KT-253 for Cancer

Recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kymera Therapeutics, Inc.

Must not be taking: Anticancer, Immunotherapy, Investigational, others

Disqualifiers: Unstable cardiovascular, CNS metastases, others

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

Compensation: Varies

Number of Visits: 3

Duration: 18 months

52 Participants Needed

Trial Summary

What is the purpose of this trial?

This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and clinical activity of KT-253 in adult patients with relapsed or refractory (R/R) high grade myeloid malignancies, acute lymphocytic leukemia (ALL), R/R lymphoma, myelofibrosis, and R/R solid tumors. The study will identify the pharmacologically optimal dose(s) (MTD) of KT-253 as the recommended Phase 2 dose (RP2D), based on all safety, PK, PD, and efficacy data.

Research Team

Ashwin Gollerkeri, MD

Principal Investigator

Kymera Therapeutics, Inc.

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Phase 1 Dose Escalation Arm B in patients with R/R High Grade Myeloid Malignancies and ALL Experimental Treatment 1 Intervention

KT-253 dosed IV once every three weeks in 21-day cycles

Group II: Phase 1 Dose Escalation Arm A in patients with R/R Solid Tumors and Lymphomas Experimental Treatment 1 Intervention

KT-253 dosed intravenous (IV) once every three weeks in 21-day cycles

Who Is Running the Clinical Trial?

Kymera Therapeutics, Inc.

Lead Sponsor

Trials

8

Recruited

850+