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

NCT06727812 | Recruiting Phase 1

• 1 other identifier: HRS-6208-101
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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 toxicity (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 Outcomes (5)

• 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).

Study Arms (1)

Experimental arm

EXPERIMENTAL

Drug: HRS-6208

Interventions

HRS-6208 DRUG

HRS-6208.

Experimental arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Age 18\~75 years old;
• At least one measurable lesion per RECIST v1.1 criteria;
• ECOG PS score: 0-1.

You may not qualify if:

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

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (2)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Central Study Contacts

Xin Xu

CONTACT

0518-82342973; xin.xu@hengrui.com

Zhiye Chen

CONTACT

0518-82342973; zhiye.chen.zc78@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

CN (2)