KZR-261 in Subjects With Advanced Solid Malignancies | NCT05047536

NCT05047536

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KZR-261 with standard therapy: open-label	Experimental	Part 1 (Dose Escalation): The initial dose cohort of the Dose Escalation received 1.8 mg/m2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to 6 cycles. _________________ Part 2A (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 was to 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 castration-resistant prostate cancer mesothelioma Part 2B (Dose Optimization): Dose optimization in tumor-specific cohorts could have been initiated based on the totality of data after the MTD/MAD had been determined. Participants were to receive KZR-261 at the MTD/MAD or a lower clinically active dose of KZR-261.	Drug: KZR-261

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KZR-261	Drug	KZR-261 for Injection is a lyophilized drug product supplied in single-use vials delivering 75 mg of KZR-261.	KZR-261 with standard therapy: open-label

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number and Percentage of Participants Experiencing Adverse Events as Assessed by CTCAE v5.0 (Part 1 & 2)	Incidence and percentage of adverse events and serious adverse events will be collected from start of enrollment	20 months
Number and Percentage of Participants Experiencing Dose-limiting Toxicities	Number and percentage of participants experiencing dose-limiting toxicities (DLT) collected from start of enrollment through the first 28 days of Cycle 1 as assessed by CTCAE v5.0 (Part 1).	28 days
Maximum Plasma Concentration of KZR-261 (Part 1)	This is the maximum observed plasma concentration (Cmax) observed after administration of KZR-261 in Cycle 1 (Days 1 and 15) and Cycle 2 (Days 1 and 15). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose, 15 minutes post start of infusion, end of infusion, and 5, 15, 30 minutes, 1, 2, 4, 6, 24, 48, and 96 hours post infusion.	Cycle 1: Day 1, Cycle 1: Day 15, Cycle 2: Day 1, and Cycle 2: Day 15
The Plasma Concentration Time Curve of KZR-261 (Part 1)	This is the area under the curve (AUC) from predose through postdose observed after administration of KZR-261 in Cycle 1 (Days 1 and 15) and Cycle 2 (Days 1 and 15). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose, 15 minutes post start of infusion, end of infusion, and 5, 15, 30 minutes, 1, 2, 4, 6, and 24 hours post infusion.	Cycle 1: Day 1, Cycle 1: Day 15, Cycle 2: Day 1, and Cycle 2: Day 15

Secondary Outcomes

Measure	Description	Time Frame
Objective Response (ORR) Following KZR-261	The objective response following KZR-261 defined as a best overall response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR is defined as the disappearance of all target lesions and a PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of longest lesion diameters.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).
Disease that is resistant to or relapsed following available standard systemic therapy, or for which there is no standard systemic therapy or reasonable therapy in the Investigator's judgement likely to result in clinical benefit, or if such therapy has been refused by the subject. Documentation of the reason must be provided for subjects who have not received a standard therapy likely to result in clinical benefit.
Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
Adequate baseline hematologic and organ function.
Willing to use contraception.

Additional Inclusion for Part 2: Histologic or cytologic evidence of malignancy (melanoma/uveal melanoma, colorectal cancer, castration-resistant prostate cancer, mesothelioma).

Exclusion Criteria:

Subjects who have participated in Part 1 dose escalation are not eligible to enroll in Part 2 dose expansion.
Persistent clinically significant toxicities from previous anticancer therapy (excluding alopecia).
Treatment with cytotoxic, biologic, or targeted therapies for advanced cancer within 14 days before administration of the subject's first dose of KZR-261.
Treatment with an investigational drug within 28 days before administration of the subject's first dose of KZR-261.
Radiation therapy within 14 days of before administration of the subject's first dose of KZR-261.
Major surgical procedure within 28 days before administration of the subject's first dose of KZR-261.
History of risk factors for Torsades de pointes.
Active, symptomatic CNS metastases or primary CNS malignancy.
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).
Uncontrolled, clinically significant pulmonary disease.

Contacts/Locations Module

Name	Affiliation	Role
Kezar Study Director	Kezar Life Sciences, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Cedars Sinai Medical Center		Los Angeles	California	90048	United States
University of California Los Angeles

References Module

Label	URL
Kezar Life Sciences, Inc. corporate website	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
FG000	Dose 1	Participants received 1.8 mg/m^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
FG001	Dose 2	Participants received 3.6 mg/m^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
FG002	Dose 3	Participants received 7.2 mg/m^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
FG003	Dose 4	Participants received 12 mg/m^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
FG004	Dose 5	Participants received 18 mg/m^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
FG005	Dose 6	Participants received 27 mg/m^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
FG006	Dose 7	Participants received 40 mg/m^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
FG007	Dose 8	Participants received 60 mg/m^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
FG008	Dose 9	Participants received 80 mg/m^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
FG009	Melanoma Expansion Cohort	Participants received 60 mg/m^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0002 subjects FG0012 subjects FG0022 subjects FG0036 subjects FG0046 subjects FG0056 subjects FG0065 subjects FG00717 subjects FG0088 subjects FG0097 subjects
COMPLETED		FG0001 subjects FG0010 subjects FG0021 subjects FG0030 subjects FG004
NOT COMPLETED		FG0001 subjects FG0012 subjects FG0021 subjects FG0036 subjects FG004

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Dose 1	Participants received 1.8 mg/m^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
BG001	Dose 2	Participants received 3.6 mg/m^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number and Percentage of Participants Experiencing Adverse Events as Assessed by CTCAE v5.0 (Part 1 & 2)

Incidence and percentage of adverse events and serious adverse events will be collected from start of enrollment

All participants who received at least 1 dose of study treatment (KZR-261).

Posted

Number

participants

20 months

ID	Title	Description
OG000	Dose 1	Participants received 1.8 mg/m^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
OG001	Dose 2	Participants received 3.6 mg/m^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dose 1	Participants received 1.8 mg/m^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Regulatory Affairs	Kezar Life Sciences, Inc.	650-822-5600		clinicaltrials@kezarbio.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 2, 2023	Nov 11, 2025	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Aug 5, 2024	Nov 12, 2025	SAP_001.pdf

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D009362	Neoplasm Metastasis
D008545	Melanoma
D000098943	Uveal Melanoma
D015179	Colorectal Neoplasms
D008654	Mesothelioma

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Intervention Browse Module

ID	Term
D007267	Injections

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

Masking Info

EG0000 events0 affected2 at risk

EG0010 events0 affected2 at risk

EG0020 events0 affected2 at risk

EG0030 events0 affected6 at risk

EG0040 events0 affected6 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected5 at risk

EG0072 events2 affected17 at risk

EG0081 events1 affected8 at risk

EG0091 events1 affected7 at risk

EG0000 events0 affected2 at risk

EG0010 events0 affected2 at risk

EG0020 events0 affected2 at risk

EG0032 events2 affected6 at risk

EG0040 events0 affected6 at risk

EG0051 events1 affected6 at risk

EG0063 events2 affected5 at risk

EG0079 events5 affected17 at risk

EG0081 events1 affected8 at risk

EG0090 events0 affected7 at risk

NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.

OG00317.9(8.4 to NA)NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.

OG004NA(39.7 to NA)NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.

OG005NA(33.9 to NA)NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.

OG00653.4(11.7 to NA)NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.

OG00712.4(7.9 to 26.1)

OG008NA(9.3 to NA)NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.

OG00924.6(19.4 to NA)NA = Not calculable because the event of interest did not occur in a sufficient number of participants to allow estimation.

OG00825955.5± 154.2

OG00831491.0± 260.2

OG00818300.0± NAThe measure was only collected for one participant.

OG00837991.6± NAOnly one participant had measurements at this timepoint.