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

NCT05113966 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: G1T28-213
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 22

Brief Summary

This was a Phase 2, multicenter, open-label, single-arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in participants 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.

Conditions

Triple Negative Breast Cancer

Keywords

TNBC; Trodelvy; Myelosuppression

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression free survival was defined as the time (months) from the date of the first dose of the study drug to the date of documented radiographic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

  Up to approximately 23 months

Secondary Outcomes (15)

• Objective Response Rate (ORR)

  Up to approximately 24 months

• Clinical Benefit Rate (CBR)

  Up to approximately 24 months

• Duration of Objective Response (DOR)

  Up to approximately 24 months

• Overall Survival (OS)

  Up to approximately 24 months

• Number of Participants With Occurrence of Severe Neutropenia (SN)

  Up to approximately 24 months

Study Arms (1)

Trilaciclib + Sacituzumab Govitecan-hziy

EXPERIMENTAL

Participants received 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.

Drug: Trilaciclib; Drug: Sacituzumab Govitecan-hziy

Interventions

Trilaciclib DRUG

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

Also known as: G1T28, CDK 4/6 inhibitor

Trilaciclib + Sacituzumab Govitecan-hziy

Sacituzumab Govitecan-hziy DRUG

10 milligram per kilogram (mg/kg) reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline

Also known as: Trodelvy, IMMU-132

Trilaciclib + Sacituzumab Govitecan-hziy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ( ≥18 years of age), female or male participant with measurable (per RECIST v1.1), unresectable locally advanced or metastatic TNBC
• Documentation of histologically or cytologically confirmed ER-negative, PR-negative, and HER2-negative tumor per the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (ASCO/CAP) criteria.
• Measurable disease as defined by RECIST v1.1.
• Considered to be eligible to receive sacituzumab govitecan-hziy treatment, in the Investigator's judgment.
• Participants must have received 2 or more prior lines of systemic therapy, at least one of them in the metastatic setting.
• Radiation therapy for metastatic disease is permitted as long as the participant has at least 1 measurable lesion that has not been irradiated. Participants should be sufficiently recovered from the effects of radiation as determined by the Investigator but must have completed radiotherapy at least 2 weeks prior to enrollment.
• ECOG performance status of 0 or 1.
• Adequate organ function as demonstrated by the following laboratory values:
• Hemoglobin ≥9.0 g/dL
• Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L;
• Platelet count ≥100 × 10\^9/L;
• Estimated glomerular filtration rate ≥30 mL/minute/1.73 m\^2;
• Total bilirubin ≤1.5 × upper limit of normal (ULN);
• ALT and AST ≤3 × ULN in the absence of liver metastasis or ≤5 × ULN in the presence of liver metastasis.
• Resolution of nonhematologic toxicities from prior systemic therapy, radiation therapy, or surgical procedures to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade 1 (except alopecia or peripheral neuropathy that may be Grade 2 or less).

You may not qualify if:

• Prior treatment with trilaciclib, sacituzumab govitecan-hziy, irinotecan, Trop-2 antibody drug conjugate, or any therapy with a topoisomerase-1 payload.
• Participants with known brain metastasis at enrollment.
• Participants with known Gilbert's disease or known homozygous for the UGT1A1\*28 allele.
• Participants with bone-only disease.
• Malignancies other than TNBC within 3 years prior to enrollment. Participants with malignancies of a negligible risk of metastasis or death (e.g., risk of metastasis or death \<5% at 5 years as determined by the Investigator) are eligible provided they meet all of the following criteria:
• Malignancy treated with expected curative intent (e.g., adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent);
• No evidence of recurrence or metastasis by follow-up imaging and any disease-specific tumor markers.
• History of clinically significant gastrointestinal bleeding, intestinal obstruction, or gastrointestinal perforation within 6 months of enrollment.
• Receipt of any investigational medication within 4 weeks, or at least 5 half-lives, whichever is greater, prior to the first dose of study treatment.
• Receipt of any cytotoxic chemotherapy within 2 weeks or antibody treatment for cancer within 3 weeks prior to the first dose of study treatment.
• Receipt of any high dose systemic corticosteroids within 2 weeks prior to the first dose of study treatment.
• Low dose corticosteroids (≤20 mg prednisone or equivalent daily) are permitted if the dose is stable for 4 weeks, or if medically indicated as part of their pre-medications for infusions.
• Topical steroids and corticosteroid inhalers are allowed.
• Current use of immunosuppressive medication, except for the following:
• Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);

Sponsors & Collaborators

• G1 Therapeutics, Inc.: lead

Study Sites (22)

Ironwood Physicians

Chandler, Arizona, 85224, United States

Location

Comprehensive Blood & Cancer Center

Bakersfield, California, 93309, United States

Location

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, 90017, United States

Location

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

Location

UCLA Hematology/Oncology Parkside

Santa Monica, California, 90404, United States

Location

PIH Health

Whittier, California, 90602, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80220, United States

Location

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

Duly Health and Care

Joliet, Illinois, 60435, United States

Location

New England Cancer Specialists

Scarborough, Maine, 04704, United States

Location

Minnesota Oncology Hematology, P.A.

Woodbury, Minnesota, 55125, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89128, United States

Location

Northwest Cancer Specialists, PC

Tigard, Oregon, 97223, United States

Location

Texas Oncology - Austin Central

Austin, Texas, 78731, United States

Location

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology - Longview Cancer Center

Longview, Texas, 75601, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc

Roanoke, Virginia, 24014, United States

Location

Multicare Health System

Auburn, Washington, 98001, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

trilaciclib; sacituzumab govitecan

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Trial Info.
• Organization: G1 Therapeutics, Inc.

clinicalinfo@g1therapeutics.com

919-213-9835

Study Officials

• Clinical Conduct

  G1 Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 9, 2021
• Study Start: December 8, 2021
• Primary Completion: November 10, 2023
• Study Completion: June 13, 2024
• Last Updated: January 29, 2025
• Results First Posted: January 29, 2025

Record last verified: 2024-11

Locations

US (22)