A Trial of SHR-4602 Infusion in Patients With SHR-4602 in... | NCT06560138

Status Module

Label	Type	Description	Intervention Names
SHR-4602 Dose level 1 : 2.0 mg/kg, Dose level 2 : 2.5mg/kg	Experimental		Drug: SHR-4602

Name	Type	Description	Arm Group Labels	Other Names
SHR-4602	Drug	SHR-4602 will be administered through IV infusion.	SHR-4602 Dose level 1 : 2.0 mg/kg, Dose level 2 : 2.5mg/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the phase II dose (RP2D) of SHR-4602	RP2D is defined as the dose of SHR-4602 recommended for efficacy study in Phase II. It will be the dose with promising clinical responses observed in the subjects, well tolerated by subjects without exceeding a pre-set number of adverse events.	From the time when the subjects sign the informed consent form to 45(±3) days after the last dose of SHR-4602, or the start of new anti-tumor treatment (whichever comes first).assessed for a maximum duration of up to 1 year

Secondary Outcomes

Measure	Description	Time Frame
Cmax	Cmax are the maximum observed plasma concentrations of SHR-4602, total antibodies, and free toxin after the first dose, directly observed from data.	Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year
Tmax

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
ECOG PS score 0 or 1
Life expectancy ≥ 12 weeks
Adequate bone marrow and other vital organ functions
Adequate liver function tests
HER 2 exprission advanced solid tumor

Exclusion Criteria:

Inclusion Criteria

Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
ECOG PS score 0 or 1
Life expectancy ≥ 12 weeks
Adequate bone marrow and other vital organ functions
Adequate liver function tests
HER 2 exprission advanced solid tumor

Exclusion Criteria

Active brain metastases, carcinomatous meningitis/leptomeningeal metastases.
Have received surgery (eg. major surgerical treatment for cancer), chemotherapy, molecular targeted therapy, immunotherapy, cell therapy, or radiotherapy within 4 weeks prior to the first dose of investigational drug (palliative radiotherapy within 2 weeks prior to the first dose).
Participated in another clinical study with the last dose of study drug received in less than 4 weeks prior to the first dose.
Subjects with toxicities and/or complications from prior treatment not recovered to NCI-CTCAE Grade ≤ 1.
History of pleural fluid, ascites, or pericardial effusion requiring intervention within 2 weeks prior to the first dose.
History of active autoimmune diseases.
History of hereditary or acquired bleeding disorders or thrombotic tendency
Active hepatitis B (defined as hepatitis B virus surface antigen [HBsAg] positive and serum HBV-DNA copy ≥ 500 IU/mL), hepatitis C
History of severe infection within the past 30 days, including but not limited to bacteremia, severe sepsis, pneumonia requiring hospitalization
Other malignancies currently or within the past 5 years, except for cured cervical carcinoma in situ
Allergy to any component or excipient of the SHR-4602 product,
History of severe medical, psychiatric, or social conditions deemed by the investigator to be likely to interfere with a subject's ability to understand, consent, cooperate and participate in the study.
Patients with Grade≥2 peripheral neuropathy, except for those with mild symptoms that do not require treatment

Facility	Status	City	State	ZIP	Country	Contacts
Scientia Clinical Research Limited		Randwick	New South Wales	2031	Australia
Macquarie University