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A Clinical Study of SHR-4595 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability and Pharmacokinetics

ConditionSolid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

The study is being conducted to evaluate the safety and tolerability of SHR-4595 for injection in participants with advanced solid tumors, and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended dose for Phase II clinical studies (RP2D) of SHR-4595.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subjects voluntarily joined the study and signed the ICF.

Measurable disease, as defined by RECIST v1.1.

The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.

Life expectancy ≥ 12 weeks.

Disqualifiers

Symptomatic, untreated or active central nervous system metastases.

Have uncontrolled or severe cardiovascular disease Have clinical symptoms or disease of the heart that are not well controlled.

With any active autoimmune disease or history of autoimmune disease.

Patients with active hepatitis B or hepatitis C.

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-4595 for Injection

    Drug

    SHR-4595 for injection, in different doses.

Treatment groups

208 Participants
are divided into 1 treatment group
Group A: SHR-4595 GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events (AEs)

Safety endpoints.

Time frame
From Day 1 to 40 days after last dose.
2

Dose-limiting toxicity (DLT)

Safety endpoints.

Time frame
From Day 1 to 12 months.
3

Maximum Tolerated Dose (MTD)

Safety endpoints.

Time frame
From Day 1 to 12 months.
4

Recommended Phase 2 Dose (RP2D)

Safety endpoints.

Time frame
From Day 1 to 12 months.

Secondary outcomes

1

Progression free survival (PFS)

Time frame
From Day 1 to 12 months.
2

Objective response rate (ORR)

Time frame
From Day 1 to 12 months.
3

Disease control rate (DCR)

Time frame
From Day 1 to 12 months.
4

Duration of response (DOR)

Time frame
From Day 1 to 12 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: