JYB1907 in Subjects With Advanced Solid Tumors

NCT05821595 | Unknown Phase 1 FDA Drug

• 1 other identifier: JY190701
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Serum concentrations of JYB1907

  until 28 days after last dose of study drug

• Serum concentrations of Immunogenicity Analysis

  until 28 days after last dose of study drug

• Serum concentrations of Preliminary antitumor activity

  until 28 days after last dose of study drug

Study Arms (5)

JYB1907 Dose 1

EXPERIMENTAL

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

JYB1907 Dose 2

EXPERIMENTAL

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

JYB1907 Dose 3

EXPERIMENTAL

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

JYB1907 Dose 4

EXPERIMENTAL

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

JYB1907 Dose 5

EXPERIMENTAL

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

Interventions

JYB1907 DRUG

for injection

Also known as: TGF-β inhibitor

JYB1907 Dose 1; JYB1907 Dose 2; JYB1907 Dose 3; JYB1907 Dose 4; JYB1907 Dose 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jemincare: lead

Study Officials

• Ning Li

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guorui Wang

CONTACT

+86 18115772113; wangguorui@jemincare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 20, 2023
• Study Start: July 31, 2023
• Primary Completion: September 15, 2024
• Study Completion: October 31, 2024
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study has been completed at all study sites for at least 2 years;
• 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.