Recruiting NCT06764628
A Study of SHR-4375 in Subjects With Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-4375.
- Who it may be relevant to
- Registry conditions: Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label, Single-arm, Multicenter Phase I/II Clinical Study of SHR-4375 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy
Overview
This is an open-label, three-part study to evaluate the safety and efficacy of SHR-4375 for injection in subjects with solid tumors.
Interventions
- Drug SHR-4375
SHR-4375 injection
Primary outcome measures
- Adverse events (AEs) [Time frame: From Day 1 to 90 days after last dose.]
- Dose limiting toxicity (DLT) [Time frame: From Day 1 to 12 months.]
- Maximal tolerable dose (MTD) [Time frame: From Day 1 to 12 months.]
- Recommended phase 2 dose (RP2D) [Time frame: From Day 1 to 12 months.]
Secondary outcome measures (5)
- Progression free survival (PFS) [Time frame: From Day 1 to 12 months.]
- Objective response rate (ORR) [Time frame: From Day 1 to 12 months.]
- Disease control rate (DCR) [Time frame: From Day 1 to 12 months.]
- Duration of response (DOR) [Time frame: From Day 1 to 12 months.]
- Overall survival (OS) [Time frame: From Day 1 to 12 months.]
Eligibility criteria
Inclusion criteria
- 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.
- Subjects with cytologically or histologically confirmed advanced solid tumors who have failed or are intolerant to standard therapy, have no standard therapy, or refuse standard therapy.
Exclusion criteria
- Symptomatic, untreated or active central nervous system metastases.
- With any active autoimmune disease or history of autoimmune disease.
- Patients with active hepatitis B or hepatitis C.
- Severe infections prior to initiation of study treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06764628 · SHR-4375-101