KZR-261 for Cancer

Recruiting at 11 trial locations

Overseen By Anthony Olszanski, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kezar Life Sciences, Inc.

Must not be taking: Cytotoxic, Biologic, Targeted therapies

Disqualifiers: CNS metastases, Pulmonary disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

61 Participants Needed

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.

Do I need to stop my current medications to join the trial?

The trial requires that you stop taking certain cancer treatments, such as cytotoxic, biologic, or targeted therapies, at least 14 days before starting the study drug. If you are on an investigational drug, you need to stop it 28 days before starting the trial.

Research Team

Kezar Study Director

Principal Investigator

Kezar Life Sciences, Inc.

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 (melanoma, colorectal, prostate, or mesothelioma) has been confirmed by lab tests.

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

My disease did not respond to or came back after standard treatment, or I refused such treatment.

Exclusion Criteria

Any female who is breastfeeding or who plans to become pregnant during the study, or who are actively trying to conceive at the time of signing of the informed consent form (ICF)

Subjects who have participated in Part 1 dose escalation are not eligible to enroll in Part 2 dose expansion

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive KZR-261 in a dose escalation and expansion format to evaluate safety, tolerability, and preliminary anti-tumor activity

24 weeks

3 doses in a 28-day cycle

Safety Follow-up

Participants are monitored for safety after the treatment period

4-6 weeks

Long-Term Follow-up

Participants are monitored for long-term safety and efficacy outcomes

12 months

Treatment Details

Interventions

• KZR-261

Trial Overview 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.

Participant Groups

Group I: KZR-261 with standard therapy: open-label Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Kezar Life Sciences, Inc.

Lead Sponsor

Trials

7

Recruited

280+