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Advanced Solid TumorPhase 1/2ASCENT-J02NCT05101096

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

A Phase 1/2 study testing Sacituzumab Govitecan-hziy in people with Advanced Solid Tumor and Metastatic Triple-Negative Breast Cancer, run by Gilead Sciences at 36 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacituzumab Govitecan-hziy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
36 sitesJapan
Study dates
20 Oct 2021to May 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 locally advanced unresectable or 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

Japan36 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • Akita University Hospital

    Akita, 010-8543

  • Tohoku University Hospital

    Aoba-ku, 980-8574

  • Hirosaki University Hospital

    Aomori, 036-8563

  • Kanagawa Cancer Center

    Asahi-ku, 241-8515

  • Juntendo University Hospital

    Bunkyō City, 113-8431

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • Chiba Cancer

    Chūōku, 260-8717

  • Nagoya University Hospital

    Chūōku, 540-0006

  • Osaka International Cancer Institute

    Chūōku, 541-8567

  • Shikoku Cancer Center

    Ehime, 791-0245

  • National Hospital Organization Shikoku Cancer Center

    Ehime, 791-0280

  • Hyogo Cancer Center

    Hyōgo, 673-8558

  • Kagawa University Hospital

    Kagawa, 761-0793

  • Tokai University School of Medicine

    Kanagawa, 259-1193

  • The Cancer Institute Hospital of JFCR

    Kōtō City, 135-8550

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Hiroshima University Hospital

    Minamiku, 734-8551

  • Nara Medical University Hospital

    Nara, 634-8522

  • Hyogo College of Medicine College Hospital

    Nishinomiya-shi, 663-8501

  • Okayama University Hospital

    Okayama, 700-8558

  • Osaka International Cancer Institute

    Osaka, 5418567

  • Osaka Metropolitan University Hospital

    Osaka, 545-0051

  • Osaka University Hospital

    Osaka, 565-0871

  • Kindai University Hospital

    Osaka, 577-8502

  • Kindai University Hospital

    Osakasayama-shi, 589-8511

  • Saitama Medical University

    Saitama, 350-1298

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, 003-0804

  • National Center for Global Health and Medicine

    Shinjuku-ku, 162-8655

  • National Cancer Center hospital

    Tokyo, 104-0045

  • Tokyo Medical And Dental University, Medical Hospital

    Tokyo, 113-8519

  • Showa University Hospital

    Tokyo, 142-8555

  • Keio University Hospital

    Tokyo, 1608582

  • Yamaguchi University Hospital

    Yamaguchi, 755-0046

Other trials in Japan

About this study

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

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).

Being tested
Sacituzumab Govitecan-hziy
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab Govitecan-hziyDrug

    Also called IMMU-132, Trodelvy™, GS-0132

    Administered intravenously (IV)

Study groups in NCT05101096
Study groupRoleWhat they receive
Sacituzumab Govitecan-hziy 6 mg, Advanced Solid TumorsExperimental(Phase 1 Cohort A: dose escalation) Japanese participants with advanced solid tumors will receive sacituzumab govitecan-hziy (SG) 6 mg/kg by intravenous (IV) injection on Day 1 and Day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Receives: Drug: Sacituzumab Govitecan-hziy
Sacituzumab Govitecan-hziy 8 mg, Advanced Solid TumorsExperimental(Phase 1 Cohort A: dose escalation) Japanese participants with advanced solid tumors will receive SG 8 mg/kg by IV injection on Day 1 and Day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Receives: Drug: Sacituzumab Govitecan-hziy
Sacituzumab Govitecan-hziy 10 mg, Advanced Solid TumorsExperimental(Phase 1 Cohort A: dose escalation) Japanese participants with advanced solid tumors will receive SG 10 mg/kg by IV injection on Day 1 and Day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Receives: Drug: Sacituzumab Govitecan-hziy
Sacituzumab Govitecan-hziy 6 mg, UGT1A1 PolymorphismExperimental(Phase 1 Cohort B: dose escalation) Japanese participants with UGT1A1 polymorphism will receive SG 6 mg/kg by IV injection on Day 1 and Day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Receives: Drug: Sacituzumab Govitecan-hziy
Sacituzumab Govitecan-hziy 10 mg, UGT1A1 PolymorphismExperimental(Phase 1 Cohort B: dose escalation) Japanese participants with UGT1A1 polymorphism will receive SG 10 mg/kg by IV injection on Day 1 and Day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Receives: Drug: Sacituzumab Govitecan-hziy
Sacituzumab Govitecan-hziy, Metastatic Triple-negative Breast Cancer (mTNBC)Experimental(Phase 2: dose expansion) Japanese participants with mTNBC will receive SG at the recommended Phase 2 dose (RP2D) on Day 1 and Day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Receives: Drug: Sacituzumab Govitecan-hziy
Sacituzumab Govitecan-hziy, HR+/HER2- Metastatic Breast Cancer (HR+/HER2- mBC)Experimental(Phase 2) Japanese participants with HR+/HER2- mBC will receive SG at the recommended Phase 2 dose (RP2D) on Day 1 and Day 8 of a 21 day cycle until disease progression or unacceptable toxicity.
Receives: Drug: Sacituzumab Govitecan-hziy
Sacituzumab Govitecan-hziy, Metastatic Urothelial Carcinoma (mUC)Experimental(Phase 2) Japanese participants with mUC will receive SG at the recommended Phase 2 dose (RP2D) on Day 1 and Day 8 of a 21 day cycle until disease progression or unacceptable toxicity.
Receives: Drug: Sacituzumab Govitecan-hziy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: First dose date to last dose date (Up to 15 weeks) plus 30 days

  2. 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

    Measured: First dose date to last dose date (Up to 15 weeks) plus 30 days

  3. Phase 1: Percentage of Participants Experiencing Dose-limiting toxicity (DLTs) per Dose level

    Measured: First dose date up to 21 days

  4. Phase 2:(Metastatic Triple-negative Breast Cancer (mTNBC);Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2-negative Metastatic Breast Cancer (HR+/HER2- mBC) Cohorts):Objective Response Rate (ORR) as Assessed by 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) as assessed by Independent Review Committee (IRC).

    Measured: Up to 17 months

  5. Phase 2 (Metastatic Urothelial Cancer (mUC) Cohort): ORR as Assessed by Investigator

    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)

    Measured: Up to 17 months

Secondary outcomes (14)

  1. 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

    Measured: Up to 33 months

  2. Phase 1: PK Parameter: Tmax of SG and Free SN-38

    Tmax is defined as time (observed time point) of Cmax

    Measured: Up to 33 months

  3. Phase 1: PK Parameter: 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.

    Measured: Up to 33 months

  4. Phase 1 : Percentage of Participants Who Develop Anti-Drug Antibodies (ADAs) Against SG

    Measured: Up to 33 months

  5. Phase 2 (All Cohorts): Percentage of Participants Experiencing TEAEs Defined by NCI CTCAE Version 4.03

    Measured: First dose date to last dose date (Up to 33 months) plus 30 days

  6. Phase 2 (All Cohorts): Percentage of Participants Experiencing Laboratory Abnormalities Defined by NCI CTCAE Version 4.03

    Measured: First dose date to last dose date (Up to 33 months) plus 30 days

  7. Phase 2(All Cohorts): Progression-free survival (PFS) as 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.

    Measured: Up to 33 months

  8. Phase 2 (All Cohorts): ORR as Assessed by Investigator

    ORR is defined as the proportion of participants who achieve a CR or PR as assessed by RECIST v1.1.

    Measured: Up to 17 months

  9. Phase 2 (All Cohorts): Overall Survival (OS)

    OS is defined as the time from date of first dose of SG to death from any cause, whichever comes first.

    Measured: Up to 33 months

  10. Phase 2 (All Cohorts): Duration of Response (DOR) as 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.

    Measured: Up to 33 months

  11. Phase 2 (All Cohorts): Time to response (TTR) as Assessed by Investigator

    TTR is defined as the time from first dose of SG to the first documentation of CR or PR.

    Measured: Up to 17 months

  12. Phase 2 (mTNBC and HR+/HER2- mBC Cohorts): Progression-free survival (PFS) as 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.

    Measured: Up to 33 months

  13. Phase 2 (mTNBC and HR+/HER2- mBC Cohorts): Duration of Response (DOR) as 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.

    Measured: Up to 33 months

  14. Phase 2 (mTNBC and HR+/HER2- mBC Cohorts): Time to response (TTR) as Assessed by IRC

    TTR is defined as the time from first dose of SG to the first documentation of CR or PR.

    Measured: Up to 17 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2021
  2. Study start20 Oct 2021
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05101096
Sponsor's protocol ID
GS-US-569-6172
Other IDs
jRCT2031210346
Acronym
ASCENT-J02
Status last verified
Jul 2026
First submitted
19 Oct 2021
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Naito Y, Nakamura S, Kawaguchi-Sakita N, Ishida T, Nakayama T, Yamamoto Y, Masuda N, Matsumoto K, Kogawa T, Sudo K, Shimomura A, Lai C, Zhang D, Iwahori Y, Gary D, Huynh D, Iwata H. Preliminary results from ASCENT-J02: a phase 1/2 study of sacituzumab govitecan in Japanese patients with advanced solid tumors. Int J Clin Oncol. 2024 Nov;29(11):1684-1695. doi: 10.1007/s10147-024-02589-x. Epub 2024 Sep 20.

    PubMed 39302614

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sacituzumab Govitecan-hziy in people with Advanced Solid Tumor and Metastatic Triple-Negative Breast Cancer, run by Gilead Sciences at 36 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: First dose date to last dose date (Up to 15 weeks) plus 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05101096, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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ASCENT-J02 Clinical Trial NCT05101096 | AzTrials