Your session is about to expire
← Back to Search
Monoclonal Antibodies
KZR-261 for Cancer
Phase 1
Recruiting
Research Sponsored by Kezar Life Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologic or cytologic evidence of malignant solid tumor with advanced disease (except primary central nervous system [CNS] neoplasms), defined as cancer that is either metastatic or locally advanced and unresectable (and for which additional radiation therapy or other locoregional therapies are not considered to result in reasonable clinical benefit)
Eastern Cooperative Oncology Group Performance Status score of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 20 months
Awards & highlights
Study Summary
This trial is testing a new drug, KZR-261, to see if it is safe and effective against solid tumors. The study will also help determine the best dose of the drug to use.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects of KZR-261 may include typical reactions seen with anticancer drugs such as fatigue, nausea, diarrhea; blood count changes increasing infection risk; organ inflammation; allergic reactions; and possibly others based on its mechanism.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread or can't be removed by surgery and isn't primarily in the brain.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 20 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 20 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum plasma concentration of KZR-261 (Part 1)
Number and percentage of participants experiencing adverse events as assessed by CTCAE v5.0 (Part 1 & 2)
Number and percentage of participants experiencing dose-limiting toxicities as assessed by CTCAE v5.0 (Part 1)
+1 moreSecondary outcome measures
Duration of response (DOR) of KZR-261
Objective Response Rate (ORR) of KZR-261
Overall Survival of Patients treated with KZR-261
+1 moreTrial Design
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
Find a Location
Who is running the clinical trial?
Kezar Life Sciences, Inc.Lead Sponsor
6 Previous Clinical Trials
415 Total Patients Enrolled
Kezar Study DirectorStudy DirectorKezar Life Sciences, Inc.
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer (melanoma, colorectal, prostate, or mesothelioma) has been confirmed by lab tests.I have a serious lung condition that is not under control.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.My disease did not respond to or came back after standard treatment, or I refused such treatment.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 haven't had cancer treatment with drugs or targeted therapies in the last 14 days.My blood and organs are functioning well.I have risk factors for a rare heart rhythm condition.I am fully active or can carry out light work.I still have side effects from cancer treatment (not including hair loss).
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: KZR-261 with standard therapy: open-label
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the ultimate aim of this experiment?
"This clinical trial, spanning a period of around 20 months, will evaluate the Maximum plasma concentration of KZR-261 (Part 1) as its primary outcome. Secondary outcomes include the Objective Response Rate (ORR) according to RECIST v1.1, Progression-free Survival and Overall Survival timeframes for patients treated with KZR-261."
Answered by AI
Are there multiple healthcare facilities currently conducting this experiment within the state?
"There are 7 clinical trial centres taking part in this medical study. Locations include Virginia Cancer Specialists (VCS) in Fairfax, Moffitt Cancer Center in Tampa, and Winship Cancer Institute of Emory University in Atlanta - amongst other sites."
Answered by AI
What potential hazards are posed by KZR-261 ingestion?
"The safety of KZR-261 has been calculated to be a 1, as this is an initial trial with limited evidence concerning its efficacy and security."
Answered by AI
Is the enrollment phase of this trial ongoing?
"Affirmative. According to the information hosted on clinicaltrials.gov, this healthcare research project is currently enrolling participants. It was initially made available on September 30th 2021 and updated most recently on August 10th 2022; it requires 225 individuals from 7 distinct sites."
Answered by AI
What is the maximum allowable enrollment of this medical study?
"An estimated 225 individuals, meeting the necessary prerequisites, are needed to join this trial. Committed participants can take part at either Virginia Cancer Specialists (VCS) in Fairfax or Moffitt Cancer Center in Tampa."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
START (South Texas Accelerated Research Therapeutics)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger