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

Phase 1

Recruiting

• Conditions: Solid Tumors
• Interventions: Drug: HRS-6208

• Registration Number: NCT06727812
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-06
• Study First Posted: 2024-12-11
• Study Start: 2024-12-27
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 206

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	HRS-6208	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs)	From Day 1 to 30 days after the last dose.
Maximum tolerated dose (MTD)	From Day 1 to 21 days after the first dose.
Dose limiting toxicitie (DLT)	From Day 1 to 21 days after the first dose.
Recommended phase 2 dose (RP2D)	From Day 1 to 30 days after the last dose.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
Duration of Response (DoR)	From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
Disease Control Rate (DCR)	From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
Progression free Survival (PFS)	From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
Overall Survival (OS)	From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China