Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Pharmaceutical Solutions

Sacituzumab govitecan

Immunoconjugates

Immunologic Factors

During the Treatment Phase patients will receive trilaciclib + sacituzumab govitecan-hziy on days 1 \& 8 of a 21 day cycle. Trilaciclib is administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion to be completed within 4 hours prior to the start of sacituzumab govitecan-hziy.

Single-use, sterile powder to be reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or dextrose 5% in water (D5W)

Trilaciclib

10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline

Sacituzumab Govitecan-hziy

Clinical Conduct

This is a Phase 2, multicenter, open-label, single arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who received at least 2 prior treatments, at least 1 in the metastatic setting.

The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of the first dose of study treatment and completes at the Safety Follow-up Visit. Trilaciclib and sacituzumab govitecan-hziy will be administered intravenously (IV) in 21-day cycles. Study drug administration will continue until progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or clinical progression as determined by the Investigator, unacceptable toxicity, withdrawal of consent, Investigator decision, or the end of the study, whichever occurs first. The first Survival Follow-up assessment should occur approximately 3 months after the Safety Follow-Up Visit and will continue every 3 months until the end of the study (or death).

Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer

Trilaciclib Administered Prior to Sacituzumab Govitecan-hziy in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments, at Least One in the Metastatic Setting

Progression free survival defined as time from the date of first dose of study drug to radiographic disease progression using RECIST v1.1 or death due to any cause, whichever occurs first; for patients without disease progression or death, PFS will be calculated per censoring rules.

Objective response rate defined as the percentage of patients with best overall response of confirmed complete response or confirmed partial response per RECIST v1.1

Clinical benefit rate defined as the percentage of patients with a best overall response of confirmed complete response, confirmed partial response, or stable disease lasting 24 weeks or longer since the first date of study drug administration per RECIST v1.1

Overall survival defined as time from the date of first dose of study drug to death due to any cause for those who died; or time to last contact known as alive for those who survived in the study (censored cases)

Occurrence of severe neutropenia (in Cycles 1/2 and the overall on study), occurrence of febrile neutropenia AEs , and occurrence of G-CSF administration

Occurrence of Grade 3/4 decrease of hemoglobin, occurrence and number of RBC transfusions on/after Week 5, and occurrence of ESA administration

Occurrence of Grade 3/4 decrease of platelets and occurrence and number of platelet transfusions

Occurrence and severity of AEs by NCI CTCAE v5.0

G1 Therapeutics, Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Lung Neoplasms

Urinary Bladder Neoplasms

Antineoplastic Agents

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

IDE397

IDEAYA Clinical Trials

Maroof Khan Zafar

New Patient Services

Teresa Lund

Estefania Bobe Cortes

Heather Flynn

Carol Goldener

Kailene Sullivan

Brandon Smith

Benjamin Herzberg, MD

Alexandra Mavracick

Christina Seunath

Benedito Carneiro

askSARAH

Jordi Rodon, MD

Carmen Gonzalez

Jia Liu

Ganessan Kichenadasse

Antoine Italiano

Eulalie Magne

Laurent Greillier

Thibault De la Motte Rouge

Frank Knauer

Ki Hyeong Lee

Ji-Youn Han

Joo-Hang Kim

Hye Ryun Kim

Changmin Choi

Montserrat Pequera Juvany

Elisa Lorente

Marta Benitez

Jorge Mercado

Laura Bailach

Ya-Zong Hsu

Chia-Chi Lin

Jasgit Sachdev, MD

This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in combination with other anticancer agents including taxanes (docetaxel, paclitaxel), or sacituzumab govitecan (SG), in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).

Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants With Advanced Solid Tumors

Incidence of DLTs of IDE397 will be determined

Incidence of DLTs of IDE397 in a combination setting will be determined

MTD and RP2D of IDE397 will be determined

MTD and RP2D of IDE397 in a combination setting will be determined

Objective Response Rate (ORR) and Duration of Response (DoR)

Pharmacokinetics of IDE397 and metabolite following single and multiple oral administration as a single agent and in combination with docetaxel or paclitaxel or sacituzumab govitecan, will be determined

Pharmacokinetics of docetaxel or paclitaxel or sacituzumab govitecan.

Changes in the levels of MAT2A pathway and PRMT5 pathway will be determined

Objective response rate and duration of response will be assessed by Investigator using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer	NCT05113966	Triple Negative...	Trilaciclib Sacituzumab Gov...	18 Years -	G1 Therapeutics, Inc.
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion	NCT04794699	Solid Tumor	IDE397 Docetaxel Paclitaxel Sacituzumab gov...	18 Years -	IDEAYA Biosciences

Spots Global Cancer Trial Database for trodelvy

Every month we try and update this database with for trodelvy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for trodelvy

Every month we try and update this database with for trodelvy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for trodelvy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.