Solid TumorPhase 1POP-ARTNCT06337630
A Study on Tuvusertib (Oral ATR Inhibitor) in Combination With PLX038 (Topo1 Inhibitor) in Patients With Advanced Solid Tumors
A Phase 1 study testing PLX038 + Tuvusertib in people with Solid Tumor, run by Institut Curie at 2 sites in France.
Trial summary
Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- PLX038 + Tuvusertib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Jan 2025to 24 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to comply with the protocol and provide written informed consent prior to study-specific screening procedures.
- Age ≥ 18 years.
- Locally advanced or metastatic solid cancer that is not amenable to curative treatment.
- Measurable disease (per RECIST version 1.1).
- Received a minimum of one and a maximum of six prior cytotoxic chemotherapy regimens for locally advanced or metastatic cancer.
- Resolution of chemotherapy and radiation therapy related toxicities to NCI-CTCAE version 5.0 Grade 1 or lower severity, except for stable sensory neuropathy (≤ Grade 2), alopecia (any grade), presence of clinically managed chronic autoimmune AEs from prior immune therapy.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function (obtained within 14 days prior to treatment start) as evidenced by:
- Absolute neutrophil count (ANC) ≥ 1.5 X 109/L; ii. Hemoglobin (Hgb) ≥ 9 g/dL; iii. Platelet count ≥ 100 X 109/L; iv. Bilirubin ≤ 1.5 X upper limit of normal (ULN), except for patients with a documented history of Gilbert's disease (≤ 2 X ULN); v. Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 2.5 X ULN (for patients with liver metastases ≤ 5 X ULN); vi. Alkaline phosphatase (ALP) ≤ 3 X ULN (for patients with liver metastases, ≤ 5 X ULN); vii. Serum creatinine ≤ 1.5 mg/dL (133 μmol/L) or calculated creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula); viii. Women of childbearing potential (WCBP): negative serum pregnancy test.
- Full blood count parameters described above must meet the thresholds with no transfusion or growth factor support in the past 14 days.
- Patients covered by social security or health insurance in compliance with the national legislation relating to biomedical research.
- The willingness to remain on contraception of childbearing potential for the duration of study treatment plus 7 months (women) or 4 months (men).
Who cannot join
- Patients who have had a last dose of IV chemotherapy within 21 days, last dose of oral cytotoxic chemotherapy, radiotherapy, biological therapy, or investigational therapy within 14 days prior to treatment start.
- Patients who have had any major surgery within 28 days prior to inclusion.
- Patients with chronic inflammatory bowel disease and/or bowel obstruction.
- Concomitant use of other agents for the treatment of cancer (except for LHRH agonist/antagonist) or any investigational agent(s).
- Brain metastases, unless local therapy was completed and use of corticosteroids for this indication discontinued for at least 3 weeks prior to inclusion. Signs or symptoms of brain metastases must be stable for at least 28 days prior to inclusion. No known progression of brain metastases (by imaging as assessed by RECIST version 1.1) can have occurred. Patients with leptomeningeal disease or meningeal carcinomatosis are excluded.
- Women who are either pregnant, lactating, planning to get pregnant.
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- Patients receiving pharmacotherapy for hepatitis B or C, tuberculosis, or HIV.
- Patients with known liver disease diagnosed with Child-Pugh A or higher cirrhosis.
- Other current or previous stage III or IV malignancy diagnosed within 5 years of study entry.
- Severe/uncontrolled intercurrent illness within the previous 28 days prior to inclusion.
- Uncontrolled or poorly controlled arterial hypertension, symptomatic congestive heart failure (New York Heart Association Classification ≥ Class III), uncontrolled cardiac arrhythmia, calculated QTc average using the QTcF > 480 msec; unstable angina pectoris, myocardial infarction or a coronary revascularization procedure, cerebral vascular accident, transient ischemic attack, or any other significant vascular disease within 180 days of study intervention start.
- Patients with ongoing active infection (requiring systemic treatment) and treatment with live or live attenuated vaccine within 30 days of dosing.
- Any other significant medical, psychological, social or geographic conditions that in the opinion of the Investigator would impair study participation or cooperation.
- Patients deprived of their liberty or under guardianship.
- Dose expansion additional inclusion criteria
- Breast cancer
- Triple-negative breast cancer (both ER and PR <10%, HER2-negative or HER2-low, locally assessed).
- Prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, taxane and sacituzumab govitecan (unless not medically appropriate or contraindicated for the patient).
- Patients with known gBRCA mutations must have received a PARP inhibitor in the metastatic setting.
- Patients whose cancer has a CPS score ≥10 must have received prior pembrolizumab unless (i) contra-indicated (ii) CPS score or pembrolizumab not available at time of first line treatment start.
- ATM-mutated solid cancers
- ● Inactivating mutation of ATM (presence of truncating mutation or R337/R3008 missense mutation of ATM mono and/or biallelic, assessed by next-generation sequencing in a certified French genomics platform).
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase I Study on Tuvusertib (Oral ATR Inhibitor) in Combination With PLX038 (Topo1 Inhibitor) With Dose Expansion Cohorts in Patients With Advanced Solid Tumors
Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types.
Read the detailed description
This is an open label, multi-centric phase I with, first, a dose escalation step using an adaptation of the Bayesian Optimal INterval (BOIN) drug-combination, followed by 2 dose expansion cohorts using the Simon 2-stage design.
Dose escalation step Dose escalation will be conducted on the grid defined by the 4 doses of PLX038 (800 mg/m², 1000 mg/m², 1300 mg/m² and 1700 mg/m² IV every 21 days D1=D22) and 3 doses of Tuvusertib (90 mg, 130 mg and 180 mg QD for 10 days from D3, D3-12). Premedication with anti-emetic agents is not required prior to the initial infusion, but may be used for an individual patient, as needed.
starting combination level is c1 (PLX038 800mg/m2 and Tuvusertib 90mg). Groups of 3 patients will be sequentially enrolled. One week between the enrollment of the 1st patient and the 2 following patients is mandatory at a new combination level. The decision to (de)-escalate one of the two agents depends on the outcome of all patients treated at the current combination.
Expansion cohorts Two expansion cohorts are planned, investigating the efficacy and safety in pre-specified populations of interest.
Patients will be treated at the RP2D; 25 evaluable patients are needed in each cohort, to account for possible non evaluable patients, up to 28 patients will be enrolled in each cohort.
Patients enrolled in the phase I part at the RP2D and fulfilling the eligibility criteria of one of the expansion cohorts will be counted in those 25 evaluable patients.
- Conditions
- Solid Tumor
- Being tested
- PLX038 + Tuvusertib
- Keywords
- Pretreated, Metastatic, Locally, Advanced triple negative breast, ATM Gene Mutation
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLX038 + TuvusertibDrug
Dose escalation will be conducted on the grid defined by the 4 doses of PLX038 (800 mg/m², 1000 mg/m², 1300 mg/m² and 1700 mg/m² IV every 21 days D1=D22) and 3 doses of Tuvusertib (90 mg, 130 mg and 180 mg QD for 10 days from D3, D3-12). Premedication with anti-emetic agents is not required prior to the initial infusion, but may be used for an individual patient, as needed.
All included patients will receive PLX038 + Tuvusertib until progression of disease, unacceptable toxicity, patient withdrawal of consent, investigator decision, lost to follow-up, death, patient non-compliance, or study termination by Sponsor.
| Study group | Role | What they receive |
|---|---|---|
| Single arm: treatment with PLX038 and Tuvusertib | Experimental | Dose escalation step Dose escalation will be conducted on the grid defined by the 4 doses of PLX038 (800 mg/m², 1000 mg/m², 1300 mg/m² and 1700 mg/m² IV every 21 days D1=D22) and 3 doses of Tuvusertib (90 mg, 130 mg and 180 mg QD for 10 days from D3, D3-12). Premedication with anti-emetic agents is not required prior to the initial infusion, but may be used for an individual patient, as needed.
Expansion cohorts Two expansion cohorts are planned, investigating the efficacy and safety in pre-specified populations of interest.
Patients will be treated at the RP2D; 25 evaluable patients are needed in each cohort, to account for possible non evaluable patients, up to 28 patients will be enrolled in each cohort.
Patients enrolled in the phase I part at the RP2D and fulfilling the eligibility criteria of one of the expansion cohorts will be counted in those 25 evaluable patients. Receives: Drug: PLX038 + Tuvusertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation step : Dose limiting toxicities (DLTs)
Dose limiting toxicities (DLTs) experienced during 21 days from the first IV infusion of PLX038 + Tuvusertib
Measured: 21 days
Expansion cohorts : Best tumor response
Best tumor response (defined as PR or CR in the first 6 months of treatment, assessed by investigators per RECIST v1.1 criteria)
Measured: 6 months
Expansion cohorts : Serious Adverse Events (SAEs)
Serious Adverse Events (SAEs) according to NCI CTCAE v5.0 by grade and their relationship to PLX038 + Tuvusertib.
Measured: Until 30 days after the last dose of IMP (44 months + 30 days)
Expansion cohorts : Adverse Events (AEs)
Adverse Events (AEs) according to NCI CTCAE v5.0 by grade and their relationship to PLX038 + Tuvusertib.
Measured: Until 30 days after the last dose of IMP (44 months + 30 days)
Secondary outcomes (14)
Dose escalation step : Pharmacokinetics effect of PLX038 and Tuvusertib
Maximum Plasma Concentration effect of PLX038, SN38 and Tuvusertib
Measured: through study completion, an average of 44 months
Dose escalation step : Pharmacodynamics effect of PLX038 and Tuvusertib
Maximum Plasma Concentration effect of PLX038, SN38 and Tuvusertib
Measured: through study completion, an average of 44 months
Dose escalation step : objective response rate (ORR)
ORR defined as the percentage of patients with complete response (CR) or partial response (PR), as the best response measured at the disease assessmement after initiation of treament according to RECIST v1.1
Measured: through study completion, an average of 44 months
Dose escalation step : Time to response (TTR)
TTR calculated from the initiation of treatment to best tumour response (CR/PR)
Measured: through study completion, an average of 44 months
Dose escalation step : Duration of Response (DoR)
DoR defined as the time period from best tumour response to disease progression (according to RECIST v1.1)
Measured: through study completion, an average of 44 months
Dose escalation step : Progression free survival (PFS)
PFS measured from the inclusion in the study to the first documented progression (according to RECIST v1.1) or death from any cause.
Measured: through study completion, an average of 44 months
Expansion cohorts : Time to response (TTR)
TTR calculated from the initiation of treatment to best tumour response (CR/PR)
Measured: through study completion, an average of 44 months
Expansion cohorts : Duration of Response (DoR)
DoR defined as the time period from best tumour response to disease progression
Measured: through study completion, an average of 44 months
Expansion cohorts : Progression free survival (PFS)
PFS measured from the inclusion in the study to the first documented progression
Measured: through study completion, an average of 44 months
Expansion cohorts : Overall Survival (OS)
OS is defined as the time from inclusion to the event death.
Measured: through study completion, an average of 44 months
Expansion cohorts : Efficacy of PLX038 + Tuvusertib in pre-defined biomarker subgroups
Association between PLX038 + Tuvusertib efficacy and homologous recombination (HR) defect (assessed by HR genes mutational status and BCRAness phenotype), replication stress-related biomarkers such as SFLN11 expression, RB1 loss; genomic alterations in DDR genes
Measured: through study completion, an average of 44 months
Expansion cohorts : Pharmacokinetics effect of PLX038 and Tuvusertib
Maximum Plasma Concentration effect of PLX038, SN38 and Tuvusertib
Measured: through study completion, an average of 44 months
Expansion cohorts : Pharmacodynamics effect of PLX038 and Tuvusertib
Maximum Plasma Concentration effect of PLX038, SN38 and Tuvusertib
Measured: through study completion, an average of 44 months
Exploratory endpoints
Association between PLX038 + Tuvusertib efficacy and quantitative changes of blood biomarkers (e.g. ctDNA) during therapy.
Measured: through study completion, an average of 44 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start20 Jan 2025
- Primary completion24 Nov 2025
- Study completion24 Nov 2025
Why it stopped: Although no safety signal has been observed, given that the industrial development of tuvusertib has been halted regardless of the results, we see no scientific and ethical justification for continuing the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- ProLynx LLC, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337630
- Sponsor's protocol ID
- IC 2022-10
- Acronym
- POP-ART
- Status last verified
- Dec 2025
- First submitted
- 18 Mar 2024
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study on Tuvusertib (Oral ATR Inhibitor) in Combination With PLX038 (Topo1 Inhibitor) With Dose Expansion Cohorts in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06337630
- Acronym / sponsor ID
- POP-ART / IC 2022-10
- Conditions
- Solid Tumor
- Keywords
- Pretreated, Metastatic, Locally, Advanced triple negative breast, ATM Gene Mutation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Although no safety signal has been observed, given that the industrial development of tuvusertib has been halted regardless of the results, we see no scientific and ethical justification for continuing the study
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- ProLynx LLC, Merck Sharp & Dohme LLC
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types.
Detailed description
This is an open label, multi-centric phase I with, first, a dose escalation step using an adaptation of the Bayesian Optimal INterval (BOIN) drug-combination, followed by 2 dose expansion cohorts using the Simon 2-stage design.
Dose escalation step Dose escalation will be conducted on the grid defined by the 4 doses of PLX038 (800 mg/m², 1000 mg/m², 1300 mg/m² and 1700 mg/m² IV every 21 days D1=D22) and 3 doses of Tuvusertib (90 mg, 130 mg and 180 mg QD for 10 days from D3, D3-12). Premedication with anti-emetic agents is not required prior to the initial infusion, but may be used for an individual patient, as needed.
starting combination level is c1 (PLX038 800mg/m2 and Tuvusertib 90mg). Groups of 3 patients will be sequentially enrolled. One week between the enrollment of the 1st patient and the 2 following patients is mandatory at a new combination level. The decision to (de)-escalate one of the two agents depends on the outcome of all patients treated at the current combination.
Expansion cohorts Two expansion cohorts are planned, investigating the efficacy and safety in pre-specified populations of interest.
Patients will be treated at the RP2D; 25 evaluable patients are needed in each cohort, to account for possible non evaluable patients, up to 28 patients will be enrolled in each cohort.
Patients enrolled in the phase I part at the RP2D and fulfilling the eligibility criteria of one of the expansion cohorts will be counted in those 25 evaluable patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types.
| Arm | Type | Receives |
|---|---|---|
| Single arm: treatment with PLX038 and Tuvusertib | Experimental | Drug: PLX038 + TuvusertibDose escalation step Dose escalation will be conducted on the grid defined by the 4 doses of PLX038 (800 mg/m², 1000 mg/m², 1300 mg/m² and 1700 mg/m² IV every 21 days D1=D22) and 3 doses of Tuvusertib (90 mg, 130 mg and 180 mg QD for 10 days from D3, D3-12). Premedication with anti-emetic agents is not required prior to the initial infusion, but may be used for an individual patient, as needed. Expansion cohorts Two expansion cohorts are planned, investigating the efficacy and safety in pre-specified populations of interest. Patients will be treated at the RP2D; 25 evaluable patients are needed in each cohort, to account for possible non evaluable patients, up to 28 patients will be enrolled in each cohort. Patients enrolled in the phase I part at the RP2D and fulfilling the eligibility criteria of one of the expansion cohorts will be counted in those 25 evaluable patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Willing and able to comply with the protocol and provide written informed consent prior to study-specific screening procedures.
- Age ≥ 18 years.
- Locally advanced or metastatic solid cancer that is not amenable to curative treatment.
- Measurable disease (per RECIST version 1.1).
- Received a minimum of one and a maximum of six prior cytotoxic chemotherapy regimens for locally advanced or metastatic cancer.
Key exclusion criteria (22 listed)
- Patients who have had a last dose of IV chemotherapy within 21 days, last dose of oral cytotoxic chemotherapy, radiotherapy, biological therapy, or investigational therapy within 14 days prior to treatment start.
- Patients who have had any major surgery within 28 days prior to inclusion.
- Patients with chronic inflammatory bowel disease and/or bowel obstruction.
- Concomitant use of other agents for the treatment of cancer (except for LHRH agonist/antagonist) or any investigational agent(s).
- Brain metastases, unless local therapy was completed and use of corticosteroids for this indication discontinued for at least 3 weeks prior to inclusion. Signs or symptoms of brain metastases must be stable for at least 28 days prior to inclusion. No known progression of brain metastases (by imaging as assessed by RECIST version 1.1) can have occurred. Patients with leptomeningeal disease or meningeal carcinomatosis are excluded.
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 |
|---|---|---|
| PLX038 + TuvusertibDose escalation will be conducted on the grid defined by the 4 doses of PLX038 (800 mg/m², 1000 mg/m², 1300 mg/m² and 1700 mg/m² IV every 21 days D1=D22) and 3 doses of Tuvusertib (90 mg, 130 mg and 180 mg QD for 10 days from D3, D3-12). Premedication with anti-emetic agents is not required prior to the initial infusion, but may be used for an individual patient, as needed. All included patients will receive PLX038 + Tuvusertib until progression of disease, unacceptable toxicity, patient withdrawal of consent, investigator decision, lost to follow-up, death, patient non-compliance, or study termination by Sponsor. | Drug | Single arm: treatment with PLX038 and Tuvusertib |
Primary outcome
Dose escalation step : Dose limiting toxicities (DLTs)
Time frame: 21 days
Dose limiting toxicities (DLTs) experienced during 21 days from the first IV infusion of PLX038 + Tuvusertib
Expansion cohorts : Best tumor response
Time frame: 6 months
Best tumor response (defined as PR or CR in the first 6 months of treatment, assessed by investigators per RECIST v1.1 criteria)
Expansion cohorts : Serious Adverse Events (SAEs)
Time frame: Until 30 days after the last dose of IMP (44 months + 30 days)
Serious Adverse Events (SAEs) according to NCI CTCAE v5.0 by grade and their relationship to PLX038 + Tuvusertib.
Expansion cohorts : Adverse Events (AEs)
Time frame: Until 30 days after the last dose of IMP (44 months + 30 days)
Adverse Events (AEs) according to NCI CTCAE v5.0 by grade and their relationship to PLX038 + Tuvusertib.
14 secondary outcomes
Dose escalation step : Pharmacokinetics effect of PLX038 and Tuvusertib
Time frame: through study completion, an average of 44 months
Dose escalation step : Pharmacodynamics effect of PLX038 and Tuvusertib
Time frame: through study completion, an average of 44 months
Dose escalation step : objective response rate (ORR)
Time frame: through study completion, an average of 44 months
Dose escalation step : Time to response (TTR)
Time frame: through study completion, an average of 44 months
Dose escalation step : Duration of Response (DoR)
Time frame: through study completion, an average of 44 months
Dose escalation step : Progression free survival (PFS)
Time frame: through study completion, an average of 44 months
Expansion cohorts : Time to response (TTR)
Time frame: through study completion, an average of 44 months
Expansion cohorts : Duration of Response (DoR)
Time frame: through study completion, an average of 44 months
Expansion cohorts : Progression free survival (PFS)
Time frame: through study completion, an average of 44 months
Expansion cohorts : Overall Survival (OS)
Time frame: through study completion, an average of 44 months
Expansion cohorts : Efficacy of PLX038 + Tuvusertib in pre-defined biomarker subgroups
Time frame: through study completion, an average of 44 months
Expansion cohorts : Pharmacokinetics effect of PLX038 and Tuvusertib
Time frame: through study completion, an average of 44 months
Expansion cohorts : Pharmacodynamics effect of PLX038 and Tuvusertib
Time frame: through study completion, an average of 44 months
Exploratory endpoints
Time frame: through study completion, an average of 44 months
Results and safety
The study was stopped early (reason given: Although no safety signal has been observed, given that the industrial development of tuvusertib has been halted regardless of the results, we see no scientific and ethical justification for continuing the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PLX038 + Tuvusertib in people with Solid Tumor, run by Institut Curie at 2 sites in France.
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 12 inclusion and 22 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: stopped early, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Although no safety signal has been observed, given that the industrial development of tuvusertib has been halted regardless of the results, we see no scientific and ethical justification for continuing the study). Results are not available in the source record.
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?
Dose escalation step : Dose limiting toxicities (DLTs) (time frame: 21 days). The study lists 4 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 2 Jan 2026.