A Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma.

NCT06136988 | Not Yet Recruiting Phase 1

• 1 other identifier: HB1801-008
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 2

Brief Summary

The study is a multicenter, open-label, phase Ib/II study to evaluate the efficacy and safety of docetaxel for injection (albumin-bound) (HB1801) and SG001 in combination with cisplatin and simultaneous radiotherapy versus paclitaxel in combination with cisplatin and simultaneous radiotherapy for locally advanced unresectable esophageal squamous carcinoma.

Conditions

Locally Advanced Unresectable Esophageal Squamous Carcinoma

Outcome Measures

Primary Outcomes (4)

• Dose-limiting toxicity (DLT)

  At the end of Cycle 1 (each cycle is 21 days)

• Determine the recommended Phase 2 dose (RP2D) of Docetaxel for Injection (Albumin-bound)

  At the end of Cycle 2 (each cycle is 21 days)

• Incidence and frequency of adverse events (AE) and serious adverse events (SAE) in Phase Ib

  up to 4 years

• PFS as determined by the investigator according to RECIST 1.1 in Phase Ⅱ

  up to 4 years

Secondary Outcomes (7)

• Objective remission rate (ORR)

  up to 4 years

• Disease control rate (DCR)

  up to 4 years

• Duration of remission (DOR)

  up to 4 years

• Progression-free survival (PFS)

  up to 4 years

• Overall survival (OS)

  up to 4 years

Other Outcomes (3)

• Total docetaxel concentration in plasma and free docetaxel concentration

  up to 4 years

• SG001 concentration in serum

  up to 4 years

• To evaluate the correlation between PD-L1 expression and efficacy in tumor tissues

  up to 4 years

Study Arms (2)

HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy

EXPERIMENTAL

SG001 360 mg, Intravenous infusion, D1, Q3W, up to approximately 2 years ; Docetaxel for Injection (Albumin-bound) (HB1801), Intravenous infusion, D1, Q3W, 60 or 75 mg/m\^2, up to 2 cycles; cisplatin for injection 25 mg/m\^2, D1-D3, Q3W, up to 2 cycles; radiotherapy (28×1.8Gy).All treatments will be administered until disease progression or intolerable toxicity.

Drug: Docetaxel for Injection (Albumin-bound); Drug: SG001; Drug: Cisplatin for injection; Radiation: Simultaneous Radiotherapy

Paclitaxel in combination with cisplatin and simultaneous radiotherapy

ACTIVE COMPARATOR

Paclitaxel 135 mg/m\^2, Intravenous infusion, D1, Q3W; cisplatin for injection 25 mg/m\^2, D1-D3, Q3W, radiotherapy (28×1.8Gy). No other systemic antineoplastic therapy is allowed until disease progression, optimal supportive care and local palliative care are allowed.

Drug: Cisplatin for injection; Drug: Paclitaxel; Radiation: Simultaneous Radiotherapy

Interventions

Docetaxel for Injection (Albumin-bound) DRUG

Docetaxel for Injection (Albumin-bound) 60 or 75 mg/m\^2, Intravenous infusion, Q3W

Also known as: HB1801

HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy

SG001 DRUG

Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 360 mg, Intravenous infusion, Q3W

Also known as: Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection

HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy

Cisplatin for injection DRUG

Cisplatin for injection, 25 mg/m\^2, Intravenous infusion, D1-D3, Q3W

HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy; Paclitaxel in combination with cisplatin and simultaneous radiotherapy

Paclitaxel DRUG

Paclitaxel 135 mg/m\^2, Intravenous infusion, Q3W

Paclitaxel in combination with cisplatin and simultaneous radiotherapy

Simultaneous Radiotherapy RADIATION

Radiotherapy (28×1.8Gy)

HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy; Paclitaxel in combination with cisplatin and simultaneous radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years (based on the day of signing the informed consent form).
• Voluntarily sign the informed consent, willing and able to follow the protocol for visits, treatment and laboratory tests.
• Locally advanced (stage II-IVa and IVb supraclavicular lymph node metastases according to AJCC 8th edition) esophageal squamous carcinoma (in the case of mixed adenosquamous carcinoma, more than 50% squamous carcinoma component can be screened) diagnosed histologically or cytologically, which is unresectable in the judgment of the principal investigator, and is amenable to definitive chemoradiotherapy (dCRT) .
• ECOG score of 0-1 within 7 days prior to the first dose.
• Vital organ function within 7 days prior to first dose, meeting the following criteria (no blood transfusions, no use of human granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), and erythropoietin (EPO) within 14 days prior to the first dose):
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
• Platelet count (PLT) ≥ 100×10\^9/L
• Hemoglobin ≥ 80g/L
• Serum albumin ≥ 28g/L
• Total bilirubin ≤1.0×ULN; ALT/AST ≤1.5×ULN
• Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min, Cockcroft-Gault formula
• Activated Prothrombin Time (APTT) and International Normalized Ratio (INR) ≤ 1.5 x ULN.
• Female patients of childbearing age tested negative serum pregnancy test within 7 days prior to the first dose, and patients must agree to take effective contraception from the signing of the informed consent form until 6 months after the last dose, during which time breastfeeding is not allowed; male patients must agree to take contraception and sperm donation is not allowed.
• Have at least one evaluable lesion per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).

You may not qualify if:

• Active malignancy within 5 years prior to the first dose, except esophageal carcinoma studied in this trial and any locally curable tumor that has received radical therapy (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or early-stage thyroid cancer, etc).
• History of esophageal perforation and/or esophageal fistula within 6 months prior to the first dose; or significant tumor invasion into an organ adjacent to the esophageal lesion (aorta or trachea), etc., resulting in a high risk of hemorrhage, esophageal fistula, or signs of esophageal perforation.
• Uncontrollable plasma effusions requiring frequent drainage or medical intervention (e.g., pleural effusion, peritoneal effusion, pericardial effusion, etc.) within 7 days prior to the first dose that require additional interventions within 2 weeks of the intervention (excluding exfoliative cytology of the exudate).
• Weight loss of 20% or more within 3 months prior to the first dose; or BMI \<18.5 kg/m\^2 and/or weight \<30 kg.
• Severe allergy history to albumin or docetaxel, paclitaxel, cisplatin, or monoclonal antibody drugs.
• Patients who have received prior antitumor therapy for esophageal cancer.
• Patients with immunodeficiency or active autoimmune disease (except a. well-controlled type I diabetes b. hypothyroidism \[controlled with hormone replacement therapy\] c. well-controlled celiac disease d. dermatologic that do not require systemic therapy \[e.g., vitiligo, psoriasis, alopecia\] e. any other condition not expected to recur in the absence of external triggers).
• History of severe cardiovascular disease within 6 months prior to the first dose, including but not limited to:
• Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, Third-degree atrioventricular block
• History of myocardial infarction, unstable angina, angioplasty, coronary artery bridging surgery
• Heart failure with New York Heart Association (NYHA) classification of class III and above
• Left ventricular ejection fraction (LVEF) \<50% at screening period
• Patients with prolonged QT/QTc interval on ECG at baseline (QTcF \> 480ms, Fridericia formula: QTcF=QT/RR\^0.33, RR=60/heart rate).
• Patients with poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg during the screening period).
• Patients with active Hepatitis B (Hepatitis B surface antigen (HBsAg) or HBcAb positive test and active stage of Hepatitis B (HBV-DNA ≥ 10\^4 cps/mL or ≥ 2000 IU/mL)); Hepatitis C (Hepatitis C Antibody (Anti-HCV) positive test and a positive PCR result for HCV RNA); positive for HIV, during the screening period.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (2)

Shandong Tumor Hospital

Jinan, Shandong, China

Location

Tianjin cancer institute &hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Interventions

Docetaxel; Injections; Cisplatin; Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

+86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (2)