JYB1907 in Subjects With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2024-10-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

JYB1907

Intervention Type DRUG

for injection

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.

Group Type EXPERIMENTAL

JYB1907

Intervention Type DRUG

for injection

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.

Group Type EXPERIMENTAL

JYB1907

Intervention Type DRUG

for injection

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.

Group Type EXPERIMENTAL

JYB1907

Intervention Type DRUG

for injection

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.

Group Type EXPERIMENTAL

JYB1907

Intervention Type DRUG

for injection

Interventions

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JYB1907

for injection

Intervention Type DRUG

Other Intervention Names

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TGF-β inhibitor

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No