KT-253 for Cancer

No longer recruiting at 11 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called KT-253 for individuals whose cancer has returned or resisted other treatments. It targets several cancer types, including certain blood cancers like acute lymphocytic leukemia (ALL), myeloid malignancies, solid tumors, and lymphomas. The primary goal is to determine the safest and most effective dose of KT-253. This trial may suit those who have tried at least two other treatments without success. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have had certain cancer treatments or investigational therapies within a specific time before starting the trial, such as 2 weeks for anticancer therapy or 4 weeks for immunotherapy.

Is there any evidence suggesting that KT-253 is likely to be safe for humans?

Research has shown that KT-253 was generally well-tolerated in earlier studies. Most patients experienced mild side effects such as nausea, tiredness, headache, and vomiting. These side effects are common and usually not serious. The treatment targets a protein called MDM2, which helps control another protein related to cancer, called p53. In some lab tests, KT-253 showed promise by activating p53 and helping to kill cancer cells.

Although this trial is in an early stage, previous evidence suggests KT-253 is relatively safe for humans. This early phase focuses on finding the right dose and checking for any possible side effects. While it's still early, existing data provides some reassurance about the treatment’s safety.12345

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about KT-253 because it offers a novel approach to tackling resistant cancers. Unlike traditional treatments that may rely on chemotherapy or radiation, KT-253 is designed to target specific cancer cells more precisely, potentially leading to fewer side effects and improved efficacy. This drug is administered intravenously every three weeks, offering a more manageable schedule for patients. Its unique mechanism of action is what sets it apart, as it targets pathways that are less affected by existing therapies, offering hope for more effective treatment options for patients with difficult-to-treat solid tumors, lymphomas, and high-grade myeloid malignancies.

What evidence suggests that KT-253 might be an effective treatment for cancer?

Research has shown that KT-253 is a promising treatment for various types of cancer. It targets a protein called MDM2, which can prevent another protein, p53, from stopping tumor growth. KT-253 helps break down MDM2, allowing p53 to better fight cancer cells. Early studies have demonstrated that KT-253 can effectively shrink tumors in cancers like Merkel cell carcinoma and acute myeloid leukemia. In both lab and animal studies, KT-253 showed strong and lasting effects against tumors. This trial includes two separate treatment arms: one for patients with relapsed or refractory solid tumors and lymphomas, and another for those with relapsed or refractory high-grade myeloid malignancies and acute lymphocytic leukemia. These findings offer hope for people with high-grade myeloid cancers, acute lymphocytic leukemia, lymphoma, and solid tumors.12356

Who Is on the Research Team?

AG

Ashwin Gollerkeri, MD

Principal Investigator

Kymera Therapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced cancers like high grade myeloid malignancies, ALL, lymphoma, and solid tumors that have not responded to standard treatments. Participants must be in fairly good physical condition (ECOG 0-2), have recovered from previous therapies, and should not have had major surgery or cancer therapy too close to the start of the study.

Inclusion Criteria

My cancer is a solid tumor or lymphoma, confirmed by lab tests.
My organs are working well.
I can take care of myself and am up and about more than half of the day.
See 3 more

Exclusion Criteria

My tumor has a p53 mutation.
My heart condition is stable.
I have advanced blood cancer and no recent severe graft versus host disease.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KT-253 intravenously once every three weeks in 21-day cycles for dose escalation

18 months
Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • KT-253
Trial Overview KT-253 is being tested in this Phase 1 trial to determine its safety and effectiveness for treating various relapsed/refractory cancers. The study aims to find the best dose based on how patients react and any signs of improvement in their conditions.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Phase 1 Dose Escalation Arm B in patients with R/R High Grade Myeloid Malignancies and ALLExperimental Treatment1 Intervention
Group II: Phase 1 Dose Escalation Arm A in patients with R/R Solid Tumors and LymphomasExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kymera Therapeutics, Inc.

Lead Sponsor

Trials
8
Recruited
850+

Citations

Safety, pharmacokinetics (PK), pharmacodynamics (PD) ...KT-253 is a novel, highly potent heterobifunctional MDM2 degrader that upregulates p53 activity and overcomes the p53-MDM2 feedback loop.
Safety and Clinical Activity of KT-253 in Adult Patients ...This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and clinical activity of KT-253 in adult patients with ...
Release DetailsThe Phase 1 study of KT-253 will evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and clinical activity of KT-253 in patients with ...
KT-253, a Novel MDM2 Degrader and p53 Stabilizer, Has ...A single intravenous dose of KT-253 triggered rapid apoptosis and sustained tumor regression in p53 wild-type acute myeloid leukemia and acute ...
MDM2 degrader KT-253 shows promise for treating p53 ...In cellular and animal models, KT-253 demonstrated potent and sustained antitumor activity. A single intravenous dose was sufficient to induce ...
Safety and Clinical Activity of KT-253 in Adult Patients ...This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and clinical activity of KT-253 in adult patients.
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