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ESCCPhase 2NCT07701681

Sacituzumab Tirumotecan (Sac-TMT/SKB264) Plus Tagitanlimab (KL-A167) in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma and Gastric/Gastroesophageal Junction Adenocarcinoma

A Phase 2 study testing Sacituzumab Tirumotecan + Tagitanlimab in people with ESCC and Gastric Adenocarcinoma, run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a single-arm, multi-center phase II study to evaluate the efficacy and safety of sacituzumab tirumotecan (Sac-TMT/SKB264) combined with tagitanlimab (KL-A167) as 2nd line therapy for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) or gastric/gastroesophageal junction adenocarcinoma (G/GEJA). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacituzumab Tirumotecan + Tagitanlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteChina
Study dates
31 Aug 2026to 1 Sep 2029
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

  • Aged ≥18 years at the time of signing the informed consent form;
  • Histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) or gastric/gastroesophageal junction (GEJ) adenocarcinoma;
  • Esophageal squamous cell carcinoma (ESCC) and gastric/gastroesophageal junction (GEJ) adenocarcinoma with disease progression following first-line anti-PD-1 combined chemotherapy, and the progression-free survival (PFS) of first-line treatment ≥3 months;
  • Radical concurrent chemoradiotherapy, neoadjuvant or adjuvant therapy: disease progression occurring during treatment or within 6 months after treatment discontinuation shall be deemed failure of first-line treatment.
  • (Note: This also includes patients with advanced or recurrent non-target lesions who experience re-progression after radiotherapy alone. The criteria also apply to patients receiving palliative treatment for local (non-target) lesions for more than 2 weeks.)
  • Patients with HER2-positive gastric/gastroesophageal junction adenocarcinoma must have received prior anti-HER2 therapy;
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  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to the first administration of study treatment;
  • Expected survival ≥3 months;
  • At least one measurable lesion per RECIST v1.1; lesions previously irradiated shall not be selected as target lesions; subjects with only skin lesions or bone lesions are not eligible for enrollment;
  • Participants must have recovered from all toxicities related to prior treatments (i.e., improved to Grade 0 or Grade 1, or met the levels specified in the eligibility criteria), except for toxicities not considered a safety risk (e.g., alopecia, vitiligo, and other asymptomatic laboratory abnormalities);
  • Adequate organ function defined as follows:
  • Hematology (no blood transfusion or hematopoietic stimulating agents for correction within 14 days): hemoglobin (Hb) ≥9 g/dL; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count (PLT) ≥100×10⁹/L; neutrophil count (NEUT#) ≥1.5×10⁹/L;
  • Serum total bilirubin ≤1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤2.5 × ULN.
  • For subjects with liver metastases: ALT and AST ≤5 × ULN, serum bilirubin ≤2 × ULN.
  • For subjects with liver and/or bone metastases: ALP ≤5 × ULN; serum albumin ≥30 g/L;
  • Renal function: creatinine clearance (Ccr) ≥50 mL/min;
  • Coagulation function: international normalized ratio (INR), activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤1.5 × ULN.
  • Female participants of childbearing potential and male subjects with partners of childbearing potential must agree to use effective medical contraceptive measures from the date of signing the informed consent form until 6 months after the last study drug administration (see Appendix 2 for details);
  • Participants must voluntarily participate in this study, sign the informed consent form, and demonstrate good treatment compliance and willingness to complete follow-up visits.

Who cannot join

  • Participants diagnosed with other malignant tumors within 3 years prior to study drug administration, except for tumors cured by local therapy (e.g., basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, cervical carcinoma in situ, etc.);
  • Participants with known meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or spinal cord compression, or active central nervous system (CNS) metastases without prior local treatment. Participants with previously locally treated brain metastases may be enrolled if they remain clinically stable for at least 4 weeks prior to the first dose and do not require corticosteroids or anticonvulsants for a minimum of 14 days;
  • Participants with clinically significant cardiovascular diseases, including:
  • Severe or uncontrolled cardiac disorders or clinical symptoms requiring treatment within 6 months before the first study dose, including New York Heart Association (NYHA) Class III or IV congestive heart failure, drug-refractory unstable angina, severe arrhythmias requiring pharmacotherapy (excluding atrial fibrillation or paroxysmal supraventricular tachycardia), and myocardial infarction;
  • Prior history of myocarditis or cardiomyopathy;
  • QTc interval >480 ms at baseline measurement;
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  • Participants with severe and/or uncontrolled concomitant diseases, such as decompensated cirrhosis, nephrotic syndrome, poorly controlled hypertension, symptomatic pleural/pericardial effusion or ascites requiring repeated drainage;
  • Participants diagnosed with active hepatitis B [hepatitis B surface antigen (HBsAg) positive, with HBV-DNA ≥ 500 IU/mL or above the lower limit of quantification, whichever is higher] or hepatitis C (positive anti-HCV antibody with HCV-RNA above the lower limit of quantification);
  • Participants with poorly controlled known human immunodeficiency virus (HIV) infection, including HIV-infected individuals with a history of Kaposi's sarcoma and/or multicentric Castleman's disease;
  • Participants with known active tuberculosis;
  • Participants with documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal disorders that hinder or delay corneal wound healing;
  • Participants who have undergone major surgery (as defined by the investigator) within 30 days before the first study dose or are still recovering from prior surgery;
  • Participants with known allergy or hypersensitivity to the study drug or its excipients, or a prior history of severe hypersensitivity reactions to monoclonal antibodies;
  • Participants with a history of interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid therapy, current ILD/pneumonia, or suspected ILD/pneumonia that cannot be ruled out by imaging at screening;
  • Participants with a history of allogeneic tissue or organ transplantation; Autoimmune diseases requiring systemic therapy within the past 2 years or anticipated immunosuppressive therapy during the study period. Participants with well-controlled type 1 diabetes, euthyroid thyroiditis, hypothyroidism adequately managed via hormone replacement therapy (HRT), or skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis) are eligible for enrollment;
  • Prior treatment with TROP2-targeted agents or any topoisomerase I inhibitors, including antibody-drug conjugates (ADCs);
  • Prior administration of any investigational anti-tumor vaccines or any agents targeting T-cell co-stimulatory pathways;
  • Vaccination with live vaccines within 30 days before the first study dose, or planned live vaccine administration during the study period;
  • Participants requiring strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 2 weeks prior to the first dose and throughout the study period. Concomitant use of strong CYP3A4 inhibitors or inducers is prohibited in this study; representative agents are listed in Appendix 7. All participants shall avoid concomitant use of any known CYP3A4-inducing medications, herbal supplements, and/or relevant foods to the greatest extent possible;
  • Receipt of any chemotherapy, radiotherapy, immunotherapy or biotherapy within 4 weeks before the first study dose; receipt of small-molecule tyrosine kinase inhibitors (TKIs), anti-tumor hormonal therapy, systemic immune stimulants (including but not limited to interferon, IL-2), or proprietary Chinese herbal medicines approved for anti-tumor indications within 2 weeks before the first study dose;
  • Palliative radiotherapy administered to known metastatic sites within 2 weeks before the first study dose;
  • Systemic anti-infective therapy received within 1 week before the first study dose;
  • Female participants who are pregnant or breastfeeding;
  • Diseases requiring systemic corticosteroid therapy (prednisolone equivalent dose >10 mg/day) or other immunosuppressants within 14 days before the first study dose. Participants receiving intranasal, inhaled, topical cutaneous, local injectable corticosteroids (e.g., intra-articular injection), or corticosteroids for hypersensitivity prophylaxis may be enrolled;
  • Any other conditions under which the investigator deems the participant unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Feng Wang, MD contact

+86 020 87343795

wangfeng@sysucc.org.cn

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Single-Arm, Multicenter Phase II Study of Sacituzumab Tirumotecan (Sac-TMT/SKB264) Combined With Tagitanlimab (KL-A167) as Second-Line Therapy for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma and Gastric/Gastroesophageal Junction Adenocarcinoma

This is a single-arm, multi-center phase II study to evaluate the efficacy and safety of sacituzumab tirumotecan (Sac-TMT/SKB264) combined with tagitanlimab (KL-A167) as 2nd line therapy for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) or gastric/gastroesophageal junction adenocarcinoma (G/GEJA). A total of 75 participants are planned to be enrolled with 10 in the safety lead-in phase and 33 ESCC and 42 G/GEJA in expansion phase, seperately.

Being tested
Sacituzumab Tirumotecan + Tagitanlimab
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • Sacituzumab Tirumotecan + TagitanlimabDrug

    Sac-TMT (SKB264): 4mg/kg, IV infusion on Day 1, Q2W A167: 900 mg via IV injection on day 1, Q2W, up to 2 years

Study groups in NCT07701681
Study groupRoleWhat they receive
Sac-TMT + A167ExperimentalNot described
Receives: Drug: Sacituzumab Tirumotecan + Tagitanlimab

What is being measured

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

  1. Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)

    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 reported.

    Measured: Up to 21 days

  2. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per 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)

  1. 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 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

  2. Progression-Free Survival (PFS)

    PFS is defined as the time from enrollment to the first documented progressive disease (PD) or death from any cause, whichever occurs first. 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. PFS as assessed by investigators will be presented.

    Measured: Up to ~2 years

  3. Disease Control Rate (DCR)

    DCR is defined as the percentage of participants in the analysis population who demonstrate a confirmed 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: No ≥30% decrease in the sum of target lesion diameters, and no ≥20% increase in the sum of target lesion diameters relative to the nadir sum of diameters, with no new lesions identified) per RECIST 1.1.

    Measured: Up to ~ 2 years

  4. Overall Survival (OS)

    OS is defined as the time from enrollment to the date of death from any cause.

    Measured: Up to ~ 5 years

  5. Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a 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.

  1. First posted14 Jul 2026
  2. Study start31 Aug 2026 (estimated)
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2029 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07701681
Sponsor's protocol ID
SKB264-IIT-028
Status last verified
Jul 2026
First submitted
8 Jul 2026
Last updated
14 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab Tirumotecan + Tagitanlimab in people with ESCC and Gastric Adenocarcinoma, run by Sun Yat-sen University at 1 site in China.

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 19 inclusion and 25 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 14 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 1 site in China. 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 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 Feng Wang, MD (+86 020 87343795, wangfeng@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) (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?

On the ClinicalTrials.gov record for NCT07701681.

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 14 Jul 2026.

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