TST003 for Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Suzhou Transcenta Therapeutics Co., Ltd.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests TST003, a new drug for treating advanced cancers. It focuses on patients with advanced or metastatic solid tumors and later specifically on colorectal cancer. The drug is given through a vein, and doctors will monitor its safety, side effects, and effectiveness.

Eligibility Criteria

Adults with certain advanced solid tumors, measurable lesions (for Phase Ib), and no standard treatment options left. They must be in good general health with proper organ function, not pregnant or nursing, and willing to use contraception. People who've had recent cancer treatments or severe illnesses are excluded.

Inclusion Criteria

I am 18 years old or older.

My cancer has worsened despite treatment and there are no standard treatments left.

My liver tests for bilirubin, ALT, and AST are within normal limits.

+13 more

Exclusion Criteria

I have brain metastases but haven't needed steroids for them in the last 4 weeks.

My heart's electrical activity (QT interval) is longer than normal or I have risk factors for irregular heartbeat.

I have had serious bleeding in my stomach or intestines in the last 3 months.

+22 more

Participant Groups

TST003 is being tested for safety in cancer patients. The study will determine the safe dosage level, how long it stays in the body, side effects experienced by participants, and if it helps shrink their tumors. It's given intravenously every three weeks as long as benefits continue.

2Treatment groups

Experimental Treatment

Group I: Phase 1b Part - Dose Expansion at Recommended Phase 2 doseExperimental Treatment1 Intervention

Administer TST003 every 3 weeks to patients with positive GREM1 tumor expression at the recommended Phase 2 Dose,

Group II: Phase 1a Part - TST003 Dose EscalationExperimental Treatment1 Intervention

TST003 administered every 3 weeks at increasing doses 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg