Gastric AdenocarcinomaPhase 2SKB264-Fru-GANCT07689292
Sac-TMT Combined With Fruquintinib as Second-Line Treatment in Patients With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Sacituzumab Tirumotecan + Fruquintinib in people with Gastric Adenocarcinoma and Gastroesophageal Junction (GEJ) Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a phase 2 multicenter study that will evaluate the safety and efficacy of sacituzumab tirumotecan (Sac-TMT) plus fruquintinib for the treatment of participants with locally advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma who have failed 1 prior line of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma, Gastro-esophageal Junction Adenocarcinoma
- What is being tested?
- Sacituzumab Tirumotecan + Fruquintinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2026to 31 Dec 2028
- Phase
- Phase 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
- Histologically and/or cytologically confirmed metastatic or locally advanced adenocarcinoma of the gastric or gastroesophageal junction, unresectable;
- Subjects who have failed first-line standard systemic therapy, or experienced disease progression or recurrence within 6 months after completion of adjuvant systemic therapy (HER2-positive subjects must have received prior anti-HER2 therapy);
- Have at least one measurable lesion per RECIST v1.1, subjects with only cutaneous or bone lesions are not eligible for enrollment;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to study drug administration;
- Estimated life expectancy > 12 weeks.
- Adequate organ and bone marrow function (no transfusions, recombinant human thrombopoietin or colony-stimulating factor administered within 2 weeks prior to dosing), defined as follows:
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- Hematology: Absolute neutrophil count (NEUT#) ≥ 1.5×10⁹/L; platelets (PLT) ≥ 80×10⁹/L; hemoglobin ≥ 90 g/L;
- Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); for subjects with baseline liver metastases, ALT and AST ≤ 5 × ULN; albumin ≥ 30 g/L; total bilirubin (TBIL) ≤ 1.5 × ULN;
- Renal function: Creatinine clearance ≥ 50 mL/min (calculated using the standard Cockcroft-Gault formula);
- Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤ 1.5 × ULN.
- All acute toxicities from prior treatments have recovered to Grade 1 or lower (alopecia and vitiligo are excluded). Note: Subjects with any grade of prior endocrine adverse events may be enrolled if they only require maintenance hormone replacement therapy and are stable and asymptomatic at screening.
- Females of childbearing potential and males with partners of childbearing potential must agree to use effective medical contraception from the time of informed consent signature through 6 months after the last dose of study drug;
- The subject voluntarily participates in this study, signs the informed consent form, and is able to comply with protocol-specified study visits and related procedures.
Who cannot join
- Participants unable to receive oral administration due to dysphagia, intractable vomiting, or known drug malabsorption;
- Participants with active gastric/duodenal ulcer, ulcerative colitis, intestinal obstruction, or other gastrointestinal disorders/conditions judged by the Investigator to carry a risk of gastrointestinal hemorrhage or perforation; or with a history of intestinal perforation or fistula within the preceding 6 months; or with unresolved intestinal perforation/fistula following prior surgical repair;
- Participants with known meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or spinal cord compression, or active/untreated central nervous system (CNS) metastases. Participants with previously locally treated brain metastases may be enrolled if clinically stable for at least 4 weeks prior to dosing and not requiring corticosteroids or anticonvulsants for a minimum of 14 days before the first dose;
- Participants diagnosed with another malignant tumor within 3 years prior to dosing, except malignancies cured by local therapy such as basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, carcinoma in situ of the cervix, etc.;
- Participants with clinically significant cardiovascular disease, defined as:
- Severe or uncontrolled cardiac disease or symptomatic cardiac conditions requiring treatment within 6 months prior to the first study dose, including congestive heart failure classified as New York Heart Association (NYHA) Class III or IV, medically refractory unstable angina, severe arrhythmias requiring pharmacotherapy (excluding atrial fibrillation or paroxysmal supraventricular tachycardia), and myocardial infarction;
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- Prior history of myocarditis or cardiomyopathy;
- Baseline corrected QT (QTc) interval > 480 ms;
- Participants with a history of arterial thromboembolism or deep vein thrombosis within the preceding 6 months;
- Participants with documented or historical significant bleeding within 2 months prior to dosing, including melena, hematemesis, hemoptysis, ≥++ fecal occult blood. Subjects with 1+ fecal occult blood and underlying primary gastrointestinal lesions must complete gastroscopy prior to enrollment to rule out active bleeding or ulcers;
- Participants with a history of stroke and/or transient ischemic attack (TIA) within 12 months prior to dosing;
- Participants with severe and/or uncontrolled systemic diseases, such as unregulated metabolic disorders, active inflammatory bowel disease, or gastrointestinal perforation;
- Participants with active hepatitis B [hepatitis B surface antigen (HBsAg)-positive, with HBV-DNA ≥1000 IU/mL or above the lower limit of quantification (LLOQ), whichever is higher] or hepatitis C (hepatitis C antibody-positive with HCV-RNA above the LLOQ). Note: HBsAg-positive subjects must receive anti-HBV antiviral therapy throughout study treatment;
- Participants with known poorly controlled human immunodeficiency virus (HIV) infection; subjects with active syphilis infection;
- Participants with known active pulmonary tuberculosis;
- Participants who have undergone major surgery (as defined by the Investigator) within 30 days prior to the first study dose, or are still in the postoperative recovery phase from prior surgery;
- Participants with a history of severe hypersensitivity reactions to the study drug (including its excipients);
- Participants with a history of non-infectious interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid therapy; current ILD or non-infectious pneumonitis; or suspected ILD/non-infectious pneumonitis that cannot be ruled out via imaging at screening;
- Participants with a history of allogeneic tissue/organ transplantation;
- Participants previously treated with any of the following regimens (including adjuvant or neoadjuvant settings):
- TROP2-targeted therapy;
- Any therapy containing topoisomerase I inhibitors, including antibody-drug conjugates (ADCs);
- Systemic therapy targeting the vascular endothelial growth factor receptor (VEGFR) signaling pathway;
- Participants who received live vaccines within 30 days prior to dosing, or plan to receive live vaccines during the study period;
- Participants requiring strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 2 weeks before the first dose and throughout the study;
- Participants who received chemotherapy, radiotherapy, immunotherapy, or biotherapy within 4 weeks before the first study dose;
- Participants who received small-molecule tyrosine kinase inhibitors (TKIs), anti-tumor hormonal therapy, systemic immune stimulants (including but not limited to interferon, IL-2), or proprietary Chinese medicines with approved anti-tumor indications within 2 weeks before the first study dose;
- Participants with active infection requiring systemic anti-infective therapy within 2 weeks prior to dosing;
- Participants with any disease requiring systemic corticosteroids (>10 mg prednisone equivalent daily) or other immunosuppressants within 14 days before the first study drug administration. Nasal, inhaled, topical, intra-articular corticosteroids, and corticosteroids administered for prophylaxis of infusion reactions are permitted;
- Participants with documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or corneal disorders with a history of impaired/delayed corneal wound healing;
- Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test prior to the first dose;
- Participants with urine protein ≥2+ and 24-hour urinary protein >1 g; or with uncontrolled hypertension despite antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg);
- Any other condition that, in the Investigator's judgment, renders the subject unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With Fruquintinib as Second-Line Therapy for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
This is a phase 2 multicenter study that will evaluate the safety and efficacy of sacituzumab tirumotecan (Sac-TMT) plus fruquintinib for the treatment of participants with locally advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma who have failed 1 prior line of therapy.
- Conditions
- Gastric Adenocarcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma, Gastro-esophageal Junction Adenocarcinoma
- Being tested
- Sacituzumab Tirumotecan + Fruquintinib
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Tirumotecan + FruquintinibDrug
Also called SKB264 + Fruquintinib
Sac TMT: 4mg/kg Q2W, IV Infusion Fruquinitinib: 3mg QD PO, d1-21, Q4W
| Study group | Role | What they receive |
|---|---|---|
| Sac TMT + Fruquintinib | Experimental | Following a 21 day run-in with sacituzumab tirumotecan at 4 mg/kg IV infusion on day 1 of a 2-week cycle plus fruquintinib at 3 mg QD PO on days 1-21 of a 4-week cycle, participants receive sacituzumab tirumotecan at 4 mg/kg IV infusion on day 1 of a 2-week cycle plus fruquintinib at 3 mg QD PO on days 1-21 of a 4-week cycle until discontinuation. Receives: Drug: Sacituzumab Tirumotecan + Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase
DLTs are defined as any drug-related adverse event (AE) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The percentage of participants who experience at least one DLT will be presented.
Measured: Up to ~21 days
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by investigators will be presented.
Measured: Up to 2 years
Secondary outcomes (5)
Progression Free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by investigators will be presented.
Measured: Up to 2 years
Duration of Response (DOR)
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigators will be presented.
Measured: Up to 2 years
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions), Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: less than a 30% decrease and less than a 20% increase in the sum of diameters of target lesions, with no new lesions identified) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1).
Measured: up to 2 years
Overall Survival (OS)
OS is defined as the time from the date of enrollment to the date of death from any cause. OS will be presented.
Measured: up to 3 years
Safety of combinatinal treatment
Percentage of participants who experience a treatment-related AE during the efficacy phase. An AE is any untoward medical occurrence in a clinical study participant which is considered related to the use of the study intervention.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Principal investigator, Ting Deng, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689292
- Sponsor's protocol ID
- SKB264-IIT-031
- Acronym
- SKB264-Fru-GA
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With Fruquintinib as Second-Line Therapy for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07689292
- Acronym / sponsor ID
- SKB264-Fru-GA / SKB264-IIT-031
- Conditions
- Gastric Adenocarcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma, Gastro-esophageal Junction Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2 multicenter study that will evaluate the safety and efficacy of sacituzumab tirumotecan (Sac-TMT) plus fruquintinib for the treatment of participants with locally advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma who have failed 1 prior line of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sac TMT + Fruquintinib | Experimental | Drug: Sacituzumab Tirumotecan + FruquintinibFollowing a 21 day run-in with sacituzumab tirumotecan at 4 mg/kg IV infusion on day 1 of a 2-week cycle plus fruquintinib at 3 mg QD PO on days 1-21 of a 4-week cycle, participants receive sacituzumab tirumotecan at 4 mg/kg IV infusion on day 1 of a 2-week cycle plus fruquintinib at 3 mg QD PO on days 1-21 of a 4-week cycle until discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically and/or cytologically confirmed metastatic or locally advanced adenocarcinoma of the gastric or gastroesophageal junction, unresectable;
- Subjects who have failed first-line standard systemic therapy, or experienced disease progression or recurrence within 6 months after completion of adjuvant systemic therapy (HER2-positive subjects must have received prior anti-HER2 therapy);
- Have at least one measurable lesion per RECIST v1.1, subjects with only cutaneous or bone lesions are not eligible for enrollment;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to study drug administration;
- Estimated life expectancy > 12 weeks.
Key exclusion criteria (33 listed)
- Participants unable to receive oral administration due to dysphagia, intractable vomiting, or known drug malabsorption;
- Participants with active gastric/duodenal ulcer, ulcerative colitis, intestinal obstruction, or other gastrointestinal disorders/conditions judged by the Investigator to carry a risk of gastrointestinal hemorrhage or perforation; or with a history of intestinal perforation or fistula within the preceding 6 months; or with unresolved intestinal perforation/fistula following prior surgical repair;
- Participants with known meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or spinal cord compression, or active/untreated central nervous system (CNS) metastases. Participants with previously locally treated brain metastases may be enrolled if clinically stable for at least 4 weeks prior to dosing and not requiring corticosteroids or anticonvulsants for a minimum of 14 days before the first dose;
- Participants diagnosed with another malignant tumor within 3 years prior to dosing, except malignancies cured by local therapy such as basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, carcinoma in situ of the cervix, etc.;
- Participants with clinically significant cardiovascular disease, defined as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab Tirumotecan + FruquintinibAlso: SKB264 + FruquintinibSac TMT: 4mg/kg Q2W, IV Infusion Fruquinitinib: 3mg QD PO, d1-21, Q4W | Drug | Sac TMT + Fruquintinib |
Primary outcome
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase
Time frame: Up to ~21 days
DLTs are defined as any drug-related adverse event (AE) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The percentage of participants who experience at least one DLT will be presented.
Objective Response Rate (ORR)
Time frame: Up to 2 years
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by investigators will be presented.
5 secondary outcomes
Progression Free Survival (PFS)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: up to 2 years
Overall Survival (OS)
Time frame: up to 3 years
Safety of combinatinal treatment
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Gastric Adenocarcinoma
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Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
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Active, not recruitingPhase 1
A Study of KK2269 in Adult Participants With Solid Tumors
Advanced Solid Tumor, Metastatic Solid Tumor
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Active, not recruitingObservational study
Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery
Clinical Stage 0 Gastric Cancer AJCC v8, Clinical Stage I Gastric Cancer AJCC v8
Active, not recruitingPhase 1/2
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)
Solid Tumors, Gastric Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Tirumotecan + Fruquintinib in people with Gastric Adenocarcinoma and Gastroesophageal Junction (GEJ) Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital.
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 13 inclusion and 33 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: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
Contact Ting Deng, MD (15802243063, xymcdengting@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase (time frame: Up to ~21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.