SM08502 + Standard Treatments for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Biosplice Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called SM08502, taken by mouth, in adults with advanced solid tumors. The goal is to see if it helps other cancer treatments work better. The drug is taken for several days with short breaks in between.

Eligibility Criteria

Adults with advanced solid tumors like colorectal, lung, or prostate cancer can join this trial. They should be in good health otherwise, have a life expectancy over 3 months, and not have severe side effects from past treatments. Participants need to be able to take pills and agree to use birth control.

Inclusion Criteria

I do not have any untreated or uncontrolled health conditions.

I am fully active or can carry out light work.

I have advanced cancer confirmed by lab tests.

I can swallow and keep down pills.

Exclusion Criteria

I have brain metastasis that hasn't been treated or is getting worse.

I currently have an active infection.

I have had a heart attack in the last year, heart failure, or serious heart disease.

My heart's electrical cycle is longer than normal.

I am not pregnant or breastfeeding.

I have received an organ transplant.

I have a serious heart condition.

My liver is not working well (Child-Pugh B or C).

I have an active HIV, HBV, or HCV infection.

Participant Groups

The trial is testing SM08502 taken orally with standard hormonal therapy or chemotherapy for treating advanced cancers. It's an open-label study where everyone knows what treatment they're getting. The dose may change as the study goes on.

3Treatment groups

Experimental Treatment

Group I: NSCLC (Non-Small Cell Lung Cancer) - SM08502 + DocetaxelExperimental Treatment2 Interventions

Part 1 (dose escalation cohorts) will evaluate SM08502 in subjects with advanced NSCLC. Subjects will receive increasing doses of SM08502 with fixed doses of docetaxel to determine the MTD and recommended Part 2 dose and schedule. Escalation will follow a 3+3+3 design within each cohort. Part 2 will further evaluate the recommended dose and schedule of SM0850 in subjects with advanced NSCLC. Approximately 20 subjects will be enrolled.

Group II: CRPC (Castration Resistant Prostate Cancer) - SM08502 + Abiraterone/PrednisoneExperimental Treatment3 Interventions

Part 1 (dose escalation cohorts) will evaluate SM08502 in subjects with advanced CRPC. Subjects will receive increasing doses of SM08502 with fixed doses of Abiraterone/Prednisone to determine the MTD and recommended Part 2 dose and schedule. Escalation will follow a 3+3+3 design within each cohort. Part 2 will further evaluate the recommended dose and schedule of SM08502 in subjects with advanced CRPC. Approximately 20 subjects will be enrolled.

Group III: CRC (Colorectal Cancer) - SM08502 + FOLFIRI/PanitumumabExperimental Treatment3 Interventions

Part 1 (dose escalation cohorts) will evaluate SM08502 in subjects with advanced CRC. Subjects will receive increasing doses of SM08502 with fixed doses of FOLFIRI plus panitumumab ( RAS wild type tumors) or with fixed doses of FOLFIRI (RAS mutant tumors) Escalation will follow a 3+3+3 design within each cohort. Part 2 will further evaluate the recommended dose and schedule of SM08502. Subjects that have RAS wild type tumors will receive FOLFIRI and panitumumab with SM08502 (n=15). Subjects that have RAS mutant tumors will receive FOLFIRI with SM08502 (n=15).