KT-333 for Lymphoma and Cancer

No longer recruiting at 13 trial locations

Overseen By Kymera Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kymera Therapeutics, Inc.

Disqualifiers: CNS metastases, CLL, other malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called KT-333, designed for individuals with certain types of relapsed or hard-to-treat cancers, such as lymphomas and solid tumors. The main goal is to assess the safety and tolerability of KT-333 at various doses. The trial also examines how the body processes the drug. It suits those who have tried other treatments without success and have specific conditions like T-cell leukemia or cutaneous T-cell lymphoma. Participants should have a type of cancer that has returned or not responded to at least one or two prior treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer.

Is there any evidence suggesting that KT-333 is likely to be safe for humans?

Research has shown that KT-333 was well tolerated in earlier studies. Most side effects were mild, such as mouth sores and tiredness, and were mostly low-grade, meaning they were not severe. Two cases involved more serious side effects, known as dose-limiting toxicities (DLTs), which help researchers determine safe dose levels. Overall, the early data suggest that KT-333 is fairly well-tolerated by patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for lymphomas and solid tumors involve chemotherapy, radiation, or targeted therapies like monoclonal antibodies. But KT-333 works differently, targeting specific proteins within cancer cells to disrupt their growth and survival. This approach is exciting because it offers a targeted mechanism of action that could potentially lead to fewer side effects compared to traditional chemotherapy. Researchers are particularly interested in how KT-333 might be effective against various types of lymphomas and solid tumors, offering a new option for patients who might not respond well to current treatments.

What evidence suggests that KT-333 might be an effective treatment for lymphoma and cancer?

Research suggests that KT-333, the investigational treatment in this trial, could help treat certain cancers. Early clinical results showed that some patients with different blood cancers experienced complete responses to the treatment. Studies have found that KT-333 reduces the activity of a protein called STAT3, which contributes to cancer growth. This reduction appeared in both the blood and tumors of patients, and the treatment was generally well-tolerated. Laboratory tests also demonstrated that KT-333 could shrink tumors in certain T-cell lymphomas. Overall, these findings indicate that KT-333 might effectively treat various cancers, but further research is needed to confirm these results. ^{1 3 4 6 7}

Who Is on the Research Team?

Ashwin Gollerkeri, MD

Principal Investigator

Kymera Therapeutics, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

LGL-L Patients with specific baseline disease characteristics

My disease has not responded to at least one standard treatment.

I have LGL leukemia or T-PLL and my previous treatments didn’t work or there are no standard treatments available for me.

Exclusion Criteria

I had a stem cell transplant using my own cells less than 3 months ago.

Patients with prior allogenic hematopoietic or bone marrow transplant

I do not have active, uncontrolled brain metastases or specific types of meningitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Dose Escalation

Participants receive escalating doses of KT-333 to evaluate safety, tolerability, and pharmacokinetics

28 days per cycle

Weekly visits for IV dosing

Phase 1b Dose Expansion

Participants are divided into cohorts to further evaluate safety and pharmacokinetics of KT-333

28 days per cycle

Weekly visits for IV dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KT-333

Trial Overview 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.

How Is the Trial Designed?

Group I: Phase 1b Dose Expansion Solid Tumor Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Group II: Phase 1b Dose Expansion PTCL Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Group III: Phase 1b Dose Expansion LGL-L Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Group IV: Phase 1b Dose Expansion CTCL Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Group V: Phase 1a Dose Escalation T-PLL Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Group VI: Phase 1a Dose Escalation Solid Tumors Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Group VII: Phase 1a Dose Escalation Lymphomas Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Group VIII: Phase 1a Dose Escalation LGL-L Experimental Treatment 1 Intervention

KT-333 dosed IV weekly in 28 day cycles

Who Is Running the Clinical Trial?

Kymera Therapeutics, Inc.

Lead Sponsor

Trials

8

Recruited

850+

Citations

1. investors.kymeratx.com investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-presents-new-clinical-data-ongoing-phase-1-0

Kymera Therapeutics Presents New Clinical Data from the ... KT-333 demonstrated initial clinical proof of concept across multiple hematological malignancies, including complete responses in two ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05225584

NCT05225584 | Safety, PK, PD, Clinical Activity of KT-333 ... This Phase 1a/1b study will evaluate the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of KT-333 in Adult patients with Relapsed or ...

3. kymeratx.com kymeratx.com/wp-content/uploads/2024/06/Kymera-Therapeutics-EHA-KT-333-Poster_June-2024.pdf

Kymera Therapeutics EHA KT-333 Poster_June 2024 Results overall show robust STAT3 knockdown and favorable immunomodulation in blood and tumor at doses that were well-tolerated and predicted to ...

4. onclive.com onclive.com/view/stat3-degrader-kt-333-is-well-tolerated-across-r-r-hematologic-malignancies-and-solid-tumors

STAT3 Degrader KT-333 is Well Tolerated Across R/R ... KT-333 was well tolerated in relapsed/refractory hematologic and solid tumor cancers, including cutaneous T-cell lymphoma and peripheral T-cell ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.TPS3171

Phase 1 study of KT-333, a targeted protein degrader, in ... In preclinical studies, durable tumor regressions were seen with weekly KT-333 administration in STAT3-dependent T cell lymphomas, and ...

6. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/3081/503133/Preliminary-Safety-Pharmacokinetics

Preliminary Safety, Pharmacokinetics, Pharmacodynamics ... Conclusion: The emerging clinical data demonstrate that KT-333 is a potent degrader of STAT3 as demonstrated in PBMCs at doses that are well ...

7. clfoundation.org clfoundation.org/safety-pk-pd-clinical-activity-kt-333-adult-patients-refractory-ly

Safety, PK, PD, Clinical Activity of KT-333 in Adult Patients ... This Phase 1a/1b study will evaluate the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of KT-333 in Adult patients with Relapsed or ...