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Neuroendocrine Neoplasms (Tumours)Phase 2SKB264-II-NENNCT07077564

The Efficacy of TROP2-ADC in Advanced Extrapulmonary High-Grade Neuroendocrine Neoplasms Failure of Standard Therapy

A Phase 2 study testing Sac-TMT in people with Neuroendocrine Neoplasms (Tumours), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.

Not yet recruiting

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

Official record
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Trial summary

The response rate to second-line or later therapies for extrapulmonary high-grade neuroendocrine neoplasms (NENs) remains low, with no established standard treatment regimen. Patients exhibit short survival periods, with median overall survival ranging from 5.1 to 18 months, representing a significant unmet clinical… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neuroendocrine Neoplasms (Tumours)
What is being tested?
Sac-TMT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
No sites listed yet
Study dates
20 Jul 2025to 20 Jul 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide written informed consent and voluntarily participate in the study.
  • Aged 18-75 years, male or female.
  • Histologically or cytologically confirmed diagnosis of one of the following:
  • Metastatic neuroendocrine carcinoma (NEC) Neuroendocrine tumor (NET) Grade 3 (G3) Mixed neuroendocrine-non-neuroendocrine neoplasm (MiNEN) with >30% neuroendocrine component.
  • Progression after at least one prior line of systemic therapy.
  • ECOG Performance Status of 0 or 1.
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  • Life expectancy ≥3 months.
  • At least one measurable lesion per RECIST 1.1 at baseline:
  • Lesions must not have received prior local therapy (e.g., radiotherapy). Lesions within prior radiotherapy fields are acceptable if progression is documented.
  • Adequate organ function (no blood products/growth factors within 14 days prior):
  • Absolute neutrophil count (ANC) ≥1.5×10⁹/L
  • Platelets ≥100×10⁹/L ③Hemoglobin ≥8 g/dL ④Total bilirubin ≤1.5 × ULN ⑤ALT/AST ≤2.5 × ULN (≤5 × ULN if liver metastases present) ⑥Serum creatinine ≤1.5 × ULN or creatinine clearance >60 mL/min (Cockcroft-Gault formula).
  • 9. Contraception requirements:
  • Females of childbearing potential:
  • Negative serum pregnancy test within 72 hours prior to dosing. Use highly effective contraception (e.g., IUD, oral contraceptives, condoms) during and for ≥3 months after last dose.
  • Males with fertile partners:
  • Use effective contraception during and for ≥3 months after last dose.

Who cannot join

  • (1) Active CNS metastases and/or carcinomatous meningitis.
  • Exception: Subjects with treated brain metastases may enroll if: Stable for ≥28 days prior to study initiation, Off steroids for brain metastases ≥28 days. Note: Carcinomatous meningitis excluded regardless of stability.
  • Major surgery, open biopsy, or significant trauma within 28 days prior to first dose.
  • History of severe interstitial lung disease (ILD) with inadequate control. (4) Uncontrolled hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg despite antihypertensive therapy).
  • Poorly controlled cardiovascular disease, including:
  • NYHA Class II+ heart failure
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  • Unstable angina
  • Myocardial infarction within 1 year
  • Clinically significant supraventricular/ventricular arrhythmias refractory to intervention (6) Clinically significant bleeding within 3 months prior to first dose (e.g., GI bleeding, hemorrhagic gastric ulcer, vasculitis). (7) Arterial/venous thromboembolic events within 6 months prior to first dose (e.g., CVA, TIA, cerebral hemorrhage, DVT, PE).Exception: Superficial thrombosis per investigator assessment.
  • Active other malignancy requiring therapy. Exceptions: Non-melanoma skin cancer in situ with curative treatment.
  • (9)Pregnancy or lactation. (10)Other factors potentially leading to premature discontinuation per investigator judgment: Severe comorbidities (including psychiatric), Critical lab abnormalities, Social/familial factors compromising safety/data integrity (11)TROP2-targeted agents, ADC drugs (e.g., 8201)Topoisomerase I inhibitor-containing ADCs (12)Live vaccination within 30 days prior to first dose or planned during study.
  • (13)Requirement for strong CYP3A4 inhibitors/inducers within 2 weeks prior to first dose or during study.
  • Palliative radiotherapy to known metastatic sites within 2 weeks prior to first dose.
  • (15)Systemic anti-infective therapy within 1 week prior to first dose. Severe ocular conditions including: (16)Dry eye syndrome, Meibomian gland dysfunction, Blepharitis, Corneal disease delaying healing (17)Other exclusionary conditions per investigator assessment.

About this study

Official title: A Single-Center, Single-Arm, Phase II Clinical Trial of TROP2-ADC in Patients With Advanced Extrapulmonary High-Grade Neuroendocrine Tumors Refractory to Standard Therapy

The response rate to second-line or later therapies for extrapulmonary high-grade neuroendocrine neoplasms (NENs) remains low, with no established standard treatment regimen. Patients exhibit short survival periods, with median overall survival ranging from 5.1 to 18 months, representing a significant unmet clinical need. Sacituzumab govitecan has been evaluated in multiple clinical trials including OptiTROP-Breast01, KL264-01, OptiTROP-Lung01, OptiTROP-Lung03, and SKB264-Ⅱ-06. Current results consistently indicate promising efficacy of Sacituzumab govitecan in lung cancer, breast cancer, and cervical cancer. Notably, data presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting revealed that TROP2 is highly expressed in neuroendocrine tumors, and its expression is significantly associated with poor prognosis. This suggests TROP2-directed antibody-drug conjugates (ADCs) may demonstrate promising therapeutic potential in NENs.

Research Objective:To evaluate the efficacy of Sacituzumab govitecan in patients with advanced extrapulmonary neuroendocrine neoplasms who have progressed on standard therapies.

Being tested
Sac-TMT
Medical subject headings
Neoplasms

What participants receive

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

  • Sac-TMTDrug

    Sacituzumab govitecan 5 mg/kg every 2 weeks on Day 1 of each cycle（IV）

Study groups in NCT07077564
Study groupRoleWhat they receive
Sacituzumab govitecan 5 mg/kg every 2 weeks on Day 1 of each cycle（iv）ExperimentalNot described
Receives: Drug: Sac-TMT

What is being measured

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

  1. Objective Response Rate(ORR)

    The proportion of patients whose tumor volume has decreased to a pre-specified value (CR/PR) according to RECIST version 1.1 for solid tumors and can maintain the minimum required duration.

    Measured: 2 months

Secondary outcomes (3)

  1. Progression-Free Survival(PFS)

    Refers to the time from the start of randomization (or the start of treatment in a single-arm trial) until tumor progression or death due to any cause, whichever occurs first.

    Measured: 2 years

  2. Disease Control Rate (DCR)

    The proportion of patients with solid tumors (according to RECIST version 1.1) who achieve remission (PR+CR) and stable disease (SD) after treatment and can maintain the minimum required duration.

    Measured: 2 years

  3. Overall Survival(OS)

    Refers to the time from the start of randomization (or the start of treatment in a single-arm trial) until death due to any cause.

    Measured: 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 posted22 Jul 2025
  2. Study start20 Jul 2025 (estimated)
  3. Primary completion20 Jul 2027 (estimated)
  4. Study completion20 Jul 2028 (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
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07077564
Sponsor's protocol ID
2025-0615
Acronym
SKB264-II-NEN
Status last verified
Jul 2025
First submitted
10 Jul 2025
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sac-TMT in people with Neuroendocrine Neoplasms (Tumours), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.

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 17 inclusion and 14 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 22 Jul 2025. 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?

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?

Objective Response Rate(ORR) (time frame: 2 months). 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 NCT07077564.

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 22 Jul 2025.

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