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Record W4379468067 · doi:10.1038/s41591-023-02399-0

Camonsertib in DNA damage response-deficient advanced solid tumors: phase 1 trial results

2023· article· en· W4379468067 on OpenAlexaff
Timothy A. Yap, Elisa Fontana, Elizabeth K. Lee, David R. Spigel, Martin Højgaard, Stéphanie Lheureux, Niharika B. Mettu, Benedito A. Carneiro, Louise Carter, Ruth Plummer, Gregory M. Coté, Funda Meric‐Bernstam, Joseph O’Connell, Joseph D. Schonhoft, Marisa J. Wainszelbaum, Adrian J. Fretland, Peter Manley, Yi Xu, Danielle Ulanet, Victoria Rimkunas, Mike Zinda, María Koehler, Ian M. Silverman, Jorge S. Reis‐Filho, Ezra Y. Rosen

Bibliographic record

VenueNature Medicine · 2023
Typearticle
Languageen
FieldBiochemistry, Genetics and Molecular Biology
TopicDNA Repair Mechanisms
Canadian institutionsPrincess Margaret Cancer Centre
FundersDuke Cancer InstituteChugai PharmaceuticalGenentechMenarini GroupPharmaMarAstellas PharmaEisaiSpringworks TherapeuticsSeagenMereo BioPharmaMacroGenicsSilverback TherapeuticsActuate TherapeuticsLoxo OncologyAstex PharmaceuticalsInvitaeAstraZenecaNovocureJazz PharmaceuticalsMerck KGaAUniversity of Texas MD Anderson Cancer CenterPuma BiotechnologyRegeneron PharmaceuticalsSpectrum PharmaceuticalsMersana TherapeuticsKaryopharm TherapeuticsPfizerIncyteF. Hoffmann-La RocheSanofiDaiichi Sankyo EuropeNational Cancer InstituteServierFoghorn TherapeuticsSamsungBristol-Myers SquibbAmgenMemorial Sloan-Kettering Cancer CenterMassachusetts General HospitalGlaxoSmithKline
KeywordsMedicinePharmacodynamicsPharmacokineticsCancerAtaxia-telangiectasiaCancer researchOncologyClinical trialInternal medicineDNA damagePharmacologyBiologyDNAGenetics

Abstract

fetched live from OpenAlex

Abstract Predictive biomarkers of response are essential to effectively guide targeted cancer treatment. Ataxia telangiectasia and Rad3-related kinase inhibitors (ATRi) have been shown to be synthetic lethal with loss of function (LOF) of ataxia telangiectasia-mutated (ATM) kinase, and preclinical studies have identified ATRi-sensitizing alterations in other DNA damage response (DDR) genes. Here we report the results from module 1 of an ongoing phase 1 trial of the ATRi camonsertib (RP-3500) in 120 patients with advanced solid tumors harboring LOF alterations in DDR genes, predicted by chemogenomic CRISPR screens to sensitize tumors to ATRi. Primary objectives were to determine safety and propose a recommended phase 2 dose (RP2D). Secondary objectives were to assess preliminary anti-tumor activity, to characterize camonsertib pharmacokinetics and relationship with pharmacodynamic biomarkers and to evaluate methods for detecting ATRi-sensitizing biomarkers. Camonsertib was well tolerated; anemia was the most common drug-related toxicity (32% grade 3). Preliminary RP2D was 160 mg weekly on days 1–3. Overall clinical response, clinical benefit and molecular response rates across tumor and molecular subtypes in patients who received biologically effective doses of camonsertib (>100 mg d −1 ) were 13% (13/99), 43% (43/99) and 43% (27/63), respectively. Clinical benefit was highest in ovarian cancer, in tumors with biallelic LOF alterations and in patients with molecular responses. ClinicalTrials.gov registration: NCT04497116 .

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.004
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Bench or experimental · Consensus signal: Bench or experimental
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.067
Threshold uncertainty score0.751

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0020.004
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.011
GPT teacher head0.337
Teacher spread0.326 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designBench or experimental
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations102
Published2023
Admission routes1
Has abstractyes

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