Triple Negative Breast CancerPhase 2NCT05068141

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

A Phase 2 study testing SG001 and Nab-paclitaxel in people with Triple Negative Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Triple Negative Breast Cancer
What is being tested?: SG001 and Nab-paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 1 siteChina
Study dates: 1 Oct 2021to 1 Oct 2023
Phase: Phase 2
Are there results?: None posted in the registry

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 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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);
Women of childbearing age must take adequate contraceptive measures from the signing of informed consent to 6 months after the last dose.

Who cannot join

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;

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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;
Those who have received other test drugs within 28 days before the first administration;
Human immunodeficiency virus antibody (HIV-Ab) or treponema pallidum antibody (TP-AB) positive; Hepatitis B virus surface antigen (HBsAg) positive and/or hepatitis B core antibody (HBcAb) positive, with hepatitis B virus quantitative detection value > upper limit of normal (ULN) value of the detected center; Hepatitis C antibody (HCV-Ab) positive, with hepatitis B virus RNA quantification > ULN value of the detected center.
Pregnant or lactating women; Or positive test for blood pregnancy during screening;
Other situations that may increase the risks related to the study medication, interfere with the interpretation of the study results, affect compliance of the trial, etc. are determined by the investigator to be not suitable for the trial.

Trial locations and contacts

1 site in 1 country.

beibei Zhai contact

+86-021-60673937

zhaibeibei@mail.ecspc.com

China1 site, 1 recruiting

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
herui yao, M.D, +86-020-81332199, yaoherui@163.com
ying wang, M.D, +86-020-81332199, yingwang1101@126.com
Recruiting

Other trials in China

About this study

Official title: 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)

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.

Read the 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.

Conditions: Triple Negative Breast Cancer
Being tested: SG001, Nab-paclitaxel
Keywords: Triple negative breast cancer (TNBC)
Medical subject headings: Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SG001Drug
Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 240 mg, i.v., q2w
Nab-paclitaxelDrug
Paclitaxel for Injection (Albumin Bound), 100 mg/m^2, i.v., D1, D8, D15 of every 4-week cycle

Study groups in NCT05068141
Study group	Role	What they receive
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. Receives: Drug: SG001; Drug: Nab-paclitaxel

What is being measured

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

Objective response rate (ORR)
ORR will be assessed by RECIST 1.1 criteria.
Measured: Up to approximately 2 years

Secondary outcomes (14)

Progression-free survival (PFS)
Measured: Up to approximately 2 years
Duration of response (DOR)
Measured: Up to approximately 2 years
Disease control rate (DCR)
Measured: Up to approximately 2 years
Overall survival (OS)
Measured: Up to approximately 2 years
Progression free survival (PFS) in patients with combined positive score (CPS) ≥ 10
Measured: Up to approximately 2 years
Objective response rate (ORR) in patients with CPS ≥ 10
Measured: Up to approximately 2 years
Duration of response (DOR) in patients with CPS ≥ 10
Measured: Up to approximately 2 years
Disease control rate (DCR) in patients with CPS ≥ 10
Measured: Up to approximately 2 years
Overall survival (OS) in patients with CPS ≥ 10
Measured: Up to approximately 2 years
Treatment emergent adverse event (TEAEs)
Measured: Throughout the study period, with an average of 2 years
Maximum Serum Concentration (Cmax) for SG001 Maximum Serum Concentration for SG001 Maximum Serum Concentration (Cmax) for SG001
Maximum Serum Concentration for SG001
Measured: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Minimum Serum Concentration (Cmin) for SG001
Minimum Serum Concentration for SG001
Measured: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Plasma Concentrations of Total and Free Paclitaxel
Plasma Concentrations of Total and Free Paclitaxel
Measured: 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)
Immunogenicity
Anti-drug antibodies (ADA) and neutralizing antibodies
Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20211 Oct 2023

First posted5 Oct 2021
Study start1 Oct 2021
Primary completion1 Oct 2022 (estimated)
Study completion1 Oct 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 79 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05068141
Sponsor's protocol ID: SYSA1802-CSP-006
Status last verified: Oct 2021
First submitted: 9 Sep 2021
Last updated: 15 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT05068141
Acronym / sponsor ID: SYSA1802-CSP-006
Conditions: Triple Negative Breast Cancer
Keywords: Triple negative breast cancer (TNBC)
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 79 participants (estimated)
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 1 Oct 2021 (actual)
Primary completion: 1 Oct 2022 (estimated)
Study completion: 1 Oct 2023 (estimated)
First posted: 5 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SG001 plus Nab-Paclitaxel	Experimental	Drug: SG001, Drug: Nab-paclitaxelPatients 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.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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.

Key exclusion criteria (19 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SG001Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 240 mg, i.v., q2w	Drug	SG001 plus Nab-Paclitaxel
Nab-paclitaxelPaclitaxel for Injection (Albumin Bound), 100 mg/m^2, i.v., D1, D8, D15 of every 4-week cycle	Drug	SG001 plus Nab-Paclitaxel

Primary outcome

Objective response rate (ORR)
Time frame: Up to approximately 2 years
ORR will be assessed by RECIST 1.1 criteria.

14 secondary outcomes

Progression-free survival (PFS)
Time frame: Up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Progression free survival (PFS) in patients with combined positive score (CPS) ≥ 10
Time frame: Up to approximately 2 years
Objective response rate (ORR) in patients with CPS ≥ 10
Time frame: Up to approximately 2 years
Duration of response (DOR) in patients with CPS ≥ 10
Time frame: Up to approximately 2 years
Disease control rate (DCR) in patients with CPS ≥ 10
Time frame: Up to approximately 2 years
Overall survival (OS) in patients with CPS ≥ 10
Time frame: Up to approximately 2 years
Treatment emergent adverse event (TEAEs)
Time frame: Throughout the study period, with an average of 2 years
Maximum Serum Concentration (Cmax) for SG001 Maximum Serum Concentration for SG001 Maximum Serum Concentration (Cmax) for SG001
Time frame: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Minimum Serum Concentration (Cmin) for SG001
Time frame: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Plasma Concentrations of Total and Free Paclitaxel
Time frame: 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)
Immunogenicity
Time frame: Up to approximately 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

beibei Zhai contact

+86-021-60673937

zhaibeibei@mail.ecspc.com

herui yao study chair

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

wang ying study chair

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SG001 and Nab-paclitaxel in people with Triple Negative Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site 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 16 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact beibei Zhai (+86-021-60673937, zhaibeibei@mail.ecspc.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 approximately 2 years). 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 NCT05068141.

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 15 Oct 2021.