TOS-358 for Cancer

Recruiting at 24 trial locations

Overseen By Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Totus Medicines

Must be taking: Fulvestrant

Must not be taking: PI3K inhibitors

Disqualifiers: Diabetes, Cushing syndrome, Heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

241 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests TOS-358, a new drug for adults with specific cancers that have a genetic mutation. It aims to find the safest dose and see how well patients tolerate it. The drug works by blocking a gene that helps cancer cells grow.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot have had recent systemic anticancer treatment before starting, except for breast cancer patients on fulvestrant. It's best to discuss your specific medications with the trial team.

Research Team

Zelanna Goldberg, MD

Principal Investigator

Totus Medicines

Eligibility Criteria

Adults over 18 with certain advanced solid tumors and specific genetic changes (PIK3CA mutations/amplifications) can join. They should have a life expectancy of at least 3 months, be able to consent, have measurable disease, good performance status (ECOG 0 or 1), and proper organ function. Excluded are those with diabetes, obesity (BMI ≥30), recent cancer treatments, heart issues within the past six months, prior PI3K pathway inhibitors use (except some breast cancer patients), other recent cancers or active brain metastases.

Inclusion Criteria

Willing and able to provide written informed consent for this study

I can provide a sample of my tumor for PIK3CA mutation testing.

My cancer has a PIK3CA mutation or amplification.

Exclusion Criteria

I haven't had cancer in the last 3 years, except for specific minor cases.

I have not taken drugs targeting the PI3K-AKT-mTOR pathway, except if I have breast cancer.

I haven't had cancer treatment before starting this trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding

TOS-358 is evaluated at multiple dose levels to determine the maximum tolerated dose and recommended phase 2 dose

Until disease progression or unacceptable toxicity

Dose Expansion

Evaluate safety and tolerability in tumor-specific cohorts at the recommended phase 2 dose

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TOS-358

Trial Overview TOS-358 is being tested for safety in adults with select solid tumors. The study will determine the highest dose patients can tolerate when taken orally once or twice daily without severe side effects and establish a recommended dose for future studies.

Participant Groups

Group I: TOS-358 Single Agent Arm Experimental Treatment 1 Intervention

Multiple doses of TOS-358 for oral administration.

Who Is Running the Clinical Trial?

Totus Medicines

Lead Sponsor

Trials

1

Recruited

240+