JYB1907 in Subjects With Advanced Solid Tumors

Jemincare

Status and phase: Not yet enrolling; Phase 1

Conditions: Solid Tumor

Treatments: Drug: JYB1907

Study type: Interventional

Funder types: Industry

Identifiers

NCT05821595

JY190701

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

JYB1907 Dose 1

Experimental group

Description:

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.

Treatment:

Drug: JYB1907

JYB1907 Dose 2

Experimental group

Description:

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.

Treatment:

Drug: JYB1907

JYB1907 Dose 3

Experimental group

Description:

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.

Treatment:

Drug: JYB1907

JYB1907 Dose 4

Experimental group

Description:

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.

Treatment:

Drug: JYB1907

JYB1907 Dose 5

Experimental group

Description:

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.

Treatment:

Drug: JYB1907