A Phase 2 Clinical Study of Evaluation of Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection (609A) Combined With Doxorubicin Hydrochloride in the Treatment of Metastatic/Unresectable Non-specific Soft Tissue Sarcoma

NCT05138146 | Unknown Phase 2

• 1 other identifier: SSGJ-609A-ADM-STS-II-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, open label, phase 2 study aimed to evaluate the efficacy and safety of the combination recombinant anti-PD-1 humanized monoclonal antibody injection (609A) and doxorubicin hydrochloride in the treatment of metastatic/unresectable non-specific soft tissue sarcoma

Conditions

Sarcoma, Soft Tissue

Outcome Measures

Primary Outcomes (3)

• Recommended phase II dose (RP2D) (Part 1)

  RP2D of the combination 609A and doxorubicin hydrochloride.

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

• Adverse events (Part 1)

  Evaluate the safety of the combinations According to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) .

  up to 2 years.

• Objective Response Rate (ORR) (part 2)

  Evaluated per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT. Complete Response (CR) is a complete elimination of the tumor; Partial Response (PR) is 30% reduction. If a subject experienced a PR, this was required to be confirmed with a second scan at the next appropriate cycle.

  Up to 2 years .

Secondary Outcomes (8)

• Objective Response Rate (ORR) (part 1)

  Up to 2 years.

• Adverse events (Part 2)

  Up to 2 years.

• Maximum Plasma Concentration (Cmax) (Part 2)

  Up to 2 years.

• Area Under the Curve (AUC) (Part 2)

  Up to 2 years.

• Median Progression-free Survival (PFS) (Part 1+2)

  Up to 2 years .

Study Arms (1)

experimental group

EXPERIMENTAL

609A combined with doxorubicin hydrochloride

Drug: 609A; Drug: doxorubicin hydrochloride

Interventions

609A DRUG

609A 200mg,IV, Day 1of each treatment cycle, up to disease progression or intolerable toxicity, death, early withdrawal from the study or loss to follow-up, withdrawal of consent, or the end of the treatment period, whichever occurs first. Every 3 weeks a treatment cycle.

experimental group

doxorubicin hydrochloride DRUG

60mg/m2 or 75mg/m2, IV, Day1of the1-6th treatment cycles only. Every 3 weeks a treatment cycle.

experimental group

Eligibility Criteria

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

You may qualify if:

• Able to understand and voluntarily sign an informed consent form;
• Age ≥ 18 years old when signing the informed consent form, regardless of gender;
• Agree to provide biopsy tissue samples or archived tumor tissue samples (part 1 is voluntary);
• Unresectable (including patients who refuse surgical resection) or metastatic unspecified soft tissue sarcoma confirmed by histology/cytology (subtypes allowed to be included include: synovial sarcoma, mucinous/round cell liposarcoma , Uterine leiomyosarcoma, pleomorphic liposarcoma, myxofibrosarcoma, epithelioid sarcoma, pleomorphic rhabdomyosarcoma, leiomyosarcoma, malignant peripheral nerve sheath tumor, angiosarcoma, scalp and facial angiosarcoma, dedifferentiated liposarcoma) patients ；
• Patients who have not received systemic drug therapy in the past;
• According to the RECIST V1.1 solid tumor efficacy evaluation standard, the patient has at least one imaging measurable lesion;
• ECOG score 0 or 1;
• Expected lifetime ≥ 3 months;
• The organ function level must meet the following requirements:
• The absolute value of neutrophils (ANC) ≥ 1.5×109/L; platelet count (PLT) ≥100×109/L; hemoglobin (Hb) ≥90 g/L or ≥5.6 mmol/L (not accepted within 14 days) Blood transfusion, albumin or use of EPO, G-CSF);
• Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 × ULN (for patients with primary liver sarcoma or liver metastases, TBIL is allowed ≤ 3×ULN, AST and/or ALT ≤ 5×ULN), albumin (ALB) ≥ 2.5 mg/dL;
• Serum creatinine (Cr) ≤ 1.5×ULN or estimated creatinine clearance (CrCl) ≥ 60 mL/min (Cockroft and Gault formula);
• International normalized ratio (INR) ≤ 1.5×ULN; partial activated thromboplastin time (APTT) ≤ 1.5×ULN.
• Female and male patients during the reproductive period need to agree to adequate contraception (such as abstinence, intrauterine device, contraceptives or condoms) during the study period and 6 months after the last dose.

You may not qualify if:

• Received radiotherapy covering more than 30% of the bone marrow area or carried out large-area irradiation within 4 weeks before the first administration (palliative radiotherapy for bone or palliative radiotherapy for superficial lesions is allowed, and it has ended 14 days before the first administration );
• Received Chinese medicine or Chinese medicine preparation with anti-tumor as indication within 2 weeks or 5 half-life period (whichever is the elder) before the first administration;
• Those who have participated in and received clinical trials of investigational drugs or interventional devices 4 weeks before the first administration or at least 5 half-lives of the drug (whichever is the elder);
• Vaccination with live attenuated vaccine within 4 weeks before the first administration (seasonal influenza vaccine for injection is generally an inactivated vaccine, which is allowed to be used; while intranasal influenza vaccine \[such as flu spray\] is a live attenuated vaccine, which is not Allowed)
• Use moderate or strong CYP3A4, P-glycoprotein, CYP2D6 inhibitors and CYP3A4, P-glycoprotein inducers within 1 week before the first administration;
• Any toxicity related to previous radiotherapy has not recovered to ≤ Grade 1 (except for hair loss or treatment-related Grade 2 peripheral neuropathy);
• Patients with active central nervous system (CNS) metastasis and/or cancerous meningitis found in a known or screening phase examination;
• Spinal cord compression that has not been cured by surgery and/or radiotherapy;
• Accompanied by unstable pleural effusion or ascites or pericardial effusion with obvious symptoms (those with stable clinical symptoms after treatment with pleural effusion or ascites or pericardial effusion can be included in the group);
• Those who have a history of other malignant tumors, except for malignant tumors that have undergone radical resection and have not recurred within 5 years after surgery, such as cervical carcinoma in situ and skin basal cell carcinoma;
• Anyone who has been allergic to protein drugs or recombinant proteins or excipients in 609A pharmaceutical preparations in the past;
• People with active tuberculosis (tuberculous bacilli);
• Those who have a history of non-infected pneumonia in the past or who are currently suffering from pneumonia;
• Accompanied by immunodeficiency or active autoimmune disease (in the past 2 years, systemic glucocorticoid systemic treatment with \>10 mg/day prednisone or its equivalent is required, but alternative therapies such as thyroxine, Insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency is not considered a form of systemic therapy and can be admitted to the group), and those who have used any other form of immunosuppressant within 14 days before the first administration ( The use of physiological doses of glucocorticoids can be approved after inquiring the sponsor);
• Those who have received organ or bone marrow transplant in the past;

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (1)

Beijing ji shui tan Hospital

Beijing, Beijing Municipality, 100035, China

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Xiaohui Niu, Bachelor of Medicine

CONTACT

010-58516506/7161; niuxiaohui@263.net

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: November 14, 2021
• First Posted: November 30, 2021
• Study Start: December 30, 2021
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2024
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)