Serabelisib + Diet/Nab-paclitaxel for Solid Cancers

Recruiting in Palo Alto (17 mi)

+19 other locations

Overseen byVicky Makker

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Faeth Therapeutics

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new cancer drug called serabelisib with a special diet that lowers insulin levels, and sometimes with another drug called nab-paclitaxel. nab-Paclitaxel is used for treating triple-negative breast cancer. It targets cancer patients who suffer from severe side effects of current treatments. The goal is to block cancer growth pathways and lower insulin to reduce side effects and improve treatment effectiveness.

Eligibility Criteria

Adults with advanced solid tumors harboring PIK3CA mutations, who have tried and failed or were intolerant to a limited number of previous treatments. They must be able to consent, have a life expectancy over 3 months, adequate organ function, and no severe comorbidities. Women must not be pregnant and agree to use birth control; men must also agree to contraception.

Inclusion Criteria

I have had 3 or fewer chemotherapy treatments for ovarian cancer.

I have colorectal cancer and have had 2 or fewer treatments for it since it spread.

My cancer has come back and was confirmed by a lab test.

See 26 more

Exclusion Criteria

I have been treated with a PI3K inhibitor.

I had chemotherapy or radiation less than 3 weeks ago and still have significant side effects.

I have severe gout that isn't controlled by treatment.

See 30 more

Treatment Details

Interventions

Insulin Suppressing Diet (Behavioural Intervention)
Nab-paclitaxel (Taxane)
Serabelisib (PI3K inhibitor)

Trial OverviewThe trial is testing the combination of Serabelisib (a PI3K inhibitor) with an Insulin Suppressing Diet (ISD), both alone and alongside Nab-paclitaxel chemotherapy. The goal is to improve safety, reduce side effects, and enhance cancer-fighting efficacy in patients with specific genetic tumor profiles.

Participant Groups

5Treatment groups

Experimental Treatment

Group I: Cohort 4 - Expansion Ovarian Clear Cell or Ovarian Endometrioid CarcinomaExperimental Treatment3 Interventions

Subjects will receive dose of serabelisib as determined from Cohorts 1a and 1b, and will consume Insulin Suppressing Diet for up to 12 months. If results from Cohort 1b show a favorable risk-benefit ratio, nab-paclitaxel will be administered intravenously weekly.

Group II: Cohort 3 - Expansion Endometrial CancerExperimental Treatment3 Interventions

Subjects will receive dose of serabelisib as determined from Cohort 1a and 1b, and will consume Insulin Suppressing Diet for up to 12 months. If results from Cohort 1b show a favorable risk-benefit ratio, nab-paclitaxel will be administered intravenously weekly.

Group III: Cohort 2 - Expansion Colorectal CancerExperimental Treatment2 Interventions

Subjects will receive dose of serabelisib as determined from Cohort 1a and 1b, and will consume Insulin Suppressing Diet for up to 12 months

Group IV: Cohort 1b - Dose Modification with Nab-PaclitaxelExperimental Treatment3 Interventions

Subjects with endometrial cancer, ovarian clear cell or ovarian endometriod carcinoma will receive multiple doses of serabelisib administered orally and will consume Insulin Suppressing Diet for up to 12 months. In addition, these subjects will receive nab-paclitaxel intravenously weekly.

Group V: Cohort 1a - Dose Modification without nab-paclitaxelExperimental Treatment2 Interventions

Subjects with any solid tumor will receive multiple doses of serabelisib administered orally and will consume Insulin Suppressing Diet for up to 12 months