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 Triple-Negative Breast Cancer (TNBC)

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 site in 1 country79 target enrollmentOctober 1, 2021

ConditionsTriple Negative Breast Cancer

InterventionsSG001 Nab-paclitaxel

DrugsSG001 Nab-paclitaxel

Overview

Phase: Phase 2
Intervention: SG001
Conditions: Triple Negative Breast Cancer
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Enrollment: 79
Locations: 1
Primary Endpoint: Objective response rate (ORR)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Detailed Description

This study 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 unresectable locally advanced, or recurrent, or metastatic TNBC. Eligible patients will receive SG001 intravenous infusion at a dose of 240 mg on Days 1 and 15 of every 4-week cycle and nab-paclitaxel intravenous infusion at a dose of 100 mg/m\^2 on Days 1, 8, and 15 of every 4-week cycle until disease progression, or intolerable toxicity, or other discontinuation or termination criteria are met, for a maximum of 2 years.

Registry

clinicaltrials.gov

Start Date

October 1, 2021

End Date

October 1, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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);

Exclusion Criteria

•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;

Arms & Interventions

SG001 plus Nab-Paclitaxel

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.

Intervention: SG001

SG001 plus Nab-Paclitaxel

Intervention: Nab-paclitaxel

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: Up to approximately 2 years

ORR will be assessed by RECIST 1.1 criteria.

Secondary Outcomes

Immunogenicity(Up to approximately 2 years)
Treatment emergent adverse event (TEAEs)(Throughout the study period, with an average of 2 years)
Plasma Concentrations of Total and Free Paclitaxel(Pre-dose on Cycle 1 Day 1. End of nab-paclitaxel infusion, 4 hours after end of nab-paclitaxel infusion on Day 1 and Day 15 of Cycle 1 (each cycle is 28 days))
Duration of response (DOR)(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)
Duration of response (DOR) in patients with CPS ≥ 10(Up to approximately 2 years)
Progression-free survival (PFS)(Up to approximately 2 years)
Objective response rate (ORR) in patients with CPS ≥ 10(Up to approximately 2 years)
Disease control rate (DCR) in patients with CPS ≥ 10(Up to approximately 2 years)
Disease control rate (DCR)(Up to approximately 2 years)
Overall survival (OS) in patients with CPS ≥ 10(Up to approximately 2 years)
Maximum Serum Concentration (Cmax) for SG001 Maximum Serum Concentration for SG001 Maximum Serum Concentration (Cmax) for SG001(Day 1 and Day 15 of Cycle 1 (each cycle is 28 days))
Minimum Serum Concentration (Cmin) for SG001(Day 1 and Day 15 of Cycle 1 (each cycle is 28 days))