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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline scan until first documented progression or death from any cause, whichever comes first, about 18 months
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of KT-253 to treat relapsed and advanced cancers, such as leukemia, lymphoma, and solid tumors.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, typical ones may include reactions at the infusion site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding tendencies. Side effects will be closely monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline scan until first documented progression or death from any cause, whichever comes first, about 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline scan until first documented progression or death from any cause, whichever comes first, about 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of adverse events
Maximum Tolerated Dose (MTD) and recommended Phase 2 dose (RP2D) in Patients
Secondary outcome measures
Area under the Plasma Concentration versus Time Curve (AUC) of KT-253
Duration of Response (DoR) in Patients Treated with KT-253
Evidence of Clinical activity of KT-253 in ALL patients
+7 moreTrial Design
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
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 LymphomasExperimental Treatment1 Intervention
KT-253 dosed intravenous (IV) once every three weeks in 21-day cycles
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Who is running the clinical trial?
Kymera Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
608 Total Patients Enrolled
Ashwin Gollerkeri, MDStudy DirectorKymera Therapeutics, Inc.
4 Previous Clinical Trials
354 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.I have advanced leukemia and signs of it in my brain or spinal cord.My cancer is a solid tumor or lymphoma, confirmed by lab tests.I haven't had chemotherapy or radiation in the last 2 weeks.I have been cancer-free for at least 2 years if I had another type of cancer.My organs are working well.I can take care of myself and am up and about more than half of the day.I have active brain metastases that are not under control or causing symptoms.My leukemia or myeloid disease has not responded to standard treatments.My cancer has not responded to at least two treatments or there are no standard treatments available for it.I had a stem cell transplant within the last 6 months or my lymphoma worsened within 6 months after the transplant.I haven't had cancer treatment or experimental drugs in the last 2 to 4 weeks.I have not had major surgery within the last 4 weeks.I had a stem cell transplant less than 12 weeks ago or a donor immune cell infusion without special preparation less than 4 weeks ago.I had a stem cell transplant less than 4 weeks ago or haven't recovered from its side effects.My side effects from previous treatments are mild or gone, except for hair loss and some nerve pain.I have advanced blood cancer and received a special immune therapy less than 3 weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Dose Escalation Arm A in patients with R/R Solid Tumors and Lymphomas
- Group 2: Phase 1 Dose Escalation Arm B in patients with R/R High Grade Myeloid Malignancies and ALL
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Phase 1 Dose Escalation Arm A for use in those with recurrent or refractory solid tumors and lymphomas?
"Our analysts at Power gave Phase 1 Dose Escalation Arm A a safety score of one due to the fact that there is only limited data available pertaining to its efficacy and safety in patients with relapsed/refractory solid tumors and lymphomas."
Answered by AI
Are researchers recruiting participants for the current trial?
"Clinicaltrials.gov shows that this medical trial is currently searching for participants; it was originally launched on March 1st 2023, and the latest update happened on March 27th 2023."
Answered by AI
How many individuals are engaging in this medical experiment?
"Affirmative. Based on the information available from clinicaltrials.gov, this medical experiment is still actively recruiting participants and was initially posted on March 1st 2023 with its most recent update occurring on March 27th 2023. The investigatory team requires 60 volunteers at a single research site."
Answered by AI
What positive results are expected from this experiment?
"According to the trial sponsor, Kymera Therapeutics Inc., the primary objective of this study is to measure adverse events over a 30-day period. Additionally, there are multiple secondary objectives such as measuring response rate in R/R lymphoma patients per Lugano criteria 2014 and recording complete remission and partial remission rates for those suffering from high-risk MDS via IWG guidelines or hematological remissions according to NCCN standards for ALL sufferers."
Answered by AI
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