Efficacy and Safety Study of First-line Treatment With SG001 Plus Chemotherapy ± Bevacizumab Versus Placebo Plus Chemotherapy ±Bevacizumab for Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)

NCT05715840 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: SYSA1802-007
• Study Type: interventional
• Target: 368
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy±bevacizumab versus placebo plus chemotherapy±bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS≥1), Recurrent or Metastatic Cervical Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of SG001＋Chemotherapy±Bevacizumab will be assessed prior to the Phase 3 portion of the study.

Conditions

Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)

Outcome Measures

Primary Outcomes (3)

• Safety Lead-in

  Incidence and grade of the TRAE、SAE and irAE

  Up to 42 days after the last patient of the lead-in phase

• PFS per RECIST 1.1

  Phase 3

  Up to approximately 3 years

• Overall survival (OS)

  Phase 3

  Up to approximately 3 years

Secondary Outcomes (11)

• Safety Lead-in and phase 3

  Up to approximately 3 years

• Peak Plasma Concentration（Cmax）

  Up to approximately 2 years

• DOR per RECIST 1.1

  Up to approximately 3 years

• DCR per RECIST 1.1

  Up to approximately 3 years

• TTR per RECIST 1.1

  Up to approximately 3 years

Study Arms (2)

safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab

EXPERIMENTAL

SG001 360 mg, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m\^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m\^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity

Drug: SG001 injection; Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Drug: Bevacizumab injection

Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab

PLACEBO COMPARATOR

Placebo, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m\^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m\^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity

Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Drug: Bevacizumab injection; Drug: SG001 placebo

Interventions

SG001 injection DRUG

360 mg，Q3W，IV infusion

safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab

Paclitaxel DRUG

175 mg/m\^2，Q3W，IV infusion

Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab; safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab

Cisplatin DRUG

50 mg/m\^2，Q3W，IV infusion

Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab; safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab

Carboplatin DRUG

AUC=5，Q3W，IV infusion

Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab; safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab

Bevacizumab injection DRUG

15 mg/kg，Q3W，IV infusion

Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab; safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab

SG001 placebo DRUG

Q3W，IV infusion

Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 and ≤ 70 on the day of signing informed consent and volunteered to participated in this study.
• Has histologically documented recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation).
• (Safety Lead-in)Has a measurable lesion per RECIST 1.1 via CT or MRI. (Phase 3) Has a assessable lesion per RECIST 1.1 via CT or MRI.
• Has provided enough archival tumor tissue sample or willing to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to first dose.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to first dose.
• Has a predicted survival period ≥ 3 months assessed by investigators.
• Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0.
• Adequate organ function as defined below:
• Blood routine tests (No blood transfusions and hematopoietic stimulators have been used, and no drugs have been used to correct blood cell counts ): Absolute neutrophil count (ANC) ≥1.5×10\^9/L; Platelets ≥100 ×10\^9/L; Hemoglobin (HGB)≥9 g/dL;
• Serum biochemical indexs: Serum creatinine ≤1.5 × ULN or \>1.5 × ULN with creatinine clearance (CCr) ≥ 60 mL/min; Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Patients with Gilbert's syndrome can be up to 3 × ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 X ULN for patients with liver metastases;
• Coagulation function: Activated partial thromboplastin time (APPT) and International Normalized Ratio (INR)≤1.5 × ULN (No anticoagulants or other drugs affecting clotting function have been used within 14 days prior to the first dose, except for patients requiring long-term anticoagulant therapy).

You may not qualify if:

• Active malignancy within 2 years prior to first dose of the investigational drug, except for cervical cancer 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, cervical cancer in situ, breast cancer in situ, etc).
• History of primary immunodeficiency.
• History of active tuberculosis.
• Patients with any active autoimmune disease, except for patients with well-controlled type I diabetes, well-controlled hypothyroidism with hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or hair loss) without systemic treatment, or those who are not expected to relapse without external triggers.
• Serious cardiovascular disease within 6 months prior to the first dose, including but not limited to: stable angina with functional class III-IV; unstable angina or myocardial infarction; NYHA grade III-IV congestive heart failure; severe arrhythmias requiring drug therapy (congestive heart failure allowed if ventricular rate can be controlled; severe arrhythmias requiring drug therapy (congestive heart failure is allowed if the ventricular rate can be controlled).
• History of interstitial lung disease, or non-infectious pneumonitis requiring glucocorticoid therapy.
• Patients with active soft meningeal disease or poorly controlled brain metastasis.
• Prior therapy with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways including anti-PD-1, anti-PD-L1, anti-PD-L2, anti CTLA-4, OX40 agonist, and anti-CD137, etc.
• Has received prior radiotherapy within 14 days prior to the first dose.
• Has received prior chemosensitizer within 14 days prior to the first dose.
• Presence of clinically significant hydronephros which cannot be relieved by ventriculostomy or ureteral stent placement assessed by investigator.
• Patients with un-controlled pleural effusion, pericardial effusion or seroperitoneum requiring repeated drainage.
• Has any active infection requiring systemic treatment by intravenous infusion within 14 days prior to the first dose.
• Has received systemic corticosteroids (at doses equivalent to or greater than 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose.
• Have received major surgery, open biopsy or traumatism within 28 days before the first dose, or planned to receive elective major surgery during the study period.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Recurrence

Interventions

Paclitaxel; Cisplatin; Carboplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lingying Wu, M.D

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fenglin She, MSc

CONTACT

010-63942533; shefenglin@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 8, 2023
• Study Start: January 31, 2023
• Primary Completion: July 31, 2024
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 8, 2023

Record last verified: 2023-01