Advanced Solid TumoursPhase 2NCT04564027
A Study Investigating DNA-damage Response Agents in Molecularly Altered Advanced Cancer
A Phase 2 study testing Ceralasertib in people with Advanced Solid Tumours, run by AstraZeneca at 18 sites in 3 countries.
Trial summary
The study is investigating efficacy, safety and tolerability of DNA-damage Response Agents (or Combinations), in participants with advanced/metastatic solid malignancies whose tumours contain molecular alterations Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Advanced Solid Tumours
- What is being tested?
- Ceralasertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 1 Dec 2020to 18 Feb 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a histologically confirmed diagnosis of AST (excluding NSCLC) or mCRPC tumour.
- Participants must have a deleterious or suspected deleterious ATM mutation in tumour or blood (germline or ctDNA). Definitions of qualifying ATM mutations may include deleterious/suspected deleterious, pathogenic/likely pathogenic, disease- or cancer-associated variants, or equivalent wording. Variants of unknown significance, benign or likely benign alterations are not qualifying.
- Participant must have normal organ and bone marrow function measured within 28 days prior to the first dose of study intervention.
- Participants who have no curative treatment options and are deemed appropriate for an investigational study in the opinion of the investigator.
- Availability of archival or fresh tumour specimens for central testing of ATM protein loss using immunohistochemistry and for confirmation of ATM mutation using next generation sequencing.
- Previously received and progressed on at least one novel hormonal agent (eg, abiraterone acetate, apalutamide, and/or enzalutamide) for the treatment of prostate cancer
Show all 9Show fewer
- Participants with histologically confirmed metastatic castrate resistant prostate cancer.
- Documented prostate cancer progression at study entry while on androgen deprivation or after bilateral orchiectomy as assessed by the investigator.
- Serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) within (≤) 28 days before enrolment.
Who cannot join
- Any of the following cardiac diseases currently or within the last 6 months:
- Unstable angina pectoris.
- Congestive heart failure > Class 2 as defined by the New York Heart Association
- Acute myocardial infarction.
- Significant ventricular or supraventricular arrhythmias.
- Mean resting corrected QT interval (QTc) > 470 msec obtained from three electrocardiograms (ECGs) in 24 hours using the Fredericia formula.
Show all 14Show fewer
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, immediate family history of long QT syndrome or unexplained sudden death under 40 years of age.
- For Cohort B (mCRPC]), surgery or local prostatic intervention (excluding a prostatic biopsy) within 28 days of Cycle 1 Day 1.
- Participants with known active infections ((i.e., hepatitis B or C, tuberculosis, or COVID-19).
- Participants considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
- Participants with symptomatic and/or uncontrolled brain metastases.
- Previous therapy with an telangiectasia and rad3 related protein inhibitor.
- Exposure to a small molecule investigational product within 14 days or 5 half-lives.
- Concomitant use of known strong CYP 3A inhibitors and inducers.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States12 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Baltimore, Maryland, 21231
Research Site
Duarte, California, 91010
Research Site
Ephrata, Pennsylvania, 17522
Research Site
Indianapolis, Indiana, 46202
Research Site
Las Vegas, Nevada, 89119
Research Site
Los Angeles, California, 90089
Research Site
Myrtle Beach, South Carolina, 29572
Research Site
New York, New York, 10065
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
San Francisco, California, 94115
Research Site
Tampa, Florida, 33612
France4 sites
Research Site
Bordeaux, 33076
Research Site
Dijon, 21079
Research Site
Lyon, 69373
Research Site
Vandœuvre-lès-Nancy, 54519
About this study
Official title: A Modular Phase 2a Multicentre Open-Label Study to Investigate DNA-damage Response Agents (or Combinations) in Patients With Advanced Cancer Whose Tumours Contain Molecular Alterations (PLANETTE)
The study is investigating efficacy, safety and tolerability of DNA-damage Response Agents (or Combinations), in participants with advanced/metastatic solid malignancies whose tumours contain molecular alterations
Read the detailed description
Current module of the study will consist of 2 cohorts as follows:
Cohort A (Advanced Solid Tumours [AST]): A total of ~25 molecularly eligible and centrally confirmed participants dosed at ceralasertib 160 mg twice daily will be enrolled into this cohort.
Cohort B (Metastatic castration-resistant prostate cancer [mCRPC]): A total of ~27 molecularly eligible and centrally confirmed participants dosed at ceralasertib 160 mg twice daily will be enrolled into Cohort B. Unfavourable circulating tumour cells (CTC) count requirement may be introduced for all participants to ensure an adequate (approximately ≥ 50%) number of participants with CTC count ≥ 5/7.5 mL blood.
The screening will have 2 parts, Part 1 and Part 2, which apply for both Cohort A and Cohort B.
- Conditions
- Advanced Solid Tumours
- Being tested
- Ceralasertib
- Keywords
- Ataxia telangiectasia mutated, Metastatic castration-resistant prostate cancer, Rad3-related protein
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeralasertibDrug
Also called AZD6738
Tablets will be administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Eligible participants (ATM altered AST), will receive oral dose of Ceralasertib as monotherapy. Receives: Drug: Ceralasertib |
| Cohort B | Experimental | Eligible participants (ATM altered mCRPC), will receive oral dose of Ceralasertib as monotherapy. Receives: Drug: Ceralasertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort A (aST): Objective Response Rate (ORR).
ORR is defined as the percentage of participants who have at least one response of complete response (CR) or partial response (PR) prior to any evidence of progression (as defined by response evaluation criteria in solid tumours [RECIST] 1.1) that is confirmed at least 4 weeks later. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion.
Due to an increased frequency and early onset of Grade≥3 hematological toxicity noted among the participants receiving 240 mg of Ceralsertib, the sponsor decreased the dose to 160mg. Therefore, patients with the 240 mg BID starting dose were not included in the efficacy analyses for both study cohorts.
Measured: 2 years 4 months
Cohort B (mCRPC): Composite Response Rate.
Composite response rate is defined as the investigator assessed radiological response by RECIST 1.1 for soft tissue and visceral lesions and Prostate Cancer Working Group 3 (PCWG3) for bone lesions, confirmed prostate specific antigen (PSA) decline of more than 50%, and/or confirmed circulating tumour cell [CTC] conversion from unfavorable (>=5 cells/7.5 ml blood) to favorable (<5 cells).
Due to an increased frequency and early onset of Grade≥3 hematological toxicity noted among the participants receiving 240 mg of Ceralsertib, the sponsor decreased the dose to 160mg. Therefore, patients with the 240 mg BID starting dose were not included in the efficacy analyses for both study cohorts.
Measured: Up to 2 years 4 months
Secondary outcomes (5)
Cohort A (aST): Duration of Radiological Response (DoR)
DoR is defined as the time from the date of first documented response (confirmed CR/PR) until date of documented progression or death in the absence of disease progression.
Measured: Up to 2 years 4 months
Cohort A (aST): Progression Free Survival (PFS)
PFS is defined as the time from start of study intervention until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy prior to progression. Progression is defined using (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Due to an increased frequency and early onset of Grade≥3 hematological toxicity noted among the participants receiving 240 mg of Ceralsertib, the sponsor decreased the dose to 160mg. Therefore, patients with the 240 mg BID starting dose were not included in the efficacy analyses for both study cohorts.
Measured: Up to 2 years 4 months
Cohort A (aST): Percentage Change in Tumor Size
Percentage change in tumour size is defined as the reduction from baseline or the increase from baseline in the absence of a reduction in the sum of the longest diameters (or the short axis measurements for lymph nodes) of the target lesions. A negative change denotes a reduction in target lesion size.
Measured: Scan Visits 1 (Week 8), 2 (Week 16), 3 (Week 24), 4 (Week 32), 5 (Week 40), 6 (Week (48), 7 (Week 56)
Cohort B (mRCPC): Percentage Change in Tumor Size
Percentage change in tumour size is defined as the reduction from baseline or the increase from baseline in the absence of a reduction in the sum of the longest diameters (or the short axis measurements for lymph nodes) of the target lesions. A negative change denotes a reduction in target lesion size.
Due to an increased frequency and early onset of Grade≥3 hematological toxicity noted among the participants receiving 240 mg of Ceralsertib, the sponsor decreased the dose to 160mg. Therefore, patients with the 240 mg BID starting dose were not included in the efficacy analyses for both study cohorts.
Measured: Scan Visits 1 (Week 8), 2 (Week 16), 3 (Week 24), 4 (Week 32)
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
The adverse events as a variable of safety and tolerability after admiration of ceralasertib was determined.
Measured: From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Dec 2020
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid TumoursStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564027
- Sponsor's protocol ID
- D5339C00001
- Other IDs
- 2024-515102-12-00, 2020-002529-27
- Status last verified
- Aug 2025
- First submitted
- 8 Sep 2020
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the requests portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modular Phase 2a Multicentre Open-Label Study to Investigate DNA-damage Response Agents (or Combinations) in Patients With Advanced Cancer Whose Tumours Contain Molecular Alterations (PLANETTE)
- ClinicalTrials.gov ID
- NCT04564027
- Acronym / sponsor ID
- D5339C00001
- Conditions
- Advanced Solid Tumours
- Keywords
- Ataxia telangiectasia mutated, Metastatic castration-resistant prostate cancer, Rad3-related protein
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Posted 25 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is investigating efficacy, safety and tolerability of DNA-damage Response Agents (or Combinations), in participants with advanced/metastatic solid malignancies whose tumours contain molecular alterations
Detailed description
Current module of the study will consist of 2 cohorts as follows:
Cohort A (Advanced Solid Tumours [AST]): A total of ~25 molecularly eligible and centrally confirmed participants dosed at ceralasertib 160 mg twice daily will be enrolled into this cohort.
Cohort B (Metastatic castration-resistant prostate cancer [mCRPC]): A total of ~27 molecularly eligible and centrally confirmed participants dosed at ceralasertib 160 mg twice daily will be enrolled into Cohort B. Unfavourable circulating tumour cells (CTC) count requirement may be introduced for all participants to ensure an adequate (approximately ≥ 50%) number of participants with CTC count ≥ 5/7.5 mL blood.
The screening will have 2 parts, Part 1 and Part 2, which apply for both Cohort A and Cohort B.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: CeralasertibEligible participants (ATM altered AST), will receive oral dose of Ceralasertib as monotherapy. |
| Cohort B | Experimental | Drug: CeralasertibEligible participants (ATM altered mCRPC), will receive oral dose of Ceralasertib as monotherapy. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must have a histologically confirmed diagnosis of AST (excluding NSCLC) or mCRPC tumour.
- Participants must have a deleterious or suspected deleterious ATM mutation in tumour or blood (germline or ctDNA). Definitions of qualifying ATM mutations may include deleterious/suspected deleterious, pathogenic/likely pathogenic, disease- or cancer-associated variants, or equivalent wording. Variants of unknown significance, benign or likely benign alterations are not qualifying.
- Participant must have normal organ and bone marrow function measured within 28 days prior to the first dose of study intervention.
- Participants who have no curative treatment options and are deemed appropriate for an investigational study in the opinion of the investigator.
- Availability of archival or fresh tumour specimens for central testing of ATM protein loss using immunohistochemistry and for confirmation of ATM mutation using next generation sequencing.
Key exclusion criteria (14 listed)
- Any of the following cardiac diseases currently or within the last 6 months:
- Participants with known active infections ((i.e., hepatitis B or C, tuberculosis, or COVID-19).
- Participants considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
- Participants with symptomatic and/or uncontrolled brain metastases.
- Previous therapy with an telangiectasia and rad3 related protein inhibitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeralasertibAlso: AZD6738Tablets will be administered orally | Drug | Cohort A, Cohort B |
Primary outcome
Cohort A (aST): Objective Response Rate (ORR).
Time frame: 2 years 4 months
ORR is defined as the percentage of participants who have at least one response of complete response (CR) or partial response (PR) prior to any evidence of progression (as defined by response evaluation criteria in solid tumours [RECIST] 1.1) that is confirmed at least 4 weeks later. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. Due to an increased frequency and early onset of Grade≥3 hematological toxicity noted among the participants receiving 240 mg of Ceralsertib, the sponsor decreased the dose to 160mg. Therefore, patients with the 240 mg BID starting dose were not included in the efficacy analyses for both study cohorts.
Cohort B (mCRPC): Composite Response Rate.
Time frame: Up to 2 years 4 months
Composite response rate is defined as the investigator assessed radiological response by RECIST 1.1 for soft tissue and visceral lesions and Prostate Cancer Working Group 3 (PCWG3) for bone lesions, confirmed prostate specific antigen (PSA) decline of more than 50%, and/or confirmed circulating tumour cell [CTC] conversion from unfavorable (>=5 cells/7.5 ml blood) to favorable (<5 cells). Due to an increased frequency and early onset of Grade≥3 hematological toxicity noted among the participants receiving 240 mg of Ceralsertib, the sponsor decreased the dose to 160mg. Therefore, patients with the 240 mg BID starting dose were not included in the efficacy analyses for both study cohorts.
5 secondary outcomes
Cohort A (aST): Duration of Radiological Response (DoR)
Time frame: Up to 2 years 4 months
Cohort A (aST): Progression Free Survival (PFS)
Time frame: Up to 2 years 4 months
Cohort A (aST): Percentage Change in Tumor Size
Time frame: Scan Visits 1 (Week 8), 2 (Week 16), 3 (Week 24), 4 (Week 32), 5 (Week 40), 6 (Week (48), 7 (Week 56)
Cohort B (mRCPC): Percentage Change in Tumor Size
Time frame: Scan Visits 1 (Week 8), 2 (Week 16), 3 (Week 24), 4 (Week 32)
Cohort A (aST) and B (mCRPC): Number of Participants With Serious and Non-serious Adverse Events
Time frame: From Screening (Day -28 to Day -1) Until Follow-up (30 days post last dose), up to 2 years 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- CSP\_redactedLink provided by the sponsor.
- CSR Synopsis\_redactedLink provided by the sponsor.
- SAP\_redactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the requests portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Related trials for Advanced Solid Tumours
RecruitingPhase 1
A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
Personalized KXV01 Lentinvivo (TCR) Injection as the Therapy for Advanced Solid Tumors
Advanced Solid Tumors
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ceralasertib in people with Advanced Solid Tumours, run by AstraZeneca at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort A (aST): Objective Response Rate (ORR). (time frame: 2 years 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.