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Esophageal Squamous Cell CarcinomaPhase 2NCT07700667

SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma

A Phase 2 study testing SKB500, Tislelizumab and Cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 24 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with Esophageal Squamous Cell Carcinoma. The study is divided into two parts: the safety run-in phase and the cohort expansion phase. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
SKB500, Tislelizumab and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
24 sitesChina
Study dates
13 Aug 2026to 31 Dec 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years and ≤75 years
  • Histologically or cytologically confirmed unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), who are ineligible for curative-intent therapies:
  • Safety run-in phase (Cohort 1, 2 and 3): received no more than 1 prior line of systemic therapy for locally advanced or metastatic ESCC.
  • Safety run-in phase (Cohort 4) and cohort expansion phase: no prior systemic therapy for locally advanced or metastatic ESCC.
  • Participants are required to provide tumor tissue samples for biomarker analysis.
  • Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 12 weeks.

Who cannot join

  • Histology or cytology confirms the presence of concurrent adenocarcinoma components.
  • Leptomeningeal, brainstem, spinal, spinal cord compression, or active CNS metastases.
  • Risk of esophagotracheal/esophagopleural fistula, or symptomatic invasion/compression of vital organs/major blood vessels.
  • Active autoimmune disease requiring systemic therapy within past 2 years.
  • Weight loss ≥10% within 4 weeks prior to the first dose, or Nutritional Risk Index (NRI) < 83.5.
  • Severe infection within 4 weeks or active infection requiring systemic treatment within 2 weeks pre-dose.
Show all 14Show fewer
  • Uncontrolled comorbidities (e.g., decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, Grade ≥2 peripheral neuropathy).
  • Cardiovascular/cerebrovascular events within 6 months pre-dose (e.g., Myocardial Infarction, unstable angina, acute/persistent ischemia, Grade 3/4 Heart Failure, symptomatic/uncontrolled arrhythmia, Cerebrovascular Accident, Transient Ischemic Attack).
  • Uncontrolled hypertension, diabetes, or recurrent pleural/pericardial/abdominal effusion requiring drainage.
  • History of interstitial lung disease (ILD) or noninfectious pneumonitis that require steroid treatment, or currently has ILD/noninfectious pneumonitis.
  • Unresolved to grade ≤ 1 of prior anti-cancer treatment toxicities criteria per CTCAE v6.0.
  • Previously received B7-H3-targeted agents, including antibody, antibody-drug conjugate (ADC), and other agents.
  • Previously received any agent containing a topoisomerase I inhibitor (including chemotherapy and antibody-drug conjugate(ADC)).
  • Pregnant or lactating women.

Trial locations and contacts

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

Qing Yan contact

028-67255480

qingyan@kelun.com

24 sites in 1 country

China24 sites, 24 recruiting

  • Jilin Cancer Hospital

    Changchun

    Recruiting

  • Chengdu Fifth People's Hospital

    Chengdu

    Recruiting

  • Sichuan Cancer Hospital & Institute

    Chengdu

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu

    Recruiting

  • Chongqing University Three Gorges Hospital

    Chongqing

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Recruiting

  • Harbin Medical University Cancer Hospital

    Ha’erbin

    Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan

    Yu Jinming, 0531-67626063, sdyujinming@126.com

    Recruiting

  • Yunnan Cancer Hospital

    Kunming

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing

    Recruiting

  • Jiangsu Province Hospital

    Nanjing

    Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning

    Recruiting

  • Cancer Hospital of Shantou University Medical College

    Shantou

    Recruiting

  • Cancer Hospital of Dalian University of Technology

    Shenyang

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang

    Recruiting

  • Shiyan Renmin Hospital

    Shiyan

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Recruiting

  • Yichang Central People's Hospital

    Yichang

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Recruiting

Other trials in China

About this study

Official title: A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma

The purpose of this study is to evaluate the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with Esophageal Squamous Cell Carcinoma. The study is divided into two parts: the safety run-in phase and the cohort expansion phase.

Read the detailed description

This is a Phase II, multicenter, open-label study to evaluate the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with Esophageal Squamous Cell Carcinoma. The study is divided into two parts: the safety run-in phase and the cohort expansion phase.

Being tested
SKB500, Tislelizumab, Cisplatin, 5 - FU
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.

  • SKB500Drug

    SKB500 will be administered as an intravenous infusion(IV), every 3 weeks on Day 1 of each 21-day cycle.

  • TislelizumabDrug

    Tislelizumab will be administered as an intravenous infusion(IV) every 3 weeks on Day 1 of each 21-day cycle .

  • CisplatinDrug

    Cisplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

  • 5 - FUDrug

    5-FU will be administered as an intravenous infusion(IV) every 3 weeks on Day 1-5 of each 21-day cycle.

Study groups in NCT07700667
Study groupRoleWhat they receive
Cohort 1. SKB500+TislelizumabExperimentalParticipants will receive Tislelizumab followed by SKB500
Receives: Drug: SKB500; Drug: Tislelizumab
Cohort 2. SKB500+Tislelizumab+5-FUExperimentalParticipants will receive Tislelizumab followed by SKB500, 5-FU
Receives: Drug: SKB500; Drug: Tislelizumab; Drug: 5 - FU
Cohort 3. SKB500+Tislelizumab+ CisplatinExperimentalParticipants will receive Tislelizumab followed by SKB500, Cisplatin
Receives: Drug: SKB500; Drug: Tislelizumab; Drug: Cisplatin
Cohort 4. SKB500+Tislelizumab+ Cisplatin+5-FUExperimentalParticipants will receive Tislelizumab followed by SKB500, Cisplatin, 5-FU
Receives: Drug: SKB500; Drug: Tislelizumab; Drug: Cisplatin; Drug: 5 - FU

What is being measured

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

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by investigator based on RECIST version 1.1.

    Measured: up to 24 months

  2. Incidence and severity of adverse events (AEs) and serious adverse event(SAEs)

    Incidence and severity of adverse events (AEs) and serious adverse event(SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v6.0, as well as clinically significant abnormal laboratory findings.

    Measured: up to 24 months

Secondary outcomes (7)

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) was defined as the time from baseline to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.

    Measured: up to 24 months

  2. Duration of response (DOR)

    Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response[CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DOR was measured for responding participants (PR or CR) only.

    Measured: up to 24 months

  3. Disease control rate (DCR)

    Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate.

    Measured: up to 24 months

  4. Overall Survival (OS)

    The time from first dose to death from any cause.

    Measured: up to 24 months

  5. Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of SKB500-ADC, SKB500-TAB and free payload

    Cycle 1, 2, 4, 6, 8: pre-dose, post-dose; 12,16, every 8 cycles starting from Cycle 16 Day 1: pre-dose(each cycle is 21 days).

    Measured: up to 24 months

  6. Pharmacokinetic Parameter Minimum Plasma Concentration (Cmin) of SKB500-ADC, SKB500-TAB and free payload

    Cycle 1, 2, 4, 6, 8: pre-dose, post-dose; 12,16, every 8 cycles starting from Cycle 16 Day 1: pre-dose(each cycle is 21 days) .

    Measured: up to 24 months

  7. Anti-drug Antibodies (ADA) for SKB500

    Cycle 1, 2, 4, 8, every subsequent 8 cycles starting from Cycle 8 Day 1 : pre-dose (each cycle is 21 days).

    Measured: up to 24 months

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 start13 Aug 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07700667
Sponsor's protocol ID
SKB500-Ⅱ-04
Status last verified
Jul 2026
First submitted
8 Jul 2026
Last updated
20 Oct 2026
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 SKB500, Tislelizumab and Cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 24 sites 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 8 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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 Qing Yan (028-67255480, qingyan@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: up to 24 months). 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 NCT07700667.

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 20 Oct 2026.

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