A Trial of HRS-6768 in Patients With Advanced Solid Tumors

A Phase I/II Clinical Trial to Evaluate the Pharmacokinetics, Radiation Dosimetry, Safety and Preliminary Efficacy of HRS-6768 in the Treatment of Patients With Advanced Solid Tumors

The study is being conducted to evaluate the pharmacokinetics, radiation dosimetry, safety and preliminary efficacy of HRS-6768. To explore the reasonable dosage of HRS-6768 in the treatment of patients with advanced solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: HRS-6768

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Zengquan Gu; Phone Number: 0518-82342973; Email: zengquan.gu@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 102206
      • Recruiting
      • Beijing Gaobo Hospital
      • Principal Investigator: Lin Shen
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Principal Investigator: Xianjun Yu
      • Principal Investigator: Shaoli Song

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. subjects with solid tumors who have been histologically or cytologically diagnosed with advanced - stage (unresectable or metastatic) disease, have failed standard treatment (disease progression or intolerance), or lack effective treatment methods.
3. There must be at least one evaluable lesion .
4. ECOG 0-1
5. The functions of major organs are in good condition.

Exclusion Criteria:

1. The patient has experienced significant weight loss within 28 days prior to signing the informed consent form.
2. The patient has previously received radiopharmaceutical therapy or radioactive embolization, or has previously undergone any external beam radiotherapy (EBRT) involving more than 25% of the bone marrow, or has previously had EBRT directly applied to the kidneys, or has received any EBRT within 2 weeks before the first dose.
3. The patient has received anti - tumor treatments such as surgery (excluding diagnostic biopsy and serous cavity effusion drainage), checkpoint inhibitor therapy, other antibody therapies, chemotherapy, targeted therapy, gene therapy, and vaccine therapy within 4 weeks before the first dose.
4. The patient has had a severe infection (CTCAE > Grade 2) within 4 weeks before the first dose, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications. The patient has had symptoms and signs of infection within 2 weeks before the first dose that require intravenous antibiotic treatment (excluding cases of prophylactic antibiotic use).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-6768	Drug: HRS-6768; HRS-6768

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1:Dose-limiting toxicity (DLTs)	To evaluate the safety and tolerability of HRS-6768 and determine the RP2D.	From first dose of study drug through at least 6 weeks
Phase 1: recommended Phase 2 dose (RP2D)	To evaluate the safety and tolerability of HRS-6768 and determine the RP2D.	From first dose of study drug to end of phase 1 treatment (up to approximately 1 years)
Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of HRS-6768	Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of HRS-6768	From first dose of study drug to end of treatment (up to approximately 2 years)
Phase 2: Progression-free survival (PFS)		From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1/2: Absorbed dose (Gy) estimated in organs and tumor lesions	To measure the radiation dosimetry of HRS-6768	From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: Cmax of HRS-6768	To evaluate the PK of HRS-6768	From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: Tmax of HRS-6768	To evaluate the PK of HRS-6768	From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: Area under the curve (AUC) of HRS-6768	To evaluate the PK of HRS-6768	From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: clearance (CL) of HRS-6768	To evaluate the PK of HRS-6768	From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: Duration of Response (DoR)		From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: Disease Control Rate (DCR)	Disease Control Rate (DCR) is defined as the frequency and percentage of participants with stable disease (SD) or CR or PR.	From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: Overall Survival (OS)	Overall Survival (OS) is defined as the time from the date of first dose to the date of death due to any cause.	From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: Objective Response Rate (ORR)	Objective response is defined as a best confirmed response of CR or PR by RECIST v1.1 as assessed by the investigator.	From first dose of study drug until disease progression or end of treatment (up to approximately 1 years)
Phase 1: Progression-free survival (PFS)	Progression-free survival (PFS) is defined as the time from the date of first dose to the date of first evidence of radiographic progression or death due to any cause, whichever occurred first.	From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HRS-6768-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No