Multicenter Phase I Study of HRS-6208 in Patients With Solid Tumors

Shandong Suncadia Medicine

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumors

Treatments: Drug: HRS-6208

Study type: Interventional

Funder types: Industry

Identifiers

NCT06727812

HRS-6208-101

Details and patient eligibility

About

This is an open, multicenter Phase I study to evaluate the safety and tolerability of HRS-6208 in patients with advanced solid tumors.

Enrollment: 206 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with unresectable locally advanced or metastatic solid tumors confirmed by histology or cytology who have relapsed or progressed after standard treatment, or have no standard treatment options, or do not apply standard treatment at this stage;
2. Age 18~75 years old;
3. At least one measurable lesion per RECIST v1.1 criteria;
4. ECOG PS score: 0-1.

Exclusion criteria

1. History of other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
2. The adverse reactions of previous anti-tumor therapy have not recovered to NCI-CTCAE v5.0 grade evaluation ≤ 1;
3. He has severe cardiovascular and cerebrovascular diseases;
4. Severe infection within 4 weeks prior to the first dose.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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206 participants in 1 patient group

Experimental arm

Experimental group

Treatment:

Drug: HRS-6208