Condition or disease | Intervention/treatment | Phase |
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Solid Tumors | Drug: 609A | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A First-in-Human, Open-label, Phase 1 Dose-Escalation Study of 609A in Subjects With Locally Advanced/Metastatic Solid Tumors in China |
Actual Study Start Date : | July 25, 2020 |
Estimated Primary Completion Date : | December 24, 2020 |
Estimated Study Completion Date : | December 30, 2020 |
Arm | Intervention/treatment |
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Experimental: 609A group
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
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Drug: 609A
609A is a recombinant anti-PD-1 humanized IgG4 kappa antibody that targets the human PD-1
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must meet all the following inclusion criteria to be eligible for participation in this study:
Must have adequate organ function, prior to start of 609A, including the following:
Exclusion Criteria:
Subjects who meet any of the following criteria will not be enrolled:
Regarding previous anti-tumor therapy:
Subjects with acute myocardial infarction, unstable angina pectoris, stroke, or transient ischemic attack occurred within 6 months prior to admission. Subjects with congestive heart failure rated as grade 2 or above (including grade 2) by the New York college of cardiology (NYHA) ,LVEF<50%.And subjects with the following heart diseases:
Contact: Gang Tong | +86- 21- 021-50793963 | tonggang@3sbio.com |
China, Beijing | |
Cancer hospital Chinese academy of medical sceience | Recruiting |
Beijing, Beijing, China, 100021 | |
Principal Investigator: Jie Wang | |
Sub-Investigator: Shuhang Wang |
Tracking Information | |||||
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First Submitted Date ICMJE | June 24, 2019 | ||||
First Posted Date ICMJE | June 26, 2019 | ||||
Last Update Posted Date | September 9, 2020 | ||||
Actual Study Start Date ICMJE | July 25, 2020 | ||||
Estimated Primary Completion Date | December 24, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Phase 1, First in Human, Open-Label, Dose-Escalation Study of 609A in China | ||||
Official Title ICMJE | A First-in-Human, Open-label, Phase 1 Dose-Escalation Study of 609A in Subjects With Locally Advanced/Metastatic Solid Tumors in China | ||||
Brief Summary | Phase 1, First in Human, Open-Label, Dose-Escalation Study of 609A in the Patients with Locally advanced/Metastatic Solid Tumors in China. | ||||
Detailed Description | 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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Solid Tumors | ||||
Intervention ICMJE | Drug: 609A
609A is a recombinant anti-PD-1 humanized IgG4 kappa antibody that targets the human PD-1
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Study Arms ICMJE | Experimental: 609A group
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
Intervention: Drug: 609A
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
24 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 30, 2020 | ||||
Estimated Primary Completion Date | December 24, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Subjects must meet all the following inclusion criteria to be eligible for participation in this study:
Exclusion Criteria: Subjects who meet any of the following criteria will not be enrolled:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03998345 | ||||
Other Study ID Numbers ICMJE | SSGJ-609-UND-I-01 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | ||||
Study Sponsor ICMJE | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | ||||
Verification Date | September 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |