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Trials |  |
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- | luvixasertib (CFI-402257) / Treadwell Therap
Journal: TTK Inhibition Alleviates Postinjury Neointimal Formation and Atherosclerosis. (Pubmed Central) - Feb 10, 2025
Notably, oral administration of the TTK inhibitor CFI-402257 mitigated neointimal formation without impairing reendothelialization and reduced atherosclerotic lesions in ApoE-/- mice without altering lipid levels. These findings suggest that targeting TTK, through inhibitors or alternative strategies, represents a promising approach to simultaneously prevent postinjury restenosis and treat atherosclerosis.
- Venclexta (venetoclax) / Roche, AbbVie
Inhibition of Threonine Tyrosine Kinase Suppressed TP53-mutated Acute Myeloid Leukaemia Via Synergism with Venetoclax and Activation of the Cgas-Sting Pathway (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_5263;
There was demonstrable synergism with venetoclax. Our results have provided important leads for further mechanistic and clinical studies.
- | luvixasertib (CFI-402257) / Treadwell Therap
Phase classification, Trial completion date, Combination therapy, Metastases: CCTG IND.236: CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - Jun 25, 2024
P1/2, N=37, Active, not recruiting, Sponsor: Canadian Cancer Trials Group
Our results have provided important leads for further mechanistic and clinical studies. Phase classification: P2 --> P1/2 | Trial completion date: Dec 2023 --> Dec 2024
- CFI-402257 / Treadwell Therap
Spindle assembly checkpoint as a therapeutic target for TP53-mutated myeloid neoplasms (Section 22) - Mar 5, 2024 - Abstract #AACR2024AACR_5284;
The efficacy of TTKi CFI-402257 (AbMole) was tested using cell viability, apoptosis, and colony-forming unit (CFU) assays using the standard protocol...TTKi induced preferential and dose-dependent inhibition of viability and cell proliferation potential in TP53mut MN compared to healthy donor cells, implying a therapeutic window. Further pre-clinical and clinical studies are indicated to evaluate SAC inhibition as a therapeutic strategy for TP53mut MN.
- | luvixasertib (CFI-402257) / Treadwell Therap
Trial completion date, Trial primary completion date, Combination therapy, Metastases: TWT-203: CFI-402257, a Potent and Selective TTK Inhibitor, in Solid Tumors and With Fulvestrant in Breast Cancer (clinicaltrials.gov) - Dec 31, 2023
P1/2, N=44, Recruiting, Sponsor: Treadwell Therapeutics, Inc
- CFI-402257 / Treadwell Therap
TWT-203: PHASE 1b/2 STUDY OF CFI-402257 AS MONOTHERAPY IN ADVANCED SOLID TUMORS AND IN COMBINATION WITH FULVESTRANT IN PATIENTS WITH ER+/HER2- ADVANCED BREAST CANCER AFTER PROGRESSION ON PRIOR CDK4/6 INHIBITORS AND ENDOCRINE THERAPY (Hall 2-3) - Nov 4, 2023 - Abstract #SABCS2023SABCS_780;
P1
It is well tolerated with manageable TEAEs, no dose limiting or treatment limiting toxicities, and no treatment related deaths. Dose expansion in the patient population of interest will commence.
- BID upregulation associates with sensitivity to TTK inhibitors in tumor cell lines. (LEVEL 2, EXHIBIT HALL D) - Sep 16, 2023 - Abstract #AACRNCIEORTC2023AACR_NCI_EORTC_501;
- | lunresertib (RP-6306) / Repare Therap, camonsertib (RP-3500) / Repare Therap, Zejula (niraparib) / GSK, J&J
Trial initiation date, Liquid biopsy: Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer (clinicaltrials.gov) - Aug 4, 2023
P2, N=484, Recruiting, Sponsor: Canadian Cancer Trials Group
Dose expansion in the patient population of interest will commence. Initiation date: Jan 2023 --> Jun 2023
- | luvixasertib (CFI-402257) / Treadwell Therap
Trial primary completion date, Combination therapy, Metastases: CCTG IND.236: CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - Jun 1, 2023
P2, N=37, Active, not recruiting, Sponsor: Canadian Cancer Trials Group
Initiation date: Jan 2023 --> Jun 2023 Trial primary completion date: Jun 2023 --> Nov 2022
- CFI-402257 / Treadwell Therap
Glioblastoma stem-like cells are resistant to the negative effects of increased aneuploidy on in vitro survival and radiosensitivity (Section 3; Poster Board #13) - Mar 14, 2023 - Abstract #AACR2023AACR_5392;
This increase was induced by treatment with CFI-402257, a selective inhibitor of the mitotic kinase TTK, which plays a key role in spindle-assembly checkpoint (SAC) regulation...Overall, these results suggest that GSCs have an enhanced ability to tolerate the negative consequences of aneuploidy on survival as well as on radiosensitivity. Such aneuploid tolerance may provide a mechanism through which GBMs exploit karyotype diversity to survive under harsh environmental conditions and after treatment.
- | lunresertib (RP-6306) / Repare Therap, camonsertib (RP-3500) / Repare Therap, Zejula (niraparib) / GSK, J&J
Enrollment open, Liquid biopsy: Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer (clinicaltrials.gov) - Feb 8, 2023
P2, N=484, Recruiting, Sponsor: Canadian Cancer Trials Group
Such aneuploid tolerance may provide a mechanism through which GBMs exploit karyotype diversity to survive under harsh environmental conditions and after treatment. Not yet recruiting --> Recruiting
- | luvixasertib (CFI-402257) / Treadwell Therap
Trial completion date, Trial primary completion date, Combination therapy, Metastases: CCTG IND.236: CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - Jan 31, 2023
P2, N=37, Active, not recruiting, Sponsor: Canadian Cancer Trials Group
Not yet recruiting --> Recruiting Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Jun 2023
- ||||| CFI-402257 / Treadwell Therap
Fast track designation, FDA event: Treadwell Therapeutics Announces Fast Track Designation Granted by the FDA to CFI-402257 for the Treatment of ER+/HER2- Breast Cancer https://t.co/qsFyk6Rm2g (Twitter) - Jan 10, 2023
- | lunresertib (RP-6306) / Repare Therap, camonsertib (RP-3500) / Repare Therap, Zejula (niraparib) / GSK, J&J
New P2 trial, Liquid biopsy: Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer (clinicaltrials.gov) - Nov 1, 2022
P2, N=484, Not yet recruiting, Sponsor: Canadian Cancer Trials Group
- | luvixasertib (CFI-402257) / Treadwell Therap
Trial primary completion date, Combination therapy, Metastases: CCTG IND.236: CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - Oct 10, 2022
P2, N=37, Active, not recruiting, Sponsor: Canadian Cancer Trials Group
Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Jun 2023 Trial primary completion date: Aug 2022 --> Dec 2022
- CFI-402257 / Treadwell Therap
An update to a Phase I trial of CFI-402257, an oral TTK inhibitor, in patients with advanced solid tumors with HER2-negative breast cancer expansion cohorts (Hall 1) - Oct 10, 2022 - Abstract #SABCS2022SABCS_1575;
Efficacy signals are emerging with pts in the combo cohort demonstrating anti-tumor activity. Additional efficacy will be updated at the time of the presentation.
- CFI-402257 / Treadwell Therap
CCTG IND.236: A Phase 1b trial of combined CFI-402257 and weekly paclitaxel in patients with HER2-negative (HER2-) advanced breast cancer (aBC) (Hall 1) - Oct 10, 2022 - Abstract #SABCS2022SABCS_907;
DL3 (168mg) was selected as RP2D. Phase 2 ORR and CBR was 5.9% and 58.8%, respectively; during Phase 2, the 17 evaluable patients from stage 1 did not meet the pre-specified threshold for anti-tumor activity to proceed to stage 2 and the trial was closed to accrual on April 7, 2022.
- | CFI-402257 / Treadwell Therap
Journal: The spindle assembly checkpoint is a therapeutic vulnerability of CDK4/6 inhibitor-resistant ER breast cancer with mitotic aberrations. (Pubmed Central) - Sep 14, 2022
In these models, inhibition of TTK with CFI-402257 induces premature chromosome segregation, leading to excessive mitotic segregation errors, DNA damage, and cell death. These findings nominate the TTK inhibitor CFI-402257 as a therapeutic strategy for a defined subset of ER breast cancer patients who develop resistance to CDK4/6i.
- | CFI-402257 / Treadwell Therap
Journal: CFI-402257, a TTK inhibitor, effectively suppresses hepatocellular carcinoma. (Pubmed Central) - Aug 2, 2022
Further, CFI-402257 improved survival in HCC-bearing mice treated with anti-PD-1, suggesting the possibility of combination treatment with immune checkpoint inhibitors in HCC patients. In summary, our study characterized CFI-402257 as a potential therapeutic for HCC, both used as a single agent and in combination therapy.
- || luvixasertib (CFI-402257) / Treadwell Therap
Enrollment open, Combination therapy, Metastases: TWT-203: CFI-402257, a Potent and Selective TTK Inhibitor, in Solid Tumors and With Fulvestrant in Breast Cancer (clinicaltrials.gov) - Jul 29, 2022
P1/2, N=44, Recruiting, Sponsor: Treadwell Therapeutics, Inc
In summary, our study characterized CFI-402257 as a potential therapeutic for HCC, both used as a single agent and in combination therapy. Not yet recruiting --> Recruiting
- | temozolomide / Generic mfg.
Journal: TTK Protein Kinase promotes temozolomide resistance through inducing autophagy in glioblastoma. (Pubmed Central) - Jul 27, 2022
We demonstrated that TTK promotes the TMZ resistance of GBM cells by inducing autophagy in vitro and in vivo. The use of a TTK inhibitor in combination with TMZ might help to overcome TMZ resistance and improve therapy efficiency in GBM.
- | luvixasertib (CFI-402257) / Treadwell Therap
Trial completion date, Trial primary completion date, Combination therapy, Metastases: CCTG IND.236: CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - Jun 14, 2022
P2, N=37, Active, not recruiting, Sponsor: Canadian Cancer Trials Group
The use of a TTK inhibitor in combination with TMZ might help to overcome TMZ resistance and improve therapy efficiency in GBM. Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: Apr 2022 --> Aug 2022
- | luvixasertib (CFI-402257) / Treadwell Therap
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: CFI-402257-CL-001: A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - May 6, 2022
P1, N=52, Active, not recruiting, Sponsor: University Health Network, Toronto
Trial completion date: Aug 2022 --> Dec 2022 | Trial primary completion date: Apr 2022 --> Aug 2022 Recruiting --> Active, not recruiting | Trial completion date: Jan 2022 --> May 2027 | Trial primary completion date: Jan 2022 --> May 2027
- CFI-402257 / Treadwell Therap
TWT-203: Phase 1b/2 dose-confirming study of CFI-402257 as a single agent in advanced solid tumors and in combination with fulvestrant in patients with ER+/HER2- advanced breast cancer after disease progression on prior CDK4/6 and endocrine therapy. (Available On Demand; 492a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1209;
P1/2
Safety endpoints include incidence of treatment emergent adverse events. Exploratory objectives include characterization of protein and molecular alterations relevant to the cell cycle and CFI-402257 response.
- | luvixasertib (CFI-402257) / Treadwell Therap
Enrollment closed, Enrollment change, Combination therapy, Metastases: CCTG IND.236: CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - Apr 8, 2022
P2, N=37, Active, not recruiting, Sponsor: Canadian Cancer Trials Group
Exploratory objectives include characterization of protein and molecular alterations relevant to the cell cycle and CFI-402257 response. Recruiting --> Active, not recruiting | N=55 --> 37
- BAL0891 / Basilea
BAL0891: A novel, small molecule, dual TTK/PLK1 mitotic checkpoint inhibitor (MCI) that drives aberrant tumor cell division (E-Poster Website) - Mar 9, 2022 - Abstract #AACR2022AACR_7279;
In tumor cells, prolonged effects on TTK and transient effects on PLK1 contribute to rapid SAC disruption and aberrant mitotic exit. This is associated with potent anti-proliferative activity in diverse tumor lines.
- || luvixasertib (CFI-402257) / Treadwell Therap
New P1/2 trial, Combination therapy, Metastases: TWT-203: CFI-402257, a Potent and Selective TTK Inhibitor, in Solid Tumors and With Fulvestrant in Breast Cancer (clinicaltrials.gov) - Feb 23, 2022
P1/2, N=44, Not yet recruiting, Sponsor: Treadwell Therapeutics, Inc
- | luvixasertib (CFI-402257) / Treadwell Therap
Trial completion date, Combination therapy, Metastases: CCTG IND.236: CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - Jan 31, 2022
P2, N=55, Recruiting, Sponsor: Canadian Cancer Trials Group
This is associated with potent anti-proliferative activity in diverse tumor lines. Trial completion date: Mar 2022 --> Aug 2022
- | luvixasertib (CFI-402257) / Treadwell Therap
Trial primary completion date, Combination therapy, Metastases: CCTG IND.236: CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - Nov 9, 2021
P2, N=55, Recruiting, Sponsor: Canadian Cancer Trials Group
Trial completion date: Mar 2022 --> Aug 2022 Trial primary completion date: Sep 2021 --> Jan 2022
- CFI-402257 / Treadwell Therap
Phase I study of cfi-402257, an oral ttk inhibitor, in patients with advanced solid tumors with breast cancer expansion cohorts (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_575;
Enrollment in the expansion cohorts is ongoing and updated safety and efficacy data for the previously treated ER+/HER2- population will be presented at the time of the meeting. A multi-center phase II clinical trial is planned.
- | luvixasertib (CFI-402257) / Treadwell Therap
Trial completion date, Trial primary completion date, Combination therapy, Metastases: CCTG IND.236: CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - Feb 18, 2021
P2, N=55, Recruiting, Sponsor: Canadian Cancer Trials Group
A multi-center phase II clinical trial is planned. Trial completion date: Dec 2020 --> Mar 2022 | Trial primary completion date: Dec 2020 --> Sep 2021
- | luvixasertib (CFI-402257) / Treadwell Therap
Trial completion date, Trial primary completion date, Metastases: CFI-402257-CL-001: A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Sep 17, 2020
P1, N=52, Recruiting, Sponsor: University Health Network, Toronto
Trial completion date: Dec 2020 --> Mar 2022 | Trial primary completion date: Dec 2020 --> Sep 2021 Trial completion date: Jan 2021 --> Jan 2022 | Trial primary completion date: Jan 2021 --> Jan 2022
- | luvixasertib (CFI-402257) / Treadwell Therap
Trial primary completion date, Combination therapy, Metastases: CCTG IND.236: CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - Sep 3, 2020
P2, N=55, Recruiting, Sponsor: Canadian Cancer Trials Group
Trial completion date: Jan 2021 --> Jan 2022 | Trial primary completion date: Jan 2021 --> Jan 2022 Trial primary completion date: Jul 2020 --> Dec 2020
- | luvixasertib (CFI-402257) / Treadwell Therap
Trial completion date, Trial primary completion date, Metastases: CFI-402257-CL-001: A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - May 21, 2019
P1, N=48, Recruiting, Sponsor: University Health Network, Toronto
Trial primary completion date: Jul 2020 --> Dec 2020 Trial completion date: Jan 2019 --> Jan 2021 | Trial primary completion date: Jul 2018 --> Jan 2021
- | luvixasertib (CFI-402257) / Treadwell Therap
Enrollment open, Combination therapy, Metastases: CCTG IND.236: CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - Jan 17, 2019
P2, N=55, Recruiting, Sponsor: Canadian Cancer Trials Group
Trial completion date: Jan 2019 --> Jan 2021 | Trial primary completion date: Jul 2018 --> Jan 2021 Not yet recruiting --> Recruiting
- | luvixasertib (CFI-402257) / Treadwell Therap
New P2 trial, Combination therapy, Metastases: CCTG IND.236: CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer (clinicaltrials.gov) - Jun 26, 2018
P2, N=55, Not yet recruiting, Sponsor: Canadian Cancer Trials Group
- | luvixasertib (CFI-402257) / Treadwell Therap
Enrollment open, Trial initiation date, Metastases: CFI-402257-CL-001: A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Jun 20, 2017
P1, N=48, Recruiting, Sponsor: University Health Network, Toronto
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Jul 2016 --> Nov 2016
- luvixasertib (CFI-402257) / Treadwell Therap
New P1 trial, Metastases: CFI-402257-CL-001: A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Jun 9, 2016
P1, N=48, Not yet recruiting, Sponsor: University Health Network, Toronto