A Study to Evaluate the Efficacy and Safety of SG001 in Combination With Nab-Paclitaxel in Patients With Advanced Triple-Negative Breast Cancer (TNBC)

NCT05068141 | Unknown Phase 2

• 1 other identifier: SYSA1802-CSP-006
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and safety of SG001 in combination with Nab-paclitaxel in patients with advanced TNBC.

Conditions

Triple Negative Breast Cancer

Keywords

Triple negative breast cancer (TNBC)

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR will be assessed by RECIST 1.1 criteria.

  Up to approximately 2 years

Secondary Outcomes (14)

• Progression-free survival (PFS)

  Up to approximately 2 years

• Duration of response (DOR)

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

• Progression free survival (PFS) in patients with combined positive score (CPS) ≥ 10

  Up to approximately 2 years

Other Outcomes (1)

• Correlation between clinical characteristics and efficacy

  Up to approximately 2 years

Study Arms (1)

SG001 plus Nab-Paclitaxel

EXPERIMENTAL

Patients will receive SG001 intravenously at a dose of 240 mg on Days 1 and 15 of every 4-week cycle in combination with nab-paclitaxel at a dose of 100 mg/m\^2 on Days 1, 8, and 15 of every 4-week cycle until disease progression, or unacceptable toxicity, or other discontinuation or termination criteria are met.

Drug: SG001; Drug: Nab-paclitaxel

Interventions

SG001 DRUG

Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 240 mg, i.v., q2w

SG001 plus Nab-Paclitaxel

Nab-paclitaxel DRUG

Paclitaxel for Injection (Albumin Bound), 100 mg/m\^2, i.v., D1, D8, D15 of every 4-week cycle

SG001 plus Nab-Paclitaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients, aged 18-70 years (inclusive), voluntarily join the study and sign the informed consent form.
• Eastern Cooperative Oncology Group (ECOG) (ECOG): 0 \~ 1 point;
• Histologically confirmed TNBC, namely, human epidermal growth receptor 2-negative (HER2-negative) and estrogen receptor-negative (ER-negative) and progesterone receptor-negative (PR-negative); Patients with confirmed TNBC metastatic lesions are eligible.
• Patients with locally advanced (staging according to AJCC 8th Edition) inoperable or recurrent/metastatic TNBC who have received ≤ 1-line system treatment. The number of treatment-naïve patients and the pre-treated patients should be approximately in equal numbers. The interval ≥ 6 months between the end of taxane-based adjuvant/neoadjuvant therapy and the occurrence of recurrence/metastasis, and an interval ≥ 3 months between the end of taxane-based therapy for advanced breast cancer and the occurrence of recurrence/metastasis.
• Provide archived tissue for detecting the expression level of PD-L1, or if not available, agree to perform a tumor tissue biopsy for PD-L1 detection during the screening period.
• The proportion of patients with CPS ≥ 10 should be ≥ 20% and ≤ 50% of all patients;
• The archived tissue must be representative of the latest tumor specimen, and the relevant pathological reports of the above specimens must also be provided;
• Fresh tissue specimens can be obtained by surgical resection and biopsy; Fine needle aspiration and liquid based cytology (TCT) samples are not accepted (i.e. samples lacking complete tissue structure and providing only cell suspension and/or cell smear);
• For patients with negative PD-L1 in the initially archived tumor tissue samples, biopsy can be performed during screening period to redetect the expression status of PD-L1 with the consent of the patients, and a positive tumor tissue sample of any kind is considered PD-L1 positive (i.e. CPS ≥ 1);
• At least one measurable lesion confirmed by CT or MRI at baseline as per the solid tumor efficacy evaluation criteria (RECIST v1.1). The measurable lesions should not have received local treatment such as radiotherapy (lesions located in the previous radiotherapy area can also be selected as target lesions if progression is confirmed);
• Estimated survival time ≥ 12 weeks;
• Adequate organ function, defined by the following laboratory results obtained within 14 days prior to the enrollment::
• Blood routine (no blood transfusion within 14 days before the first administration, no hematopoietic stimulating factor and no other drugs to correct the number of blood cells): neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count (PLT) ≥ 75 × 109/L; Hemoglobin (HGB) ≥ 9 g/dL;
• Blood biochemistry: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCR) ≥ 50 mL/min; Total bilirubin (TBIL) ≤ 1.5 × ULN (≤ 3 × ULN for patients with Gilbert's syndrome); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN for patients with hepatocellular carcinoma or liver metastasis);
• Coagulation function: activated partial thromboplastin time (APTT) and international standardized ratio (INR) ≤ 1.5 × ULN (not corrected with anticoagulants or other drugs affecting coagulation function within 14 days before the first dose, except for the long-term use of anticoagulants due to the patient's disease);

You may not qualify if:

• Known hypersensitivity to recombinant anti-PD-1 all human monoclonal antibody drugs and its components, or known allergy to any paclitaxel or albumin bound paclitaxel component; A history of uncontrollable allergic asthma;
• Previously diagnosed other malignancies within 3 years prior to screening, except for adequately treated skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, thyroid cancer or cured in situ carcinoma, such as cervical carcinoma in situ;
• Patients with active autoimmune disease or history of autoimmune disease, except for well-controlled type I diabetes, well-controlled hypothyroidism only requiring hormone replacement therapy, skin disease that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia), or patients whose diseases are not expected to recur in the absence of external triggers;
• Patients with a history of primary immunodeficiency;
• Patients with serious cardiovascular diseases, such as heart failure rated as grade 2 or above by the New York Heart Association (NYHA) classification, myocardial infarction within 3 months before screening, poorly controlled arrhythmia or unstable angina pectoris, or serious arterial/venous thrombotic events (such as transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep vein thrombosis and pulmonary embolism, etc.) within 3 months prior to screening;
• Interstitial lung disease requiring systemic therapy of glucocorticoid;
• Known untreated central nervous system (CNS) metastasis and meningeal metastasis, or treated but still symptomatic CNS metastasis and meningeal metastasis; However, asymptomatic untreated CNS metastasis and meningeal metastasis, and treated and symptomatically stable CNS metastasis and meningeal metastasis can be included.
• Have received any other antibodies/drugs that act on T-cell co-stimulation or checkpoint pathway (including but not limited to PD-1, PD-L1, PD-L2, CTLA-4, OX40, c137 inhibitors, etc.);
• Major surgery within 28 days before the first dose of study treatment, radiotherapy within 14 days before the first dose of study treatment, or use of radiation agents (strontium, or samarium, etc.) within 56 days before the first administration;
• Systemic antitumor therapy within 14 days before the first administration;
• Patients who have received live attenuated vaccine within 28 days before the first administration or planned to receive it during the study period.
• Any Chinese patent medicine treatment with an approved antitumor indication by NMPA or Chinese herbal medicine treatment for the purpose of antitumor which is clearly recorded in the medical record within 14 days before the first administration;
• Active tuberculosis;
• Active infection requiring intravenous infusion treatment within 14 days before the first administration;
• Received glucocorticoid (prednisone \> 10 mg/day or equivalent dose of other similar drugs) or other immunosuppressive treatment for some conditions within 14 days before the first administration;

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• herui yao

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY CHAIR

• wang ying

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

beibei Zhai

CONTACT

+86-021-60673937; zhaibeibei@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 5, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

CN (1)