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0 Diseases |  |
2 Trials |
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2 Trials |  |
56 News |  |
- The clinical benefits of CDK 4/6 inhibitors and biomarker interactions on HR+/HER2- advanced breast cancer patients: an updated pairwise meta-analysis of randomized controlled trials and network meta-analysis (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_1738;
- ||||||| lerociclib (G1T38) / Walvax, Pepper Bio
Trial completion: LEONARDA-1: GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - Oct 10, 2024
P3, N=275, Completed, Sponsor: Genor Biopharma Co., Ltd.
Recruiting --> Completed
- lerociclib (G1T38) / Walvax, Pepper Bio
LEONARDA-2: Lerociclib plus letrozole versus placebo plus letrozole in HR+/HER2- advanced or metastatic breast cancer. (Hall A; Poster Bd #: 30) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2482;
P3
Lerociclib with letrozole had an excellent safety profile and significantly prolonged PFS in HR+/HER2- advanced or metastatic BC patients. This benefit was consistent across all clinically relevant subgroups, suggesting lerociclib as a viable first-line therapeutic option with a favorable benefit-risk balance.
- ||||| lerociclib (G1T38) / Walvax, Pepper Bio
Trial completion date, Trial termination, Metastases: A Study of Lerociclib in Participants With Advanced Breast Cancer (clinicaltrials.gov) - Dec 6, 2023
P2, N=100, Terminated, Sponsor: EQRx, Inc.
This benefit was consistent across all clinically relevant subgroups, suggesting lerociclib as a viable first-line therapeutic option with a favorable benefit-risk balance. Trial completion date: May 2026 --> Nov 2023 | Active, not recruiting --> Terminated; The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with lerociclib.
- | lerociclib (G1T38) / EQRx
Journal: CDK4/6 Inhibition With Lerociclib is a Potential Therapeutic Strategy for the Treatment of Pediatric Sarcomas. (Pubmed Central) - Nov 5, 2023
Inhibition of CDK 4/6 activity with lerociclib was efficacious in traditional 2D sarcoma cell culture as well as in 3D bioprints. Lerociclib holds promise and warrants further investigation as a novel therapeutic strategy for management of these heterogenous groups of tumors.
- || lerociclib (G1T38) / Walvax, Pepper Bio
Enrollment change, Trial withdrawal, Combination therapy, Metastases: Comparison of Letrozole With Lerociclib Versus Letrozole With Placebo Control in Patients With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrial Cancer (clinicaltrials.gov) - Sep 28, 2023
P3, N=0, Withdrawn, Sponsor: EQRx International, Inc.
Lerociclib holds promise and warrants further investigation as a novel therapeutic strategy for management of these heterogenous groups of tumors. N=320 --> 0 | Active, not recruiting --> Withdrawn
- ||||| lerociclib (G1T38) / Walvax, Pepper Bio
Enrollment closed, Combination therapy, Metastases: Comparison of Letrozole With Lerociclib Versus Letrozole With Placebo Control in Patients With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrial Cancer (clinicaltrials.gov) - Aug 15, 2023
P3, N=320, Active, not recruiting, Sponsor: EQRx International, Inc.
N=320 --> 0 | Active, not recruiting --> Withdrawn Recruiting --> Active, not recruiting
- || lerociclib (G1T38) / Walvax, Pepper Bio
Enrollment closed, Metastases: A Study of Lerociclib in Participants With Advanced Breast Cancer (clinicaltrials.gov) - Jul 21, 2023
P2, N=100, Active, not recruiting, Sponsor: EQRx, Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- ||||| lerociclib (G1T38) / EQRx, fulvestrant / Generic mfg.
Metastases: Lerociclib/Fulvestrant May Reduce Risk of Disease Progression in Advanced HR-Positive/HER2-Negative Breast Cancer https://t.co/TWzsHInxAr @ASCO #ASCO23 @glopesMD (Twitter) - May 31, 2023
- || lerociclib (G1T38) / Walvax
New P1 trial: A Study of [14C]GB491 in Male Healthy Subjects (clinicaltrials.gov) - May 16, 2023
P1, N=6, Completed, Sponsor: Genor Biopharma Co., Ltd.
- |||||||||| lerociclib (G1T38) / Walvax, Pepper Bio
New P3 trial, Combination therapy, Metastases: LEONARDA-2: A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer (clinicaltrials.gov) - May 8, 2023
P3, N=350, Recruiting, Sponsor: Genor Biopharma Co., Ltd.
- lerociclib (G1T38) / EQRx
LEONARDA-1: (Live Stream | Hall D2; Poster Bd # 238) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3331;
P3
Lerociclib at 150mg twice daily plus fulvestrant significantly improved PFS and ORR and demonstrated a favorable tolerable safety profile in pts with HR+ / HER2- endocrine-resistant advanced BC. Clinical trial information: NCT05054751.
- |||||| lerociclib (G1T38) / Walvax, Pepper Bio
Enrollment open, Combination therapy, Metastases: Comparison of Letrozole With Lerociclib Versus Letrozole With Placebo Control in Patients With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrial Cancer (clinicaltrials.gov) - Apr 25, 2023
P3, N=320, Recruiting, Sponsor: EQRx International, Inc.
Clinical trial information: NCT05054751. Not yet recruiting --> Recruiting
- || lerociclib (G1T38) / Walvax, Pepper Bio
Trial completion date, Trial primary completion date, Combination therapy, Metastases: G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - Feb 15, 2023
P1/2, N=102, Active, not recruiting, Sponsor: G1 Therapeutics, Inc.
Not yet recruiting --> Recruiting Trial completion date: Apr 2023 --> Oct 2023 | Trial primary completion date: Dec 2022 --> Jun 2023
- |||||||||| lerociclib (G1T38) / Walvax, Pepper Bio
New P3 trial, Combination therapy, Metastases: Comparison of Letrozole With Lerociclib Versus Letrozole With Placebo Control in Patients With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrial Cancer (clinicaltrials.gov) - Feb 6, 2023
P3, N=320, Not yet recruiting, Sponsor: EQRx International, Inc.
- || lerociclib (G1T38) / Walvax
Trial completion, Trial completion date, Combination therapy, Metastases: G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - Sep 22, 2022
P1b/2, N=30, Completed, Sponsor: G1 Therapeutics, Inc.
Trial completion date: Apr 2023 --> Oct 2023 | Trial primary completion date: Dec 2022 --> Jun 2023 Active, not recruiting --> Completed | Trial completion date: Apr 2023 --> Feb 2022
- lerociclib (G1T38) / G1 Therap, EQRx
Novel Technique for Preclinical Evaluation of Pediatric Sarcoma Therapeutics (SDCC - 2 - Upper) - Aug 21, 2022 - Abstract #ACSCLINCON2022ACS_CLINCON_2059;
We detected changes in cell viability after treatment with two different therapeutics employing two different methods. 3D bioprinting presents a novel technique for rapid evaluation of personalized targeted agents in the preclinical setting.
- || lerociclib (G1T38) / Walvax, Pepper Bio
Trial completion date, Trial primary completion date, Combination therapy, Metastases: G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - Aug 3, 2022
P1/2, N=102, Active, not recruiting, Sponsor: G1 Therapeutics, Inc.
3D bioprinting presents a novel technique for rapid evaluation of personalized targeted agents in the preclinical setting. Trial completion date: Sep 2022 --> Apr 2023 | Trial primary completion date: Jul 2022 --> Dec 2022
- |||||| lerociclib (G1T38) / Walvax, Pepper Bio
Enrollment open, Metastases: LEONARDA-1: GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - Jun 13, 2022
P3, N=270, Recruiting, Sponsor: Genor Biopharma Co., Ltd.
Trial completion date: Sep 2022 --> Apr 2023 | Trial primary completion date: Jul 2022 --> Dec 2022 Not yet recruiting --> Recruiting
- lerociclib (G1T38) / G1 Therap, EQRx
Lerociclib diminishes stemness in pediatric sarcoma cell lines. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_6338;
Treatment with lerociclib led to a decrease in mRNA abundance in known synovial sarcoma stem cell markers, a decrease in CD117 cell surface expression in osteosarcoma cells and decreased the ability of cells to form tumorspheres. These findings indicate lerociclib leads to decreased sarcoma cell stemness, which plays a key role in tumor progression and recurrence and should be further investigated for potential translation to the clinical setting.Treatment of osteosarcoma cell lines (OS) and metastatic synovial sarcoma (MSS) and metastatic epithelioid sarcoma (MES) PDXs with lerociclib led to decreased tumorsphere formation, reported as 1/(stem cell frequency) for each group.
- || lerociclib (G1T38) / Walvax, Pepper Bio
New P1 trial, Combination therapy, Metastases: A Phase Ib Study of GB491 Plus Letrozole in Patients With Advanced Breast Cancer (clinicaltrials.gov) - Apr 20, 2022
P1, N=10, Recruiting, Sponsor: Genor Biopharma Co., Ltd.
- || lerociclib (G1T38) / Walvax, Pepper Bio
Trial completion date, Trial primary completion date, Combination therapy, Metastases: G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - Jan 13, 2022
P1/2, N=102, Active, not recruiting, Sponsor: G1 Therapeutics, Inc.
These findings indicate lerociclib leads to decreased sarcoma cell stemness, which plays a key role in tumor progression and recurrence and should be further investigated for potential translation to the clinical setting.Treatment of osteosarcoma cell lines (OS) and metastatic synovial sarcoma (MSS) and metastatic epithelioid sarcoma (MES) PDXs with lerociclib led to decreased tumorsphere formation, reported as 1/(stem cell frequency) for each group. Trial completion date: Dec 2021 --> Sep 2022 | Trial primary completion date: Dec 2021 --> Jul 2022
- ||| lerociclib (G1T38) / Walvax, Pepper Bio
Enrollment open, Metastases: A Study of Lerociclib in Participants With Advanced Breast Cancer (clinicaltrials.gov) - Jan 12, 2022
P2, N=100, Recruiting, Sponsor: EQRx, Inc.
Trial completion date: Dec 2021 --> Sep 2022 | Trial primary completion date: Dec 2021 --> Jul 2022 Not yet recruiting --> Recruiting
- |||| lerociclib (G1T38) / Walvax, Pepper Bio
New P2 trial, Metastases: A Study of Lerociclib in Participants With Advanced Breast Cancer (clinicaltrials.gov) - Oct 19, 2021
P2, N=100, Not yet recruiting, Sponsor: EQRx, Inc.
- |||||||||| lerociclib (G1T38) / Walvax, Pepper Bio
New P3 trial, Metastases: LEONARDA-1: GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - Sep 23, 2021
P3, N=270, Not yet recruiting, Sponsor: Genor Biopharma Co., Ltd.
- | lerociclib (G1T38) / Walvax
Trial primary completion date, Combination therapy, Metastases: G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jun 4, 2021
P1b/2, N=30, Active, not recruiting, Sponsor: G1 Therapeutics, Inc.
Not yet recruiting --> Recruiting Trial primary completion date: Apr 2021 --> Dec 2021
- lerociclib (G1T38) / G1 Therap, EQRx
[VIRTUAL] EFFECT OF LEROCICLIB ON PEDIATRIC SARCOMAS () - Apr 14, 2021 - Abstract #ASPHO2021ASPHO_323;
Lerociclib treatment led to decreased cell proliferation, viability, migration and invasion and a halt in cell cycle progression in osteosarcoma and synovial sarcoma cells. These findings suggest lerociclib may be a promising therapeutic option for these difficult to treat tumors.
- lerociclib (G1T38) / G1 Therap, EQRx
[VIRTUAL] cfDNA analysis from phase I/II study of lerociclib (G1T38), a continuously dosed oral CDK4/6 inhibitor, with fulvestrant in HR+/HER2- advanced breast cancer patients () - Jan 17, 2021 - Abstract #YIR2021YIR_198;
- | rintodestrant (G1T48) / G1 Therapeutics, lerociclib (G1T38) / G1 Therap, EQRx
Preclinical, Journal: G1T48, an oral selective estrogen receptor degrader, and the CDK4/6 inhibitor lerociclib inhibit tumor growth in animal models of endocrine-resistant breast cancer. (Pubmed Central) - Dec 17, 2020
These findings suggest lerociclib may be a promising therapeutic option for these difficult to treat tumors. These data show that G1T48 has the potential to be an efficacious oral antineoplastic agent in ER-positive breast cancer.
- ||| lerociclib (G1T38) / G1 Therap, EQRx
Een 4e CDK4/6 remmer (uitgezaaide hormoongevoelig bk) wordt getest op zoek naar nog minder bijwerkingen zonder verlies van goede werking. Fase 1/2 studie dus nog héél pril: Lerociclib. @borstkanker #ESMO20 #bcsm studie in commentaar. (Twitter) - Sep 19, 2020
- || lerociclib (G1T38) / Walvax, Pepper Bio
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, Metastases: G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - Jul 27, 2020
P1/2, N=102, Active, not recruiting, Sponsor: G1 Therapeutics, Inc.
These data show that G1T48 has the potential to be an efficacious oral antineoplastic agent in ER-positive breast cancer. Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
- lerociclib (G1T38) / G1 Therap, EQRx, fulvestrant / Generic mfg.
[VIRTUAL] cfDNA analysis from phase I/II study of lerociclib (G1T38), a continuously dosed oral CDK4/6 inhibitor, with fulvestrant in HR+/HER2- advanced breast cancer patients (On-Demand) - Jul 24, 2020 - Abstract #ESMO2020ESMO_1589;
P1/2
Funding: G1 Therapeutics, Inc. Clinical trial identification: NCT02983071.
- ||| lerociclib (G1T38) / G1 Therap
EQRx inlicenses G1 Therapeutics' anticancer lerociclib for development in US, Japan, Europe, in deal worth over $300 million (Twitter) - Jul 23, 2020
- lerociclib (G1T38) / G1 Therap, EQRx, fulvestrant / Generic mfg.
[VIRTUAL] Lerociclib (G1T38), a continuously dosed oral CDK4/6 inhibitor, with fulvestrant in HR+/HER2- advanced breast cancer patients: Updated phase II results and dose selection (On-Demand) - Jul 21, 2020 - Abstract #ESMO2020ESMO_652;
P1/2
Funding: G1 Therapeutics, Inc. Clinical trial identification: NCT02983071.
- ||| lerociclib (G1T38) / Walvax
Enrollment closed, Enrollment change, Combination therapy, Metastases: G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jan 27, 2020
P1b/2, N=30, Active, not recruiting, Sponsor: G1 Therapeutics, Inc.
Clinical trial identification: NCT02983071. Recruiting --> Active, not recruiting | N=144 --> 30
- lerociclib (G1T38) / G1 Therapeutics, Faslodex (fulvestrant) / AstraZeneca
Dose escalation and expansion study of lerociclib (G1T38), an oral CDK4/6 inhibitor, dosed with no drug holiday in combination with fulvestrant in patients with HR+/HER2- advanced breast cancer (Hall 1 - Poster Session 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1226;
P1/2
Phase 2b is ongoing to confirm the BID dose (150 mg or 200 mg) for randomized clinical trials. Clinical trial information: NCT02983071.
- Tagrisso (osimertinib) / AstraZeneca, lerociclib (G1T38) / G1 Therapeutics
Lerociclib (G1T38), an oral CDK4/6 inhibitor, dosed continuously in combination with osimertinib for EGFRmut non-small cell lung cancer: Initial phase Ib results (Poster Area (Hall 4)) - Sep 11, 2019 - Abstract #ESMO2019ESMO_1674;
P1b/2
Updated safety, anti-tumor efficacy, and cfDNA data will be presented (NCT#03455829). Clinical trial identification: NCT03455829.
- || lerociclib (G1T38) / Walvax, Pepper Bio
Trial primary completion date, Combination therapy, Metastases: G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - Jun 14, 2019
P1/2, N=102, Recruiting, Sponsor: G1 Therapeutics, Inc.
Clinical trial identification: NCT03455829. Trial primary completion date: Dec 2019 --> Dec 2020
- |||| lerociclib (G1T38) / Walvax
Enrollment open, Combination therapy, Metastases: G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jan 3, 2019
P1b/2, N=144, Recruiting, Sponsor: G1 Therapeutics, Inc.
Trial primary completion date: Dec 2019 --> Dec 2020 Not yet recruiting --> Recruiting
- ||| lerociclib (G1T38) / Walvax
Trial completion: First-in-Human Safety, PK, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Volunteers (clinicaltrials.gov) - May 3, 2017
P1, N=75, Completed, Sponsor: G1 Therapeutics, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- |||| lerociclib (G1T38) / Walvax, Pepper Bio
Enrollment open, Combination therapy, Metastases: G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - Jan 10, 2017
P1/2, N=102, Recruiting, Sponsor: G1 Therapeutics, Inc.
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- || lerociclib (G1T38) / Walvax
Enrollment closed: First-in-Human Safety, PK, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Volunteers (clinicaltrials.gov) - Dec 8, 2016
P1, N=75, Active, not recruiting, Sponsor: G1 Therapeutics, Inc.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- ||||| lerociclib (G1T38) / Walvax, Pepper Bio
New P1/2 trial, Combination therapy, Metastases: G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - Dec 5, 2016
P1/2, N=102, Not yet recruiting, Sponsor: G1 Therapeutics, Inc.
- ||| lerociclib (G1T38) / Walvax
New P1 trial: First-in-Human Safety, PK, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Volunteers (clinicaltrials.gov) - Jul 1, 2016
P1, N=69, Recruiting, Sponsor: G1 Therapeutics, Inc.