G1 Clinical Trials

G1 is developing three new oncology therapies that are currently in clinical trials

G1 is advancing three clinical-stage programs, trilaciclib, lerociclib and G1T48, that are designed to enable more effective combination treatment strategies and improve patient outcomes across multiple oncology indications. For more details on G1 clinical trials, please contact clinicalinfo@g1therapeutics.com.

Trilaciclib, a first-in-class myelopreservation therapy designed to improve outcomes of patients who receive chemotherapy by preserving hematopoietic stem and progenitor cell (HSPC) and immune system function, is currently being studied in small cell lung cancer and triple negative breast cancer.

Lerociclib is a potential best-in-class oral CDK4/6 inhibitor being developed for use in combination with other targeted therapies in multiple oncology indications. It is currently being studied in ER+, HER2- breast cancer and EGFRm non-small cell lung cancer.

G1T48 is an oral selective estrogen receptor degrader (SERD) being studied as monotherapy or in combination with other targeted therapies to treat ER+ breast cancer.

G1 Clinical Trials: Lung Cancer

Lung cancer is the second most common cancer in both men and women – according to the American Cancer Society, in the United States alone about 234,000 new case of lung cancer will be diagnosed in 2018. About 154,000 Americans will die from lung cancer in 2018, making it the leading cause of cancer death among both men and women.

G1 is currently studying trilaciclib for the treatment of SCLC and lerociclib for the treatment of EGFRm NSCLC.

Trilaciclib

Three randomized Phase 2 trials of trilaciclib have shown multi-lineage myelopreservation benefits in SCLC patients. In a trial in first-line SCLC, trilaciclib was administered in combination with a chemotherapy regimen of etoposide and carboplatin (NCT02499770); topline data were released in March and additional data were reported at the European Society of Medical Oncology 2018 Congress. In another first-line SCLC trial, trilaciclib was administered in combination with the same chemotherapy regimen and the checkpoint inhibitor Tecentriq® (atezolizumab) (NCT03041311); topline data were reported in November 2018. The company issued a press release on positive topline data from a trial in combination with chemotherapy in previously treated SCLC (NCT02514447) on December 19, 2018.

There are currently no trilaciclib clinical trials enrolling new participants.

Click here for trilaciclib data publications and presentations.

Lerociclib

G1 is currently enrolling participants in a clinical trial evaluating lerociclib in combination with Tagrisso® (osimertinib) in EGFRm NSCLC. For more information, please see clinicaltrials.gov identifier: NCT03455829.

Click here for lerociclib data publications and presentations.

G1 Clinical Trials: Breast Cancer

Breast cancer is the most common cancer in American women, except for skin cancers. Approximately one in eight women (12%) will develop breast cancer in their lifetime.

All three of G1’s clinical-stage therapies are being studied as treatments for breast cancer.

Trilaciclib

Preliminary results from a trial in combination with chemotherapy in metastatic triple-negative breast cancer (NCT02978716) showing enhanced progression-free survival and multi-lineage myelopreservation benefits were presented at the San Antonio Breast Cancer Symposium on December 5, 2018. This trial is no longer enrolling participants.

Click here for trilaciclib data publications and presentations.

Lerociclib

G1 is currently enrolling participants in a clinical trial evaluating lerociclib in combination with Faslodex® (fulvestrant) in ER+, HER2- breast cancer. Preliminary data from this trial presented at ASCO 2018 showed promising safety, tolerability and efficacy. For more information, please see clinicaltrials.gov identifier: NCT02983071.

Click here for lerociclib data publications and presentations.

G1T48

G1 is currently enrolling participants in a clinical trial evaluating G1T48 in ER+, HER2- breast cancer. For more information, please see clinicaltrials.gov identifier: NCT03455270.

Click here for G1T48 data publications and presentations.