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A Phase I, Multi-center, Open-label Study with Dose-escalation and Multiple Expansion Cohorts to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JYB1907 in Subjects with Advanced Solid Tumors
Dose escalation This part is meant to evaluate the safety, tolerability, PK, immunogenicity, preliminary antitumor activity, the MTD and RP2D of JYB1907 in patients with histologically or cytologically confirmed advanced solid tumors.
Expansion cohort The antitumor activity, safety, tolerability, PK and immunogenicity of JYB1907 will be further evaluated in other cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JYB1907 Dose 1 | Experimental | Five dose levels of JYB1907 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected. The dose of JYB1907 is based on the actual body weight as measured prior to each intravenous administration. |
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| JYB1907 Dose 2 | Experimental | Five dose levels of JYB1907 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected. The dose of JYB1907 is based on the actual body weight as measured prior to each intravenous administration. |
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| JYB1907 Dose 3 | Experimental | Five dose levels of JYB1907 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected. The dose of JYB1907 is based on the actual body weight as measured prior to each intravenous administration. |
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| JYB1907 Dose 4 | Experimental | Five dose levels of JYB1907 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected. The dose of JYB1907 is based on the actual body weight as measured prior to each intravenous administration. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JYB1907 | Drug | for injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events, and changes from baseline in vital signs,etc. | until either 28 days after last dose of study drug or initiation of new anticancer therapy, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentrations of JYB1907 | JYB1907 assessed by pre-specified methods, and related pharmacokinetic parameters analysis | until 28 days after last dose of study drug |
| Serum concentrations of Immunogenicity Analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guorui Wang | Contact | +86 18115772113 | wangguorui@jemincare.com |
| Name | Affiliation | Role |
|---|---|---|
| Ning Li | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
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The results of this study will be published or presented at scientific meetings in a timely, objective, and clinically meaningful manner that is consistent with good science, industry and regulator guidance, and the need to protect the intellectual property of the sponsor, regardless of the outcome of the trial. The data generated in this clinical trial are the exclusive property of the sponsor and are confidential. For multicenter studies, the first publication or disclosure of study results shall be a complete, joint multicenter publication or disclosure coordinated by the sponsor. Thereafter, any secondary publications will reference the original publication(s). Authorship will be determined by mutual agreement and all authors must meet the criteria for authorship established by the International Committee of Medical Journal Editors.
The study has been completed at all study sites for at least 2 years;
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| JYB1907 Dose 5 | Experimental | Five dose levels of JYB1907 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected. The dose of JYB1907 is based on the actual body weight as measured prior to each intravenous administration. |
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immunogenicity of JYB1907 assessed by pre-specified methods, and related immunogenic features analysis
| until 28 days after last dose of study drug |
| Serum concentrations of Preliminary antitumor activity | To evaluate the preliminary antitumor activity of JYB1907 in patients with advanced solid tumors assessed by Recist1.1 | until 28 days after last dose of study drug |