STC-15 + Toripalimab for Advanced Cancers

Recruiting at 2 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 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 four different locally advanced unresectable or metastatic tumors such as indications: (1) in combination with toripalimab (anti- programmed cell death 1 \[PD-1\]) in locally advanced and unresectable or metastatic non-small cell lung cancer (NSCLC), (2) in combination with toripalimab in locally advanced unresectable or metastatic melanoma, (3) in combination with toripalimab in locally advanced unresectable or metastatic endometrial cancers, and (4) in combination with toripalimab in locally advanced or metastatic head and neck squamous cell carcinoma (HNSCC). This study comprises of 2 parts: a combination dose escalation part (Phase 1b) followed by an assessment of the combination treatment's antitumor activity (Phase 2). This study will be conducted in adult participants with advanced malignancies to characterize the safety, tolerability, PK, and clinical activity of STC-15 in combination with toripalimab.

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.

I have endometrial cancer, treated with no more than 3 treatments, and it worsened after anti-PD-1/L1 therapy.

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+