SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma
NCT07700667 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-07-14
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 three parts: the safety run-in phase, randomized enrollment phase and cohort expansion phase.
Conditions
Interventions
- DRUG
-
SKB500
SKB500 will be administered as an intravenous infusion(IV), every 3 weeks on Day 1 of each 21-day cycle.
- DRUG
-
Tislelizumab will be administered as an intravenous infusion(IV) every 3 weeks on Day 1 of each 21-day cycle .
- DRUG
-
Cisplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
- DRUG
-
5 - FU
5-FU will be administered as an intravenous infusion(IV) every 3 weeks on Day 1-5 of each 21-day cycle.
Sponsors & Collaborators
-
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-30
- Primary Completion
- 2028-12-31
- Completion
- 2029-12-31
Countries
- China
Study Locations
More Related Trials
-
Phase II Study of Induction Chemoimmunotherapy Followed by Radiotherapy and Organ Preservation in Resectable ESCC
NCT07711470 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Second-line Cabozantinib and Atezolizumab in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
NCT05007613 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma
NCT04974047 ·Status: COMPLETED ·Phase: PHASE2
-
PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Subjects With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
NCT05007145 ·Status: UNKNOWN ·Phase: PHASE2
-
Carrelizumab Combined With Chemotherapy for Adjuvant Therapy of Esophageal Squamous Cell Carcinoma
NCT05637268 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
NCT03783442 ·Status: COMPLETED ·Phase: PHASE3
-
Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma
NCT05461794 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Efficacy of SCT200 in Head and Neck Squamous Cell Carcinoma
NCT03713372 ·Status: UNKNOWN ·Phase: PHASE2
-
A Phase II Study of PD-1/IL-2α-bias Bispecific Antibody Fusion Protein Monotherapy in Advanced Esophageal Squamous Cell Carcinoma After Failure of Prior ICI Plus Platinum-Based Chemotherapy
NCT07688291 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of IPM514 in Patients with Esophageal Squamous Cell Carcinoma
NCT06690476 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
KN046 in Subjects With Late Stage Esophageal Squamous Cell Carcinoma
NCT03925870 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer
NCT06194734 ·Status: RECRUITING ·Phase: PHASE3
-
Pembrolizumab Plus Paclitaxel, Cisplatin Followed by Surgery for Locally Advanced ESCC (KEYSTONE-001)
NCT04389177 ·Status: UNKNOWN ·Phase: PHASE2
-
Early Response-guided Sequential Radiotherapy After Chemoimmunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
NCT07721103 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Trial of the Combination of Afatinib and Palbociclib in Previously Treated Advanced Esophageal Squamous Cell Carcinoma
NCT06753747 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma
NCT06122493 ·Status: RECRUITING ·Phase: PHASE2
-
Tislelizumab Combined with Chemotherapy and All Trans Retinoic Acid for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
NCT06703047 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Tislelizumab Combined With Chemotherapy or Radiotherapy in the Treatment of Advanced or Recurrent Metastatic Elderly Esophageal Cancer
NCT05628610 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma
NCT05515315 ·Status: RECRUITING ·Phase: PHASE2
-
Low Dose Decitabine in Combination With Tirelizumab Comparison of Tirelizumab in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma
NCT05638984 ·Status: UNKNOWN ·Phase: PHASE2
-
Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer
NCT06173986 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC
NCT05469061 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma
NCT03957590 ·Status: COMPLETED ·Phase: PHASE3
-
SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma.
NCT05022654 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
NCT06010303 ·Status: COMPLETED ·Phase: PHASE2