What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapy, targeted therapy, and immunotherapy, often have overlapping side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and blood-related issues like neutropenia and anemia. Targeted therapies may lead to diarrhea, liver dysfunction, and skin rashes. Immunotherapies can result in immune-related adverse events such as pneumonitis, colitis, hepatitis, and endocrinopathies. The investigational agent KZR-261, being studied for its anti-tumor activity, is likely to share some of these side effects, particularly those related to immune modulation and targeted action.

What prior FDA approvals exist?

Several FDA-approved treatments for solid tumors include tyrosine kinase inhibitors (TKIs) like pazopanib and regorafenib, which target multiple kinases involved in tumor growth and angiogenesis. Immunotherapy agents such as pembrolizumab and nivolumab, which are immune checkpoint inhibitors, have also been approved for various solid tumors, including melanoma and non-small cell lung cancer. Additionally, chemotherapeutic agents like gemcitabine and docetaxel are commonly used in the treatment of solid tumors. These treatments have shown efficacy in clinical trials and are part of the standard care for many types of solid malignancies.

What other types of research exist?

Promising novel alternatives to KZR-261 for solid tumor patients include: 1) Infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor, which has shown efficacy in cholangiocarcinoma with FGFR2 gene fusions. 2) Futibatinib, another FGFR inhibitor, which has received accelerated approval for cholangiocarcinoma. 3) SB1317/TG02, a potent inhibitor of CDKs, JAK2, and FLT3, currently in phase 1 trials for advanced leukemias and multiple myeloma, but potentially applicable to solid tumors.

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Monoclonal Antibodies

KZR-261 for Cancer

Phase 1

Waitlist Available

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

Must not have

Uncontrolled, clinically significant pulmonary disease

Major surgical procedure within 28 days before administration of the subject's first dose of KZR-261

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 20 months

Awards & highlights

Summary

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.

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.

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.

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 below

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

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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

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I have risk factors for a rare heart rhythm condition.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 20 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 20 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 20 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

Duration of response (DOR) of KZR-261

Objective Response Rate (ORR) of KZR-261

Overall Survival of Patients treated with KZR-261

+1 more

Trial 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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include targeted therapies, chemotherapy, and immunotherapy. Targeted therapies, like tyrosine kinase inhibitors, block specific molecules that drive tumor growth. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells. Immunotherapy enhances the immune system's ability to recognize and destroy cancer cells. These mechanisms are vital for solid tumor patients as they allow for personalized treatment plans that can improve efficacy and reduce side effects.