JYB1907 in Subjects With Advanced Solid Tumors

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: JYB1907

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Guorui Wang; Phone Number: +86 18115772113; Email: wangguorui@jemincare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able to provide written informed consent voluntarily;
2. Age ≥18, male or female;
3. Have at least one evaluable lesion (Dose escalation) or measurable lesion;
4. Expected survival ≥12 weeks；
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;

Exclusion Criteria:

1. 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.
2. With severe tumor complications.
3. Pregnant or lactating women, or positive serum pregnancy test;
4. Concurrent participation in another interventional study；
5. With other diseases or clinical abnormalities assessed by the Investigator as ineligible.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JYB1907 Dose 1; 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; Other Names: TGF-β inhibitor
Experimental: JYB1907 Dose 2; 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; Other Names: TGF-β inhibitor
Experimental: JYB1907 Dose 3; 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; Other Names: TGF-β inhibitor
Experimental: JYB1907 Dose 4; 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; Other Names: TGF-β inhibitor
Experimental: JYB1907 Dose 5; 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; Other Names: TGF-β inhibitor

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jemincare
• Investigators: Principal Investigator: Ning Li, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2023
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 24, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: JY190701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The study has been completed at all study sites for at least 2 years
• IPD Sharing Access Criteria: The results of the study in their entirety have been publicly disclosed by or with the consent of the sponsor in an abstract, manuscript, or presentation form; or; The study has been completed at all study sites for at least 2 years;; No such communication, presentation, or publication will include the sponsor's confidential information;; Each investigator agrees to submit all manuscripts or congress abstracts and posters/presentations to the sponsor at least 30 days prior to submission. This allows the sponsor to protect confidential information, provide comments based on information from other studies that may not yet be available to the investigator, and ensure scientific and clinical accuracy.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No