JYB1907 in Subjects With Advanced Solid Tumors

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: JYB1907


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide written informed consent voluntarily; Age ≥18, male or female; Have at least one evaluable lesion (Dose escalation) or measurable lesion; Expected survival ≥12 weeks； Eastern Cooperative Oncology Group (ECOG) performance status ≤2; Exclusion Criteria: Received within 4 weeks before the initial treatment, or scheduled during the study to receive a major surgery, live attenuated vaccines, or any anti-tumor therapy. With severe tumor complications. Pregnant or lactating women, or positive serum pregnancy test; Concurrent participation in another interventional study； With other diseases or clinical abnormalities assessed by the Investigator as ineligible.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JYB1907 Dose 1<br>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. | Drug: JYB1907<br>* for injection<br>* Other names: TGF-β inhibitor;|
| Experimental: JYB1907 Dose 2<br>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. | Drug: JYB1907<br>* for injection<br>* Other names: TGF-β inhibitor;|
| Experimental: JYB1907 Dose 3<br>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. | Drug: JYB1907<br>* for injection<br>* Other names: TGF-β inhibitor;|
| Experimental: JYB1907 Dose 4<br>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. | Drug: JYB1907<br>* for injection<br>* Other names: TGF-β inhibitor;|
| Experimental: JYB1907 Dose 5<br>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. | Drug: JYB1907<br>* for injection<br>* Other names: TGF-β inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |