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ATR Kinase Inhibitor
Ceralasertib + Olaparib/Durvalumab for Cancer
Phase 2
Recruiting
Led By Rahul Aggarwal, MD
Research Sponsored by Rahul Aggarwal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Endometrial Cancer Cohort: Histologically confirmed endometrial cancer with specific genetic alteration requirements and disease measurement criteria
ARID1A Subgroup: Histologically confirmed locally advanced or metastatic solid tumor malignancy with progression on at least one prior systemic therapy, including specific tumor types and requirements for tumor tissue evaluation and disease measurement
Must not have
Contraindications related to medication use, hypersensitivity reactions, chronic active hepatitis B or C, and immunocompromised status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Summary
This trial is testing a new drug called ceralasertib to see if it can stop the growth of advanced cancers. It targets patients with various types of advanced solid tumors. The treatment works by blocking enzymes that cancer cells need to grow.
Who is the study for?
This trial is for adults with advanced or metastatic solid tumors, including kidney, pancreatic, endometrial and prostate cancers. Participants must have progressed on prior therapy and have measurable disease. They need adequate organ function, available tumor tissue samples, and must agree to use effective contraception.
What is being tested?
The study tests the effectiveness of Ceralasertib alone or combined with Olaparib or Durvalumab in treating various solid tumors. It aims to see if blocking certain enzymes needed for cell growth can control tumor progression better than current treatments.
What are the potential side effects?
Potential side effects may include fatigue, nausea, skin reactions at the injection site for Durvalumab, anemia from Olaparib, as well as possible liver enzyme changes due to Ceralasertib. The severity of side effects varies among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My endometrial cancer has been confirmed with specific genetic changes.
Select...
My cancer has spread, worsened after treatment, and requires specific tissue tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I don't have allergies to medications, chronic hepatitis B or C, or a weakened immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite Prostate Cancer Patient Response Rate (prostate cancer only)
Objective response rate (ORR) (ARID1A cohort)
Objective response rate (ORR) for endometrial cohort
+1 moreSecondary study objectives
Median Overall Survival (Endometrial cohort only)
Median duration of response (DOR) by disease group
Median duration of response (DOR) by treatment regimen
+9 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Arm III (Ceralasertib, Durvalumab)Experimental Treatment2 Interventions
In combination with durvalumab, ceralasertib will be given at a continuous daily dose of 240 mg BID days 1-7 of a 28-day dosing schedule. Durvalumab will be given at a flat dose of 1500 mg IV on day 8 of a 28-day cycle for participants with histologically confirmed endometrial cancers. Participants treated with the combination of ceralasertib plus durvalumab may continue treatment beyond first radiographic progression until the occurrence of either confirmed radiographic progression or clinical progression, whichever occurs first.
Group II: Arm II (Ceralasertib, Olaparib)Experimental Treatment2 Interventions
In combination with olaparib, ceralasertib will be given at a continuous daily dose of 160 mg daily days 1-7 in each 28-day cycle. Olaparib will be given at a starting dose of 300 mg twice daily days 1-28 of a 28-day cycle for participants who are BAF250a positive. Treatment will continue until disease progression, unacceptable toxicity, or participant withdrawal from study, whichever occurs first.
Group III: Arm I (Ceralasertib Monotherapy)Experimental Treatment1 Intervention
As monotherapy ceralasertib will be given at a starting dose of 160 mg two times per day (BID), on days 1-14 of a 28-day cycle for participants who are BAF250a negative or show an ATM-Mutation by CLIA assay. Treatment will continue until disease progression, unacceptable toxicity, or participant withdrawal from study, whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2190
Ceralasertib
2017
Completed Phase 1
~40
Durvalumab
2017
Completed Phase 2
~3780
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for prostate cancer include androgen receptor signaling inhibitors like enzalutamide and apalutamide, which block androgen binding and inhibit receptor translocation to the nucleus, thereby reducing cancer cell proliferation. DNA damage response inhibitors, such as the ATR kinase inhibitor AZD6738, disrupt the cell's ability to repair DNA damage, leading to cell cycle arrest and apoptosis.
These mechanisms are crucial for prostate cancer patients as they target the cancer cells' survival pathways, potentially improving treatment efficacy and patient outcomes.
ATR and p-ATR are emerging prognostic biomarkers and DNA damage response targets in ovarian cancer.Apalutamide Sensitizes Prostate Cancer to Ionizing Radiation via Inhibition of Non-Homologous End-Joining DNA Repair.Inhibition of the ATR kinase enhances 5-FU sensitivity independently of nonhomologous end-joining and homologous recombination repair pathways.
ATR and p-ATR are emerging prognostic biomarkers and DNA damage response targets in ovarian cancer.Apalutamide Sensitizes Prostate Cancer to Ionizing Radiation via Inhibition of Non-Homologous End-Joining DNA Repair.Inhibition of the ATR kinase enhances 5-FU sensitivity independently of nonhomologous end-joining and homologous recombination repair pathways.
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Who is running the clinical trial?
Rahul AggarwalLead Sponsor
12 Previous Clinical Trials
457 Total Patients Enrolled
7 Trials studying Prostate Cancer
278 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
4,370 Previous Clinical Trials
288,737,606 Total Patients Enrolled
60 Trials studying Prostate Cancer
27,732 Patients Enrolled for Prostate Cancer
Rahul Aggarwal, MDPrincipal Investigator - University of California, San Francisco
UCSF Medical Center at Parnassus
Northwestern University Medical Sch (Medical School)
22 Previous Clinical Trials
1,322 Total Patients Enrolled
13 Trials studying Prostate Cancer
1,043 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I meet specific health, treatment history, and contraception use criteria.I don't have allergies to medications, chronic hepatitis B or C, or a weakened immune system.I haven't been treated for another cancer within the last year.My cancer has spread, worsened after treatment, and lacks ATM protein.My endometrial cancer has been confirmed with specific genetic changes.I don't have a history of specific health issues like recent major surgeries or untreated brain metastases.My cancer has spread, worsened after treatment, and requires specific tissue tests.
Research Study Groups:
This trial has the following groups:- Group 1: Arm III (Ceralasertib, Durvalumab)
- Group 2: Arm I (Ceralasertib Monotherapy)
- Group 3: Arm II (Ceralasertib, Olaparib)
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.
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