JYB1907 in Subjects With Advanced Solid Tumors

Phase 1

Not yet recruiting

• Conditions: Solid Tumor
• Interventions: Drug: JYB1907

• Registration Number: NCT05821595
• Lead Sponsor: Jemincare

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-04-06
• Study First Posted: 2023-04-20
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-24
• Last Update Posted: 2023-06-27
• Study Start: 2023-07-31
• Primary Completion: 2024-09-15
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
JYB1907 Dose 2	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.
JYB1907 Dose 3	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.
JYB1907 Dose 5	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.
JYB1907 Dose 4	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.
JYB1907 Dose 1	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.

Primary Outcome Measures

Name	Time	Method
Adverse events	until either 28 days after last dose of study drug or initiation of new anticancer therapy, whichever occurs first.	Adverse events, and changes from baseline in vital signs,etc.

Secondary Outcome Measures

Name	Time	Method
Serum concentrations of Immunogenicity Analysis	until 28 days after last dose of study drug	immunogenicity of JYB1907 assessed by pre-specified methods, and related immunogenic features analysis
Serum concentrations of JYB1907	until 28 days after last dose of study drug	JYB1907 assessed by pre-specified methods, and related pharmacokinetic parameters analysis
Serum concentrations of Preliminary antitumor activity	until 28 days after last dose of study drug	To evaluate the preliminary antitumor activity of JYB1907 in patients with advanced solid tumors assessed by Recist1.1