A Phase 1 interventional study of JYB1907 in Solid Tumor, sponsored by Jemincare. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by Jemincare · Phase 1, Interventional, and Treatment
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.
9,371 studies on the registry are indexed under Neoplasms; 2,492 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 7,258 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Jemincare is the lead sponsor of 36 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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
for injection
Also known as: TGF-β inhibitor
Adverse events
Adverse events, and changes from baseline in vital signs,etc.
Time frame: until either 28 days after last dose of study drug or initiation of new anticancer therapy, whichever occurs first.
Serum concentrations of JYB1907
JYB1907 assessed by pre-specified methods, and related pharmacokinetic parameters analysis
Time frame: 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
Time frame: 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
Time frame: until 28 days after last dose of study drug
No study locations are listed for this record.
Plan to share: Yes — 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.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Jemincare