STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers

Launched by STORM THERAPEUTICS LTD · May 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a new treatment called STC-15 when combined with toripalimab for patients with certain advanced cancers, including lung cancer, melanoma, endometrial cancer, and head-and-neck cancer. This is an early-stage study, which means researchers are working to understand how well these treatments work together and how safe they are for patients with these types of cancer.

To be eligible for this trial, participants must be adults with a life expectancy of at least three months and specific types of cancer that have not responded to prior treatments. The study is looking for patients who have measurable disease and are able to take oral medications. Participants can expect to receive the new treatment and will be closely monitored for any side effects and how well the treatment works. It’s important to note that certain individuals, such as those who are pregnant or have specific health issues, may not qualify for the study. If you or a loved one is considering participation, it could offer access to a potentially helpful treatment option while contributing to important cancer research.

Gender

ALL

Eligibility criteria

• Key Inclusion 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 the ability to swallow, retain, and absorb oral medication.
• Inclusion Criteria (Expansion):
• • NSCLC (when applicable): Participants with AGAs (actionable genetic alterations) must have received targeted therapy unless contraindicated. Participants must not have received more than three previous lines of systemic treatment for unresectable locally advanced or metastatic disease. This must include at least a prior anti-PD-1/L1 alone or in combination with chemotherapy. Participants must have disease progression on prior anti-PD-1/L1.
• • HNSCC (when applicable): Participants must have progressed on following prior lines: 2L or 3L recurrent/metastatic disease; regardless of PD-L1 score. Participants must not have received more than three previous lines of systemic treatment for unresectable locally advanced or metastatic disease. This must include at least a prior anti-PD-1/L1 alone or in combination with chemotherapy.
• • Endometrial (when applicable): Participants must not have received more than three previous lines of systemic treatment for unresectable locally advanced or metastatic disease. This must include at least a prior anti-PD-1/L1 alone or in combination with chemotherapy. Participants must have disease progression on prior anti-PD-1/L1
• • Melanoma (when applicable): Participants must not have received more than three previous lines of systemic treatment for unresectable locally advanced or metastatic disease. This must include at least a prior anti-PD-1/L1 alone or in combination with chemotherapy. Participants must have disease progression on prior anti-PD-1/L1.
• Key Exclusion Criteria:
• • Pregnant and lactating women.
• • Received prior systemic anticancer therapy including investigational agents within 4 weeks 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.
• • Major surgery less than 4 weeks prior to the first IMP administration or participants who have not recovered from the side effects of the surgery.
• • 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.