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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: HRS-6768

• Registration Number: NCT06925581
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-07
• Study First Posted: 2025-04-13
• Study Start: 2025-04-24
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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 measurable lesion as the target lesion (according to the RECIST V1.1 criteria).
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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRS-6768	HRS-6768	-

Primary Outcome Measures

Name	Time	Method
Phase 1:Dose-limiting toxicity (DLTs)	From first dose of study drug through at least 6 weeks	To evaluate the safety and tolerability of HRS-6768 and determine the RP2D.
Phase 1: recommended Phase 2 dose (RP2D)	From first dose of study drug to end of phase 1 treatment (up to approximately 1 years)	To evaluate the safety and tolerability of HRS-6768 and determine the RP2D.
Phase 2: Objective Response Rate (ORR)	From first dose of study drug to end of treatment (up to approximately 2 years)	Objective response is defined as a best confirmed response of CR or PR by RECIST v1.1 as assessed by the investigator.
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 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of HRS-6768

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China