Advanced Solid TumorsPhase 1/2NCT06925581
A Trial of HRS-6768 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing HRS-6768 in people with Advanced Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- HRS-6768
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesChina
- Study dates
- 24 Apr 2025to Apr 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Gaobo Hospital
Beijing, Beijing Municipality, 102206
Lin Shen
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xianjun Yu
Shaoli Song
About this study
Official title: 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- HRS-6768
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-6768Drug
HRS-6768
| Study group | Role | What they receive |
|---|---|---|
| HRS-6768 | Experimental | Not described Receives: Drug: HRS-6768 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1:Dose-limiting toxicity (DLTs)
To evaluate the safety and tolerability of HRS-6768 and determine the RP2D.
Measured: 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.
Measured: 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
Measured: From first dose of study drug to end of treatment (up to approximately 2 years)
Phase 2: Progression-free survival (PFS)
Measured: 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
To measure the radiation dosimetry of HRS-6768
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: From first dose of study drug until disease progression or end of treatment (up to approximately 1 years)
Phase 1/2: Duration of Response (DoR)
Measured: 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.
Measured: From first dose of study drug until disease progression or end of treatment (up to approximately 2 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.
Measured: 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.
Measured: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start24 Apr 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925581
- Sponsor's protocol ID
- HRS-6768-101
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06925581
- Acronym / sponsor ID
- HRS-6768-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-6768 | Experimental | Drug: HRS-6768 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-6768HRS-6768 | Drug | HRS-6768 |
Primary outcome
Phase 1:Dose-limiting toxicity (DLTs)
Time frame: 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)
Time frame: 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 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of HRS-6768
Time frame: 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
Phase 2: Progression-free survival (PFS)
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
10 secondary outcomes
Phase 1/2: Absorbed dose (Gy) estimated in organs and tumor lesions
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 1 years)
Phase 1/2: Duration of Response (DoR)
Time frame: 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)
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1: Progression-free survival (PFS)
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Phase 1/2: Overall Survival (OS)
Time frame: From first dose of study drug until disease progression or end of treatment (up to approximately 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HRS-6768 in people with Advanced Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zengquan Gu (0518-82342973, zengquan.gu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1:Dose-limiting toxicity (DLTs) (time frame: From first dose of study drug through at least 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.