G1 Clinical Trials

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

The Company is advancing its lead clinical compound trilaciclib, a first-in-class therapy designed to improve outcomes for patients who are treated with chemotherapy, in clinical trials assessing myeloprotection and anti-tumor efficacy endpoints in a variety of tumors types.  To learn more about our clinical trials, please visit www.clinicaltrials.gov or contact us at clinicalinfo@g1therapeutics.com.

Patients and families should speak to their physician about risks and benefits of a clinical trial and to ask whether a study is right for them.

Trilaciclib

Trilaciclib is a first-in-class therapy designed to improve outcomes for people with cancer who are treated with chemotherapy. Trilaciclib is currently being studied in colorectal cancer (“CRC”), metastatic triple negative breast cancer (“mTNBC”), neoadjuvant breast cancer, non-small cell lung cancer (“NSCLC”) and bladder cancer

Tumor type

Trial name

Description

Link

Status

1L metastatic colorectal cancer (CRC)

PRESERVE 1

Phase 3 double-blind placebo-controlled trial of trilaciclib in patients receiving FOLFOXIRI/bevacizumab for metastatic colorectal cancer.

https://clinicaltrials.gov/ct2/show/NCT04607668?term=trilaciclib&draw=2&rank=3

Recruiting

1L metastatic triple negative breast cancer

PRESERVE 2

Phase 3 double-blind placebo-controlled trial of trilaciclib in patients receiving 1L or 2L gemcitabine and carboplatin chemotherapy for locally advanced unresectable or metastatic triple-negative breast cancer.

https://clinicaltrials.gov/ct2/show/NCT04799249?term=trilaciclib&draw=2&rank=4

Recruiting

1L bladder cancer (mUC)

PRESERVE 3

Phase 2 randomized open-label trial of trilaciclib in patients receiving 1L platinum-based chemotherapy and the immune checkpoint inhibitor avelumab maintenance therapy for untreated, locally advanced or metastatic urothelial carcinoma (mUC).

https://clinicaltrials.gov/ct2/show/NCT04887831?term=trilaciclib&draw=2&rank=8

Recruiting

 Metastatic 2L/3L triple negative breast cancer (TNBC) 

ADC combination study Phase 2, single arm, open-label study of trilaciclib administered prior to the antibody-drug conjugate (ADC), Trodelvy® (sacituzumab govitecan-hziy) in patients with unresectable locally advanced or metastatic TNBC. https://clinicaltrials.gov/ct2/show/NCT05113966?term=trilaciclib&draw=2&rank=5

Recruiting

Neoadjuvant triple negative breast cancer (TNBC)  Mechanism of action study Phase 2, single arm, open-label study of trilaciclib in patients with early-stage TNBC designed to further investigate the role of trilaciclib in modulating the anti-tumor immune response https://clinicaltrials.gov/ct2/show/NCT05112536?term=trilaciclib&draw=2&rank=6 Recruiting