ST101 for Advanced Cancer

Recruiting at 10 trial locations

Overseen By Steve Kaesshaefer

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sapience Therapeutics

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Active infection, CNS metastases, others

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

Compensation: Varies

Number of Visits: Unknown

125 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, ST101, given to patients with advanced cancers who haven't responded to other treatments. The study aims to find the safest and most effective dose. It includes patients with specific types of breast cancer, melanoma, brain cancer, and prostate cancer.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before starting the study. Specifically, you must not use small molecule or tyrosine kinase inhibitors within 2 weeks or 5 half-lives before the first dose, and chemotherapy or biological cancer therapy within 3 weeks prior. If you're on systemic corticosteroids or immunosuppressive drugs, you need to stop them 15 to 30 days before starting the study, except for certain exceptions like inhaled or topical corticosteroids.

Research Team

Abi Vainstein-Haras, MD

Principal Investigator

CMO

Eligibility Criteria

Adults with advanced solid tumors, including glioblastoma and certain types of breast, prostate, and melanoma cancers. Participants must have a measurable disease that's progressed after previous treatments, be willing to use birth control if necessary, and able to provide biopsy samples. They should not have other active cancers or infections like hepatitis B/C or HIV, nor should they be on certain medications that could affect the trial.

Inclusion Criteria

I agree to have two biopsies: one before and one during the study.

All my side effects from cancer treatment have improved, except for hair loss.

My tumor cannot be removed by surgery and has spread.

Exclusion Criteria

I have HIV with a CD4+ T-cell count below 350.

Unable to comply with the visits and requirements of the protocol due to psychiatric condition or substance abuse

I have fluid buildup in my abdomen or around my lungs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

ST101 is administered intravenously in a dose-escalation phase to determine safety and tolerability. Dosing starts once per week with a 1-week observation period for safety assessment.

20 months

Weekly visits for dosing and observation

Dose Expansion

Participants are treated with the recommended phase 2 dose (RP2D) of ST101 in specific tumor-type cohorts to assess efficacy.

20 months

Regular visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

4 weeks

Treatment Details

Interventions

• ST101

Trial Overview The study is testing ST101 given intravenously alongside Temozolomide and Radiation in two phases: first to find the safest dose (Phase 1) and then to see how well it works at that dose (Phase 2). Researchers want to learn about its safety, how the body processes it, and its preliminary effectiveness against cancer.

Participant Groups

Group I: Newly Diagnosed Glioblastoma Experimental Treatment 3 Interventions

Newly diagnosed patients with a suboptimal resection or biopsy must be candidates for another surgical resection as determined by neurosurgical evaluation or multidisciplinary team based on the current standard of care that suggests that maximal safe resection is beneficial. Recurrent GBM patients must be candidates for tumor resection

Group II: Dose Expansion Recurrent Glioblastoma Experimental Treatment 1 Intervention

Recurrent GBM patients must have completed radiation at least 3 months prior to minimize the inclusion of patients with pseudoprogression. Recurrent GBM patients must have unequivocal radiographic evidence of tumor progression by contrast-enhanced magnetic resonance imaging (MRI) scan within 21 days prior to registration. Patients must be able to delay surgery for 2 - 4 weeks per investigator decision

Group III: Dose Expansion Melanoma Experimental Treatment 1 Intervention

This cohort must have Melanoma that has progressed after/or on treatment with an immune checkpoint inhibitor (CPI) and have received 1-2 prior lines of therapy for their advanced/metastatic disease. The starting dose of ST101 for Expansion will be derived from the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) and the best dosing schedule determined during Dose Escalation.

Group IV: Dose Expansion HR+ Breast Experimental Treatment 1 Intervention

This cohort must have progressed after 1-2 hormone based therapies. The starting dose of ST101 for Expansion will be derived from the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) and the best dosing schedule determined during Dose Escalation.

Group V: Dose Expansion GBM Experimental Treatment 1 Intervention

Primary (de novo) GBM that has recurred or progressed (per modified RANO criteria) after 1 standard treatment regimen. Standard therapy is defined as maximal surgical resection, radiotherapy, and concomitant temozolomide with radiotherapy or adjuvant chemotherapy with temozolomide. The starting dose of ST101 for Expansion will be derived from the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) and the best dosing schedule determined during Dose Escalation.

Group VI: Dose Expansion CRPC Experimental Treatment 1 Intervention

CRPC that has progressed after previous treatment with taxanes, abiraterone and enzalutamide/apalutamide. The starting dose of ST101 for Expansion will be derived from the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) and the best dosing schedule determined during Dose Escalation.

Group VII: Dose Escalation Experimental Treatment 1 Intervention

This cohort only patients diagnosed with locally advanced or metastatic melanoma, carcinoma or sarcoma of any tumor type who are refractory or intolerant to all available therapies. ST101 will be administered intravenously (IV), initially once per week.

Who Is Running the Clinical Trial?

Sapience Therapeutics

Lead Sponsor

Trials

2

Recruited

260+