KZR-261 for Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Kezar Life Sciences, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called KZR-261 to see if it is safe and effective for patients with advanced cancers that haven't responded to other treatments. The study will look at how the drug moves through the body and its effects on tumors.

Eligibility Criteria

This trial is for adults with advanced solid tumors that haven't responded to standard treatments, or where no standard treatment exists. Participants must be willing to use contraception and have a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory. They can't join if they've had recent cancer therapy, surgery, radiation, are pregnant/breastfeeding, have heart rhythm risks, uncontrolled lung disease, or CNS malignancies.

Inclusion Criteria

My cancer has spread or can't be removed by surgery and isn't primarily in the brain.

I am fully active or can carry out light work.

Exclusion Criteria

I have a serious lung condition that is not under control.

I have not had major surgery within the last 28 days.

I have not had radiation therapy in the last 14 days.

I have active brain cancer or cancer that has spread to my brain.

I have risk factors for a rare heart rhythm condition.

I still have side effects from cancer treatment (not including hair loss).

Participant Groups

The study tests KZR-261's safety and effectiveness against various solid tumors including melanoma and colorectal cancer. It has two parts: Dose Escalation to find the safe dosage level and Dose Expansion to further evaluate this dose in specific cancers. The goal is also to determine the best Phase 2 dose.

1Treatment groups

Experimental Treatment

Group I: KZR-261 with standard therapy: open-labelExperimental Treatment1 Intervention

Part 1 (Dose Escalation) The initial dose cohort of the Dose Escalation will receive 1.8 mg/m2 of KZR-261. Subjects will receive 3 doses in a 28-day cycle. ___________________________________________ Part 2 (Dose Expansion) Following safety review of all Dose Escalation cohorts and determination of the maximum tolerated dose (MTD) or maximum administered dose (MAD), KZR-261 will be evaluated for safety and preliminary efficacy in 4 tumor-specific cohorts and 1 all-tumor cohort to determine the recommended phase 2 dose (RP2D). The 4 tumor-specific cohorts will include: * melanoma (including uveal melanoma) * colorectal cancer * prostate cancer * mesothelioma