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

NCT06925581 | Recruiting Phase 1

• 1 other identifier: HRS-6768-101
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

HRS-6768

EXPERIMENTAL

Drug: HRS-6768

Interventions

HRS-6768 DRUG

HRS-6768

HRS-6768

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent
• 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.
• There must be at least one evaluable lesion .
• ECOG 0-1
• The functions of major organs are in good condition.

You may not qualify if:

• The patient has experienced significant weight loss within 28 days prior to signing the informed consent form.
• 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.
• 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.
• 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).

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Beijing Gaobo Hospital

Beijing, Beijing Municipality, 102206, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Zengquan Gu

CONTACT

0518-82342973; zengquan.gu@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: April 7, 2025
• First Posted: April 13, 2025
• Study Start: April 24, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-04

Locations

CN (2)