Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

— ASCENT-J02  

Official title:

A Phase 1/2 Open-Label Study of Sacituzumab Govitecan in Japanese Patients With Advanced Solid Tumors (ASCENT-J02)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05101096
• Other study ID #: GS-US-569-6172
• Secondary ID: jRCT2031210346
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 20, 2021
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: Gilead Sciences
• Contact: Gilead Clinical Study Information Center
• Phone: 1-833-445-3230 (GILEAD-0)
• Email: GileadClinicalTrials[@]gilead.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are as follows:

Phase 1 (sequential dose-escalation): to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent and to determine the recommended Phase 2 dose (RP2D) of SG in Japanese participants with advance solid tumors.

Phase 2: Evaluate the safety and efficacy of SG in Japanese participants with metastatic triple-negative breast cancer (mTNBC), hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC), and metastatic urothelial cancer (mUC).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 143
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status = 1

• Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria

• Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation

• Adequate hepatic function (bilirubin = 1.5 upper limit of normal (ULN)), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 ULN

• Creatinine clearance = 30 mL/min

• Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.

• Phase 1 only: Histologically or cytologically confirmed advanced solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.

• Phase 2 metastatic triple-negative breast cancer (mTNBC) Cohort: Histologically or cytologically confirmed TNBC per American Society of Clinical Oncologists/College of American Pathologists (ASCO/CAP) criteria, based on the most recent analyzed biopsy or other pathology specimen. Refractory to or relapsed after at least 2 prior standard-of-care chemotherapy regimens for unresectable, locally advanced or metastatic breast cancer.

• Phase 2 hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (HR+/HER2- mBC) Cohort: Documented evidence of HR+/HER2- mBC confirmed by a local laboratory and defined per ASCO/CAP criteria.

• Refractory to or relapsed after 2 prior systemic chemotherapy regimens for metastatic disease.

• Phase 2 metastatic urothelial cancer (mUC) Cohort: Histologically documented UC that is metastatic or locally advanced unresectable.

• Progressed or recurred following receipt of platinum-containing regimen and anti-PD-1/PD-L1 therapy for metastatic or locally advanced unresectable disease

Key Exclusion Criteria:

• Positive serum pregnancy test, or females who may possibly be pregnant

• Known Gilbert's disease

• Have previously received antibody drug conjugate containing topoisomerase I inhibitors

• Presence of bulky disease (defined as any single mass > 7 cm in greatest dimension).

• Known to be HIV positive, or hepatitis B virus (HBV) surface antigen positive or hepatitis C virus (HCV) antibody positive at screening

• Known history of significant cardiac disease

• Known history of clinically significant active chronic obstructive pulmonary disease, or other moderate-to-severe chronic respiratory illness

• History of interstitial lung disease

• History of clinically significant gastrointestinal (GI) bleeding, have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation

• Individuals with a history of anaphylactic reaction to irinotecan.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Breast Neoplasms
• Metastatic Triple-Negative Breast Cancer
• Metastatic Urothelial Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Sacituzumab Govitecan-hziy
Administered intravenously (IV)

Locations

Country	Name	City	State
Japan	Aichi Cancer Center Hospital	Aichi
Japan	Akita University Hospital	Akita
Japan	Tohoku University Hospital	Aoba-ku
Japan	Hirosaki University Hospital	Aomori
Japan	Kanagawa Cancer Center	Asahi-ku
Japan	Juntendo University Hospital	Bunkyo-ku
Japan	Chiba Cancer Center	Chiba
Japan	National Cancer Center Hospital East	Chiba
Japan	Chiba Cancer	Chuo-ku
Japan	Nagoya University Hospital	Chuo-ku
Japan	Osaka International Cancer Institute	Chuo-ku
Japan	National Hospital Organization Shikoku Cancer Center	Ehime
Japan	Shikoku Cancer Center	Ehime
Japan	Hyogo Cancer Center	Hyogo
Japan	Kagawa University Hospital	Kagawa
Japan	Tokai University School of Medicine	Kanagawa
Japan	The Cancer Institute Hospital of JFCR	Koto
Japan	Kumamoto University Hospital	Kumamoto- shi
Japan	Kyoto University Hospital	Kyoto
Japan	Hiroshima University Hospital	Minami-ku
Japan	Nara Medical University Hospital	Nara
Japan	Hyogo College of Medicine College Hospital	Nishinomiya-shi
Japan	Okayama University Hospital	Okayama
Japan	Okayama University Hospital	Okayama
Japan	Kindai University Hospital	Osaka
Japan	Osaka International Cancer Institute	Osaka
Japan	Osaka Metropolitan University Hospital	Osaka
Japan	Osaka University Hospital	Osaka
Japan	Kindai University Hospital	Osakasayama-shi
Japan	Saitama Medical University	Saitama
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo
Japan	National Center for Global Health and Medicine	Shinjuku-ku
Japan	Keio University Hospital	Tokyo
Japan	National Cancer Center hospital	Tokyo
Japan	Showa University Hospital	Tokyo
Japan	Tokyo Medical And Dental University, Medical Hospital	Tokyo
Japan	Yamaguchi University Hospital	Yamaguchi

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03		First dose date to last dose date (Up to 15 weeks) plus 30 days
Primary	Phase 1: Percentage of Participants Experiencing laboratory abnormalities Defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03		First dose date to last dose date (Up to 15 weeks) plus 30 days
Primary	Phase 1: Percentage of Participants Experiencing Dose-limiting toxicity (DLTs) per Dose level		First dose date up to 21 days
Primary	Phase 2: Objective Response Rate (ORR) Assessed by Independent Review Committee (IRC)	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) confirmed at least 4 weeks later as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	Up to 17 months
Secondary	Phase 1:Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy (SG) and Free SN-38	Cmax is defined as the maximum observed concentration of drug	Up to 33 months
Secondary	Phase 1:PK parameters Tmax of SG and Free SN-38	Tmax is defined as time (observed time point) of Cmax	Up to 33 months
Secondary	Phase 1:PK parameters AUC0-168h of SG and Free SN-38	AUC0-168h is defined as partial area under the concentration of drug over time between 0 to time 168-hour.	Up to 33 months
Secondary	Phase 1: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs) Against SG		Up to 33 months
Secondary	Phase 2: Percentage of Participants Experiencing TEAEs Defined by NCI CTCAE Version 4.03		First dose date to last dose date (Up to 33 months) plus 30 days
Secondary	Phase 2: Percentage of Participants Experiencing Laboratory Abnormalities Defined by NCI CTCAE Version 4.03		First dose date to last dose date (Up to 33 months) plus 30 days
Secondary	Phase 2: Progression-free survival (PFS) Assessed by Investigator	PFS is defined as the interval from the first dose of SG to the earlier of the first documentation of objective progressive disease (PD) or death from any cause, whichever comes first.	Up to 33 months
Secondary	Phase 2: ORR Assessed by Investigator	ORR is defined as the proportion of participants who achieve a CR or PR as assessed by RECIST v1.1.	Up to 17 months
Secondary	Phase 2: Overall Survival (OS)	OS is defined as the time from date of first dose of SG to death from any cause, whichever comes first.	Up to 33 months
Secondary	Phase 2: Duration of Response (DOR) Assessed by Investigator	DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause.	Up to 33 months
Secondary	Phase 2: Time to response (TTR) Assessed by Investigator	TTR is defined as the time from first dose of SG to the first documentation of CR or PR.	Up to 17 months
Secondary	Phase 2: Progression-free survival (PFS) Assessed by IRC	PFS is defined as the interval from the first dose of SG to the earlier of the first documentation of objective progressive disease (PD) or death from any cause, whichever comes first.	Up to 33 months
Secondary	Phase 2: Duration of Response (DOR) Assessed by IRC	DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause.	Up to 33 months
Secondary	Phase 2: Time to response (TTR) Assessed by IRC	TTR is defined as the time from first dose of SG to the first documentation of CR or PR.	Up to 17 months

External Links

•   Gilead Clinical Trials Website