JYB1907 in Subjects With Advanced Solid Tumors

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05821595
• Other study ID #: JY190701
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 31, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: June 2023
• Source: Jemincare
• Contact: Guorui Wang
• Phone: +86 18115772113
• Email: wangguorui[@]jemincare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 31, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• JYB1907
for injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jemincare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum concentrations of JYB1907	JYB1907 assessed by pre-specified methods, and related pharmacokinetic parameters analysis	until 28 days after last dose of study drug
Secondary	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
Secondary	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