KT-333 for Lymphoma and Cancer

Phase 1

Recruiting

Research Sponsored by Kymera Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening and C1D1 (pre-dose)

Patients with adequate liver/kidney organ function at Screening and C1D1 (pre-dose)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first of response to the date of documented first progression or death whichever comes first, about 18 months

Awards & highlights

Study Summary

This trial will study the safety and how well KT-333 works in treating patients with relapsed or refractory lymphomas, large granular lymphocytic leukemia, and solid tumors.

Who is the study for?

Adults with certain types of blood cancers or solid tumors that haven't responded to standard treatments can join this trial. They should have a specific level of white blood cells, be in fair health (ECOG 0-2), and women must use effective birth control. People with brain metastases, another active cancer besides lymphoma or solid tumors, recent transplants, or unresolved treatment side effects are excluded.Check my eligibility

What is being tested?

The study is testing KT-333's safety and how the body processes it in two phases: Phase 1a tests increasing doses on various cancers; Phase 1b focuses on Peripheral T-cell Lymphoma, Cutaneous T-Cell Lymphoma, Large Granular Lymphocytic Leukemia, and solid tumors to further understand KT-333's effects.See study design

What are the potential side effects?

While the specific side effects for KT-333 aren't listed here, common ones for cancer drugs include nausea, fatigue, risk of infection due to low blood cell counts, liver/kidney issues from organ inflammation. Patients will be monitored closely for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself and am up and about more than 50% of my waking hours.

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My liver and kidneys are working well.

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I have T-PLL with measurable disease or atypical T cells in my blood or bone marrow.

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My cancer can be measured by tests.

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I have LGL leukemia with severe low white blood cell count, significant tiredness due to low red blood cell count, or need regular blood transfusions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first of response to the date of documented first progression or death whichever comes first, about 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first of response to the date of documented first progression or death whichever comes first, about 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first of response to the date of documented first progression or death whichever comes first, about 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Limiting Toxicities (DLTs)

Maximum Tolerated Dose (MTD)

Safety

Secondary outcome measures

Amount of KT-333 dose excreted in urine from time zero to last collected time point (Ae0-t)

Area under the plasma concentration versus time curve for KT-333

Duration of Response (DOR)

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