symptomatic, or unstable Central Nervous System (CNS) metastases or leptomeningeal disease requiring escalating steroids, urgent local therapy, or otherwise making systemic treatment unsafe. Stable/treated CNS disease may be allowed.
- Patient has active clinically significant bleeding, a recent clinically significant bleeding event, an unstable platelet trajectory, or bleeding risk considered unacceptable by the treating physician or Sponsor.
- Patient has unresolved clinically significant toxicity from prior therapy that would materially increase STC-15 risk, as judged by the treating physician or Sponsor. Stable Grade ≤2 toxicities may be allowed.
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- Patient has prior METTL3 inhibitor exposure associated with documented intolerance, treatment-related serious toxicity, or clear progression without benefit. Prior STC-15 treatment may be allowed for continuation/rollover if clinical benefit and acceptable safety are documented.
- Patient has had major surgery within 30 days or radiotherapy within 14 days to STC-15 initiation such that unresolved toxicity, wound-healing risk, or overlapping toxicity is unacceptable, unless Sponsor approves the timing based on urgency and recovery status.
- Patient has clinically significant malabsorption, uncontrolled vomiting, bowel obstruction, or another condition expected to prevent reliable oral/enteral STC-15 exposure.
- Patient requires a strong CYP3A4 inhibitor or inducer that cannot be discontinued, substituted, or managed after Sponsor pharmacology/medical review.
- Any condition, laboratory abnormality, psychiatric/substance-use issue, logistical barrier, or site limitation that, in the judgment of the treating physician or Sponsor, would make STC-15 treatment inappropriate or prevent informed consent, reliable administration, safety reporting, or provision of data required for Sponsor oversight of patient safety and treatment use.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Expanded Access Program to Provide STC-15 to Adult and Pediatric Patients With Selected Advanced Malignancies
This Expanded Access Program (EAP) is intended to provide access to STC-15 outside of a clinical study setting for adult and pediatric patients with serious or life-threatening malignancies who, in the opinion of their treating physician, may benefit from treatment with STC-15, have no satisfactory alternative therapeutic options available, are not eligible for or cannot reasonably access an ongoing STC-15 clinical trial within a clinically appropriate timeframe, and meet the eligibility criteria described in this protocol. Pediatric patients may be considered only under the pediatric-specific requirements described in this protocol.
Read the detailed description
STC-15 will be administered orally to adults three times a week in continuous 21-day cycles. Medical assessments and safety monitoring will be performed in accordance with the EAP protocol and applicable institutional/local standard practice, with additional assessments at the treating physician's discretion.
- Conditions
- Cancer
- Being tested
- STC-15
- Keywords
- STC-15
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STC-15Drug
Also called METTL3 inhibitor
STC-15 will be administered orally to adults three times a week in continuous 21-day cycles. Pediatric dosing will be individualized based on age, weight/BSA, organ function, formulation/administration feasibility, and available clinical pharmacology data, and requires Sponsor medical approval.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- STORM Therapeutics LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Impatients N.V. trading as myTomorrows
- Responsible party
- Sponsor
- Investigators
- Glen Weiss, MD, Study director, STORM Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906093
- Sponsor's protocol ID
- STC15-26EAP
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program to Provide STC-15 to Adult and Pediatric Patients With Selected Advanced Malignancies
- ClinicalTrials.gov ID
- NCT07906093
- Acronym / sponsor ID
- STC15-26EAP
- Conditions
- Cancer
- Keywords
- STC-15
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- STORM Therapeutics LTDIndustry (pharma, biotech, devices)
- Collaborators
- Impatients N.V. trading as myTomorrows
- First posted
- 30 Oct 2026 (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 Expanded Access Program (EAP) is intended to provide access to STC-15 outside of a clinical study setting for adult and pediatric patients with serious or life-threatening malignancies who, in the opinion of their treating physician, may benefit from treatment with STC-15, have no satisfactory alternative therapeutic options available, are not eligible for or cannot reasonably access an ongoing STC-15 clinical trial within a clinically appropriate timeframe, and meet the eligibility criteria described in this protocol. Pediatric patients may be considered only under the pediatric-specific requirements described in this protocol.
Detailed description
STC-15 will be administered orally to adults three times a week in continuous 21-day cycles. Medical assessments and safety monitoring will be performed in accordance with the EAP protocol and applicable institutional/local standard practice, with additional assessments at the treating physician's discretion.
Study design
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Adult patients aged ≥18 years, or pediatric patients aged ≥2 years with Sponsor medical approval, with a serious or life-threatening malignancy may be considered. Pediatric patients younger than 2 years, and in no case younger than 1 year, may be considered only on a case-by-case basis with explicit Sponsor approval when the treating physician and Sponsor agree that the potential benefit outweighs the increased uncertainty in this age group.
- Patient has histologically, cytologically, or hematopathologically confirmed malignancy.
- Disease is advanced, unresectable, metastatic, recurrent, relapsed/refractory, progressive, or otherwise not amenable to curative standard therapy.
- The patient has no satisfactory approved therapy available or appropriate in the treating physician's judgment, has progressive disease after standard therapy, is intolerant of standard therapy, is medically ineligible for standard therapy, has declined standard therapy after informed discussion, and/or is being considered for STC-15 as a bridge-to-transplant, bridge-to-local therapy, or disease-control strategy.
- Patient is not eligible for, cannot reasonably access, or cannot enroll in an ongoing STC-15 clinical trial within a clinically appropriate timeframe or a comparable investigational treatment.
Key exclusion criteria (11 listed)
- Patient is pregnant or breastfeeding or is unable or unwilling to comply with locally required contraception and pregnancy-prevention measures.
- Patient has uncontrolled infection, infection requiring parenteral antimicrobial therapy that is not clinically stabilized, uncontrolled sepsis risk, or other infection risk judged unacceptable by the treating physician or Sponsor.
- Patient has unstable cardiovascular disease, uncontrolled arrhythmia, symptomatic coronary disease, decompensated heart failure, uncontrolled hypertension, clinically significant pulmonary disease requiring recent hospitalization, uncontrolled seizure disorder, uncontrolled neurologic condition, or another serious uncontrolled illness that materially increases STC-15 risk in the opinion of the treating physician and the sponsor.
- Patient has active, symptomatic, or unstable Central Nervous System (CNS) metastases or leptomeningeal disease requiring escalating steroids, urgent local therapy, or otherwise making systemic treatment unsafe. Stable/treated CNS disease may be allowed.
- Patient has active clinically significant bleeding, a recent clinically significant bleeding event, an unstable platelet trajectory, or bleeding risk considered unacceptable by the treating physician or Sponsor.
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-15Also: METTL3 inhibitorSTC-15 will be administered orally to adults three times a week in continuous 21-day cycles. Pediatric dosing will be individualized based on age, weight/BSA, organ function, formulation/administration feasibility, and available clinical pharmacology data, and requires Sponsor medical approval. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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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. This study is not recruiting at the moment.
Glen Weiss, MD study director
STORM Therapeutics
Questions about this trial
What is this clinical trial studying?
A study testing STC-15 in people with Cancer, run by STORM Therapeutics LTD.
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 15 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristen McCaleb, PhD (+44 1223 396012, kristen.mccaleb@stormtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 30 Oct 2026.