STC-15 + Toripalimab for Advanced Cancers

Recruiting at 3 trial locations

Overseen By Melinda Snyder

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: STORM Therapeutics LTD

Must be taking: Anti-PD-1/L1

Disqualifiers: Pregnancy, Recent surgery, Pneumonitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

188 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination treatment for certain advanced cancers, including lung, melanoma, endometrial, and head and neck cancers. The goal is to determine if the drugs STC-15 (a potential new drug) and toripalimab (an immunotherapy drug) are safe and effective when used together. The researchers seek individuals with these specific cancer types whose disease has progressed after previous treatments. Participants must be able to take oral medication and have a life expectancy of at least three months. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.

Will I have to stop taking my current medications?

The trial requires that you have not received any prior systemic anticancer therapy, including investigational agents, within 4 weeks before starting the study treatment. This means you may need to stop certain cancer medications before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of STC-15 and toripalimab was well tolerated in past studies. In an early study with STC-15, patients with advanced cancers managed the treatment without severe side effects. This suggests the treatment can be safely administered. Toripalimab, part of this combination, is already approved for use in certain cancers, further supporting its safety. However, this trial aims to confirm these findings and ensure the combination remains safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about STC-15 combined with toripalimab because unlike traditional chemotherapy and radiation treatments for advanced cancers, this combo targets the immune system. Toripalimab is an anti-PD-1 antibody, which helps the immune system recognize and attack cancer cells. When paired with STC-15, a novel compound whose mechanisms are still being explored, the combination has the potential to enhance immune response more effectively than existing options. This innovative approach could offer patients with advanced cancers, like NSCLC, melanoma, endometrial cancers, and HNSCC, a new hope by potentially boosting the body's natural defenses to fight cancer.

What evidence suggests that this trial's treatments could be effective for advanced cancers?

This trial will investigate the combination of STC-15 and toripalimab for treating advanced cancers. Research has shown that combining STC-15, which blocks pathways that aid cancer growth, and toripalimab, which helps the immune system target cancer cells, may be beneficial for advanced cancers. Studies have demonstrated that patients with certain genetic changes respond well to drugs like toripalimab. This combination aims to enhance the body's ability to fight cancer, particularly in non-small cell lung cancer, melanoma, endometrial cancer, and head and neck cancer. Although detailed human data remains limited, the mechanisms of these drugs suggest potential effectiveness against these cancers. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced cancers, including non-small cell lung cancer, melanoma, endometrial cancer, and head & neck squamous cell carcinoma. Participants must have tumors that are locally advanced, unresectable or metastatic.

Inclusion Criteria

Estimated life expectancy ≥ 3 months

I am fully active or can carry out light work.

My cancer can be measured by scans.

Exclusion Criteria

I haven't had cancer treatment or experimental drugs in the last 4 weeks.

I have had lung inflammation that needed steroids.

I am currently pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Phase 1b)

Combination dose escalation of STC-15 with toripalimab to determine safety and tolerability

6 months

Dose Expansion (Phase 2)

Assessment of antitumor activity of STC-15 with toripalimab in various cancer types

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STC-15
• Toripalimab

Trial Overview The trial is testing STC-15 (a METTL3 inhibitor) combined with toripalimab (an anti-PD-1 therapy). It's in early phases to see how safe it is and if it works against the cancer. The study has two parts: first finding the right doses and then checking its effect on tumors.

How Is the Trial Designed?

Group I: Dose expansion melanoma Experimental Treatment 1 Intervention

STC-15 in combination with toripalimab in locally advanced unresectable or metastatic melanoma

Group II: Dose expansion endometrial cancers Experimental Treatment 1 Intervention

STC-15 in combination with toripalimab in locally advanced unresectable or metastatic endometrial cancers

Group III: Dose expansion NSCLC Experimental Treatment 1 Intervention

STC-15 in combination with toripalimab (anti-PD-1) in locally advanced and unresectable or metastatic NSCLC

Group IV: Dose expansion HNSCC Experimental Treatment 1 Intervention

STC-15 in combination with toripalimab in locally advanced or metastatic HNSCC

Group V: Dose escalation Experimental Treatment 1 Intervention

Phase 1b 3+3 trial design of dose escalation of STC-15 in combination with toripalimab

Who Is Running the Clinical Trial?

STORM Therapeutics LTD

Lead Sponsor

Trials

1

Recruited

40+

Coherus Biosciences, Inc.

Industry Sponsor

Trials

19

Recruited

3,700+

Coherus Oncology, Inc.

Industry Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06975293

NCT06975293 | STC-15 as a Part of Combination Therapy ... This study will be conducted in adult participants with advanced malignancies to characterize the safety, tolerability, PK, and clinical activity of STC-15 in ...

2. investors.coherus.com investors.coherus.com/news-releases/news-release-details/coherus-announces-clinical-collaboration-storm-therapeutics

Coherus Announces Clinical Collaboration with STORM ... The phase 1b study will evaluate STC-15, a METTL3 inhibitor, in combination with LOQTORZI to determine the safety and efficacy of the combination.

3. withpower.com withpower.com/trial/stc-15-toripalimab-for-advanced-cancers-585f6

STC-15 + Toripalimab for Advanced Cancers This trial is for adults with certain advanced cancers, including non-small cell lung cancer, melanoma, endometrial cancer, and head & neck squamous cell ...

4. stocktitan.net stocktitan.net/news/CHRS/coherus-announces-clinical-collaboration-with-storm-therapeutics-to-xxpiwxdnmomm.html

Coherus Announces Clinical Collaboration with STORM ... The collaboration aims to evaluate the combination of STC-15 (METTL3 inhibitor) with LOQTORZI (toripalimab-tpzi) in a Phase 1b/2 study for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11366758/

A phase II clinical trial of toripalimab in advanced solid tumors ... Patients carrying mutations in polymerase epsilon/polymerase delta have shown positive responses to immune checkpoint inhibitors.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06975293

NCT06975293 | STC-15 as a Part of Combination Therapy ... This study will be conducted in adult participants with advanced malignancies to characterize the safety, tolerability, PK, and clinical activity of STC-15 in ...

7. stormtherapeutics.com stormtherapeutics.com/news/press-releases/storm-therapeutics-announces-first-patient-dosed-in-clinical-collaboration-to-evaluate-stc-15-in-combination-with-loqtorzi/

Press releases Final clinical results from a Phase 1 study of STC-15 in patients with advanced malignancies demonstrated that it is well tolerated and achieved ...

8. clinconnect.io clinconnect.io/trials/NCT06975293

STC-15 as a Part of Combination Therapy With Toripalimab 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 ...