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Soft Tissue Sarcoma

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609A combined with doxorubicin hydrochloride

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.

609A

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

doxorubicin hydrochloride

Xiaohui Niu, Bachelor of Medicine

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

This is a single-arm, open, multi-center phase 2 study aimed at evaluating the efficacy and safety of 609A combined with doxorubicin hydrochloride in patients with metastatic/unresectable non-specified soft tissue sarcoma. This study is divided into the first part (safety introduction period) and the second part (phase II).

Part 1: Security lead-in period The safety lead-in period adopts a single-arm, open design to evaluate the safety, tolerability and preliminary effectiveness of 609A combined with doxorubicin hydrochloride. Which aimed to explore the Recommended phase II dose (RP2D).

Part 2: Phase 2 This part adopts a single-arm, open, Simon two-stage design to further evaluate the anti-tumor efficacy and safety of 609A combined with doxorubicin hydrochloride.

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

A Single Arm，Open Label，Multi-centers，Phase 2 Study, Aimed to Evaluate the Efficacy and Safety 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

RP2D of the combination 609A and doxorubicin hydrochloride.

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

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.

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

the Cmax of 609A in patients with long-term medication.

the AUC of 609A in patients with long-term medication.

The Kaplan-Meier method will be used to estimate median PFS.

Duration of response is the mean time to progression for all subjects who responded.

The Kaplan-Meier method will be used to estimate median OS.

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation Level cohort 1. Dose 1 mg/kg, Q3W, IV. Subjects 3-6； Dose Escalation Level cohort 2. Dose 3 mg/kg, Q3W, IV. Subjects 3-6； Dose Escalation Level cohort 3. Dose 200mg, Q3W, IV. Subjects 3-6； Dose Escalation Level cohort 4. Dose 10 mg/kg, Q3W, IV. Subjects 3-6. If 10mg/kg cannot be tolerated, add a dose level of 400mg to assess the tolerance

609A is a recombinant anti-PD-1 humanized IgG4 kappa antibody that targets the human PD-1

Gang Tong

Jie Wang

Shuhang Wang

Phase 1, First in Human, Open-Label, Dose-Escalation Study of 609A in the Patients with Locally advanced/Metastatic Solid Tumors in China.

This is a first-in-human (FIH), open-label, phase 1 dose-escalation study of 609A in China, a recombinant monoclonal anti-PD-1 antibody product, in subjects with Locally advanced/Metastatic Solid Tumors, who must have failed standard treatment (disease progression or intolerance) or lack of standard treatment. If there is a driver gene variant, the subjects must have failed the standard treatment for the driver gene, and there is no other standard treatment.

Phase 1, First in Human, Open-Label, Dose-Escalation Study of 609A in China

A First-in-Human, Open-label, Phase 1 Dose-Escalation Study of 609A in Subjects With Locally Advanced/Metastatic Solid Tumors in China

To access adverse events (AEs) per the NCI CTCAE 5.0.

Maximum Tolerated Dose， if any, and RP2D (s) for 609A will be determined.

the rate of completely response \[CR\] and partial response \[PR\] patients

disease control rates of the patients with 609A

Duration of response of the patients with 609A

Progression-free survival of the patients with 609A

overall survival of the patients with 609A

to detect the presence of anti-609A antibody

Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation Level cohort 1. Dose 1 mg/kg, Q3W, IV. Subjects 3-6; Dose Escalation Level cohort 2. Dose 3 mg/kg, Q3W, IV. Subjects 3-6; Dose Escalation Level cohort 3. Dose 200mg, Q3W, IV. Subjects 3-6; Dose Escalation Level cohort 4. Dose 10 mg/kg, Q3W, IV. Subjects 3-6;

Anthony Tolcher, MD

Aracely Cavazos, BBA

Phase 1, First in Human, Open-Label, Dose-Escalation Study of 609A in the Patients with Locally advanced/Metastatic Solid Tumors

This is a first-in-human (FIH), open-label, phase 1 dose-escalation study of 609A, a recombinant monoclonal anti-PD-1 antibody product, in subjects with Locally advanced/Metastatic Solid Tumors, who must have received, or be intolerant to all available approved or standard therapies known to confirm clinical benefit, or for whom no standard therapy exits.

Phase 1, First in Human, Open-Label, Dose-Escalation Study of 609A

A First-in-Human, Open-label, Phase 1 Dose-Escalation Study of 609A in Subjects With Locally Advanced / Metastatic Solid Tumors

To monitor adverse events (AEs) per the NCI CTCAE 5.0.

Maximum Tolerated Dose, if any, and RP2D (s) for 609A will be determined.

the presence of anti-609A antibody will be assessed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	Sarcoma, Soft T...	609A doxorubicin hyd...	18 Years -	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Phase 1, First in Human, Open-Label, Dose-Escalation Study of 609A in China	NCT03998345	Solid Tumors	609A	18 Years - 70 Years	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Phase 1, First in Human, Open-Label, Dose-Escalation Study of 609A	NCT03950297	Solid Tumors	609A	18 Years -	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
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	Sarcoma, Soft T...	609A doxorubicin hyd...	18 Years -	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Spots Global Cancer Trial Database for 609a

Every month we try and update this database with for 609a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for 609a

Every month we try and update this database with for 609a cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 609a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.