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    DRUG:

    camonsertib (RP-3500)

    i
    Other names: RP-3500, RG6526, RG 6526, RG-6526, RP 3500, RP3500
    Associations

    News

    Trials
    Company:
    Repare Therap
    Drug class:
    ATR inhibitor
    Related drugs:
    Associations

    News

    Trials
    10d
    CORONADO CLL: RP-3500 and Olaparib in DNA Damage Repair Pathway Deficient Relapsed/Refractory Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P1/2, N=5, Terminated, University of Utah | N=39 --> 5 | Trial completion date: Aug 2027 --> Oct 2024 | Recruiting --> Terminated; This study was terminated due to sponsor de-activation of all programs associated with RP-3500 (camonsertib).
    Enrollment change • Trial completion date • Trial termination
    |
    TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • SF3B1 (Splicing Factor 3b Subunit 1) • CCND1 (Cyclin D1) • CD5 (CD5 Molecule) • POT1 (Protection of telomeres 1) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    TP53 mutation • ATM mutation • Chr t(11;14) • SF3B1 mutation
    |
    Lynparza (olaparib) • camonsertib (RP-3500)
    27d
    Genomic biomarkers predict response to combined ATR inhibition and radiotherapy. (PubMed, Clin Cancer Res)
    A recent study reports the novel ATR kinase inhibitor, RP-3500, synergizes with radiation to control Atm-/- tumors in vivo. RP-3500 did not radiosensitize wild-type or Brca-1 deficient tumors, highlighting the need for a genotype-tailored approach.
    Journal • BRCA Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA (Breast cancer early onset)
    |
    camonsertib (RP-3500)
    3ms
    ATTACC: Study of RP-3500 (Camonsertib) With Niraparib or Olaparib in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=196, Active, not recruiting, Repare Therapeutics | Recruiting --> Active, not recruiting | Phase classification: P1b/2 --> P1/2
    Enrollment closed • Phase classification • Metastases
    |
    Lynparza (olaparib) • Zejula (niraparib) • camonsertib (RP-3500)
    3ms
    Genotype-Directed Synthetic Cytotoxicity of ATR Inhibition with Radiotherapy. (PubMed, Clin Cancer Res)
    We investigated the synergistic potential of the ATR inhibitor (ATRi) RP-3500 and RT in two Atm-null and isogenic murine models, both in vitro and in vivo...Lastly, early results from our clinical trial showed complete responses in patients. Genotype-directed radiosensitization with ATRi and RT can unleash significant therapeutic benefit and could represent a novel approach to develop more effective combinatorial synthetic cytotoxic RT-based treatments.
    Journal • BRCA Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • ATM (ATM serine/threonine kinase)
    |
    camonsertib (RP-3500)
    5ms
    TRESR: Study of RP-3500, Camonsertib, in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=285, Recruiting, Repare Therapeutics | Active, not recruiting --> Recruiting | Trial completion date: Feb 2025 --> Dec 2025 | Trial primary completion date: Mar 2024 --> Jul 2025
    Enrollment open • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    gemcitabine • Talzenna (talazoparib) • camonsertib (RP-3500)
    5ms
    Morpheus Lung: A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (clinicaltrials.gov)
    P1/2, N=675, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Jun 2026 --> Sep 2025 | Recruiting --> Active, not recruiting | Trial completion date: Sep 2027 --> Nov 2026
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • docetaxel • Cotellic (cobimetinib) • pemetrexed • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • Repatha (evolocumab) • camonsertib (RP-3500) • cibisatamab (RG7802) • ciforadenant (CPI-444) • zanzalintinib (XL092)
    7ms
    MYTHIC: Study of RP-6306 Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=364, Recruiting, Repare Therapeutics | N=180 --> 364
    Enrollment change • Combination therapy • Metastases
    |
    lunresertib (RP-6306) • Debio 0123 • camonsertib (RP-3500)
    9ms
    Morpheus Lung: A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (clinicaltrials.gov)
    P1/2, N=675, Recruiting, Hoffmann-La Roche | N=470 --> 675 | Trial completion date: Nov 2026 --> Sep 2027 | Trial primary completion date: Aug 2025 --> Jun 2026
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • docetaxel • Cotellic (cobimetinib) • pemetrexed • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • camonsertib (RP-3500) • cibisatamab (RG7802) • ciforadenant (CPI-444) • zanzalintinib (XL092)
    9ms
    CORONADO CLL: RP-3500 and Olaparib in DNA Damage Repair Pathway Deficient Relapsed/Refractory Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P1/2, N=39, Recruiting, University of Utah | Suspended --> Recruiting
    Enrollment open
    |
    TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • SF3B1 (Splicing Factor 3b Subunit 1) • CCND1 (Cyclin D1) • CD5 (CD5 Molecule) • POT1 (Protection of telomeres 1) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    TP53 mutation • ATM mutation • Chr t(11;14) • SF3B1 mutation
    |
    Lynparza (olaparib) • camonsertib (RP-3500)
    10ms
    MYTHIC: Study of RP-6306 Alone or in Combination With RP-3500 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=180, Recruiting, Repare Therapeutics | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Oct 2023 --> Jun 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    lunresertib (RP-6306) • camonsertib (RP-3500)
    11ms
    TRESR: Study of RP-3500, Camonsertib, in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=273, Active, not recruiting, Repare Therapeutics | Recruiting --> Active, not recruiting | N=451 --> 273 | Trial completion date: Mar 2024 --> Feb 2025
    Enrollment closed • Enrollment change • Trial completion date • Combination therapy • Metastases
    |
    gemcitabine • Talzenna (talazoparib) • camonsertib (RP-3500)
    1year
    ATTACC: Study of RP-3500 (Camonsertib) With Niraparib or Olaparib in Advanced Solid Tumors (clinicaltrials.gov)
    P1b/2, N=196, Recruiting, Repare Therapeutics | N=108 --> 196 | Trial completion date: Nov 2023 --> Dec 2025 | Trial primary completion date: Oct 2023 --> Mar 2025
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    Lynparza (olaparib) • Zejula (niraparib) • camonsertib (RP-3500)
    1year
    Coronado CLL: A Phase Ib/II Trial of Combination Rp-3500 and Olaparib in DNA Damage Repair Pathway Deficient Relapsed/Refractory Chronic Lymphocytic Leukemia (ASH 2023)
    With a planned 24 evaluable pts in phase II, the target ORR will be 60%, which was selected due to a recent phase I/II study of pirtobrutinib enrolling a similar CLL pt population demonstrating an ORR of the drug ~63%. ORR will be summarized by the observed proportion and an exact one-sided 95% confidence interval (Clopper-Pearson method). With 24 evaluable pts, the lower bound of the confidence interval will be approximately 17-20% below the observed proportion for observed ORR near 60%, which is an acceptable level of precision in a dose expansion cohort.
    P1/2 data • BRCA Biomarker • PARP Biomarker • IO biomarker
    |
    TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • SF3B1 (Splicing Factor 3b Subunit 1) • POT1 (Protection of telomeres 1)
    |
    TP53 mutation • BRCA2 mutation • BRCA1 mutation • ATM mutation • Chr del(11q) • SF3B1 mutation • Chr del(17p) + Chr del(11q)
    |
    Lynparza (olaparib) • Jaypirca (pirtobrutinib) • camonsertib (RP-3500)
    1year
    MYTHIC: First-in-human (FIH) biomarker-driven phase I trial of PKMYT1 inhibitor lunresertib (lunre) alone and with ATR inhibitor camonsertib (cam) in solid tumors with CCNE1 amplification or deleterious alterations in FBXW7 or PPP2R1. (AACR-NCI-EORTC 2023)
    No abstract available
    P1 data
    |
    CCNE1 (Cyclin E1) • FBXW7 (F-Box And WD Repeat Domain Containing 7) • PKMYT1 (Protein Kinase Membrane Associated Tyrosine/Threonine 1)
    |
    CCNE1 amplification
    |
    lunresertib (RP-6306) • camonsertib (RP-3500)
    1year
    MYTHIC: First-in-human (FIH) biomarker-driven phase I trial of PKMYT1 inhibitor lunresertib (lunre) alone and with ATR inhibitor camonsertib (cam) in solid tumors with CCNE1 amplification or deleterious alterations in FBXW7 or PPP2R1A* (AACR-NCI-EORTC 2023)
    No abstract available
    P1 data
    |
    CCNE1 (Cyclin E1) • FBXW7 (F-Box And WD Repeat Domain Containing 7) • PKMYT1 (Protein Kinase Membrane Associated Tyrosine/Threonine 1) • PPP2R1A (Protein Phosphatase 2 Scaffold Subunit Aalpha)
    |
    CCNE1 amplification
    |
    lunresertib (RP-6306) • camonsertib (RP-3500)
    1year
    CORONADO CLL: RP-3500 and Olaparib in DNA Damage Repair Pathway Deficient Relapsed/Refractory Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P1/2, N=39, Suspended, University of Utah | Recruiting --> Suspended
    Trial suspension
    |
    TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • SF3B1 (Splicing Factor 3b Subunit 1) • CCND1 (Cyclin D1) • CD5 (CD5 Molecule) • POT1 (Protection of telomeres 1) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    TP53 mutation • ATM mutation • Chr t(11;14) • SF3B1 mutation
    |
    Lynparza (olaparib) • camonsertib (RP-3500)
    over1year
    Morpheus Lung: A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (clinicaltrials.gov)
    P1/2, N=470, Recruiting, Hoffmann-La Roche | Trial completion date: Aug 2025 --> Nov 2026 | Trial primary completion date: Apr 2024 --> Aug 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • docetaxel • Cotellic (cobimetinib) • pemetrexed • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • Repatha (evolocumab) • camonsertib (RP-3500) • cibisatamab (RG7802) • ciforadenant (CPI-444) • zanzalintinib (XL092)
    over1year
    Camonsertib in DNA damage response-deficient advanced solid tumors: phase 1 trial results. (PubMed, Nat Med)
    Clinical benefit was highest in ovarian cancer, in tumors with biallelic LOF alterations and in patients with molecular responses. ClinicalTrials.gov registration: NCT04497116 .
    P1 data • Journal • Metastases
    |
    ATR (Ataxia telangiectasia and Rad3-related protein)
    |
    camonsertib (RP-3500)
    over1year
    MYTHIC: Study of RP-6306 Alone or in Combination With RP-3500 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=180, Recruiting, Repare Therapeutics | N=120 --> 180 | Trial completion date: Apr 2024 --> Dec 2024
    Enrollment change • Trial completion date • Combination therapy • Metastases
    |
    CDK1 (Cyclin-dependent kinase 1)
    |
    lunresertib (RP-6306) • camonsertib (RP-3500)
    2years
    A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer (clinicaltrials.gov)
    P1/2, N=74, Recruiting, Memorial Sloan Kettering Cancer Center
    New P1/2 trial • Combination therapy • Metastases
    |
    ATM (ATM serine/threonine kinase)
    |
    ATM mutation • ATM deletion
    |
    camonsertib (RP-3500)
    2years
    CORONADO CLL: RP-3500 and Olaparib in DNA Damage Repair Pathway Deficient Relapsed/Refractory Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P1/2, N=39, Recruiting, University of Utah | Not yet recruiting --> Recruiting
    Enrollment open
    |
    TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule) • SF3B1 (Splicing Factor 3b Subunit 1) • CCND1 (Cyclin D1) • CD5 (CD5 Molecule) • POT1 (Protection of telomeres 1) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    TP53 mutation • ATM mutation • Chr t(11;14) • SF3B1 mutation
    |
    Lynparza (olaparib) • camonsertib (RP-3500)
    2years
    CDK12 loss leads to replication stress and sensitivity to combinations of the ATR inhibitor camonsertib (RP-3500) with PARP inhibitors (AACR-NCI-EORTC 2022)
    Conclusions The work reports on novel evidence supporting the hypothesis that CDK12 LOF does not lead to HRD, but rather causes aberrant DNA replication origin licensing. Our findings suggest that CDK12 biallelic LOF mutations may result in a therapeutic vulnerability to ATRi/PARPi, potentially leading to a new therapeutic approach to tumors with CDK12 LOF.
    PARP Biomarker
    |
    CDK12 (Cyclin dependent kinase 12) • CDT1 (Chromatin Licensing And DNA Replication Factor 1)
    |
    camonsertib (RP-3500)
    over2years
    CORONADO CLL: RP-3500 and Olaparib in DNA Damage Repair Pathway Deficient Relapsed/Refractory Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P1/2, N=39, Not yet recruiting, University of Utah
    New P1/2 trial
    |
    TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule) • SF3B1 (Splicing Factor 3b Subunit 1) • CCND1 (Cyclin D1) • CD5 (CD5 Molecule) • POT1 (Protection of telomeres 1) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    TP53 mutation • ATM mutation • SF3B1 mutation
    |
    Lynparza (olaparib) • camonsertib (RP-3500)
    over2years
    MYTHIC: Study of RP-6306 Alone or in Combination With RP-3500 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=120, Recruiting, Repare Therapeutics | N=60 --> 120 | Trial completion date: Jun 2023 --> Apr 2024 | Trial primary completion date: Apr 2023 --> Oct 2023
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    CDK1 (Cyclin-dependent kinase 1)
    |
    lunresertib (RP-6306) • camonsertib (RP-3500)
    over2years
    Circulating tumor DNA (ctDNA) determinants of improved outcomes in patients (pts) with advanced solid tumors receiving the ataxia telangiectasia and Rad3-related inhibitor (ATRi), RP-3500, in the phase 1/2a TRESR trial (NCT04497116). (ASCO 2022)
    ctDNA testing is a reliable method to detect DNA damage repair LOF alterations but is limited to alterations and genes/exons covered by the ctDNA test. CH alterations are frequent, especially for ATM, thus matched normal analysis is preferred. Changes in ctDNA as early as 3 wks were associated with improved outcomes and may be useful for evaluating drug activity in heterogenous tumors outside of traditional efficacy endpoints.
    P1/2 data • Clinical • PARP Biomarker • BRCA Biomarker • Circulating tumor DNA
    |
    KRAS (KRAS proto-oncogene GTPase) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PALB2 (Partner and localizer of BRCA2) • CDK12 (Cyclin dependent kinase 12) • MUC16 (Mucin 16, Cell Surface Associated) • ATR (Ataxia telangiectasia and Rad3-related protein) • RAD51C (RAD51 paralog C)
    |
    KRAS mutation • BRCA1 mutation • PALB2 mutation
    |
    Guardant360® CDx • Tempus xF Assay • Tempus xF+ Panel
    |
    camonsertib (RP-3500)
    over2years
    Genomic and pathologic determinants of response to RP-3500, an ataxia telangiectasia and Rad3-related inhibitor (ATRi), in patients (pts) with DNA damage repair (DDR) loss-of-function (LOF) mutant tumors in the Phase 1/2 TRESR trial (AACR 2022)
    RP-3500 has clinical activity across STEP2 genotypes including those pretreated with PARPi and with BRCA1 reversions. IHC is an imperfect surrogate for ATM zygosity. ATM alterations originating from clonal hematopoiesis of indeterminate potential (CHIP) can be misdiagnosed as tumor derived.
    Clinical • P1/2 data • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • PALB2 (Partner and localizer of BRCA2) • CDK12 (Cyclin dependent kinase 12) • MUC16 (Mucin 16, Cell Surface Associated) • ATR (Ataxia telangiectasia and Rad3-related protein) • SETD2 (SET Domain Containing 2, Histone Lysine Methyltransferase) • RAD51C (RAD51 paralog C) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin))
    |
    ATM mutation • NBN mutation
    |
    camonsertib (RP-3500)
    almost3years
    TRESR: Study of RP-3500 in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=457, Recruiting, Repare Therapeutics | N=239 --> 457 | Trial completion date: Jul 2022 --> Mar 2024 | Trial primary completion date: May 2022 --> Jan 2024
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    gemcitabine • Talzenna (talazoparib) • camonsertib (RP-3500)
    3years
    [VIRTUAL] First-in-Human biomarker-driven phase I TRESR trial of ataxia telangiectasia and Rad3-related inhibitor (ATRi) RP-3500 in patients (pts) with advanced solid tumors harboring synthetic lethal (SL) genomic alterations (AACR-NCI-EORTC 2021)
    No abstract available
    Clinical • P1 data • Synthetic lethality
    |
    ATR (Ataxia telangiectasia and Rad3-related protein)
    |
    camonsertib (RP-3500)