Solid TumorsPhase 1NCT06727812
Multicenter Phase I Study of HRS-6208 in Patients With Solid Tumors
A Phase 1 study testing HRS-6208 in people with Solid Tumors, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.
Trial summary
This is an open, multicenter Phase I study to evaluate the safety and tolerability of HRS-6208 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- HRS-6208
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 2 sitesChina
- Study dates
- 17 Dec 2024to Aug 2027
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Ping Feng, 028-85423583, 617130961@qq.com
Ting Luo, 028-85423583, luoting@wchscu.cn
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Hongqian Guo, +86-025-83106666, gymwpi@126.com
Hongqian Guo
About this study
Official title: A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HRS-6208 Monotherapy in Patients With Advanced Solid Tumors
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
- Being tested
- HRS-6208
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-6208Drug
HRS-6208.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Not described Receives: Drug: HRS-6208 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Measured: From Day 1 to 30 days after the last dose.
Maximum tolerated dose (MTD)
Measured: From Day 1 to 21 days after the first dose.
Dose limiting toxicity (DLT)
Measured: From Day 1 to 21 days after the first dose.
Recommended phase 2 dose (RP2D)
Measured: From Day 1 to 30 days after the last dose.
Secondary outcomes (5)
Objective Response Rate (ORR)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
Overall Survival (OS)
Measured: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start17 Dec 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727812
- Sponsor's protocol ID
- HRS-6208-101
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2024
- Last updated
- 18 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HRS-6208 Monotherapy in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06727812
- Acronym / sponsor ID
- HRS-6208-101
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 11 Dec 2024 (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.
This is an open, multicenter Phase I study to evaluate the safety and tolerability of HRS-6208 in 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 |
|---|---|---|
| Experimental arm | Experimental | Drug: HRS-6208 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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-6208HRS-6208. | Drug | Experimental arm |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: From Day 1 to 30 days after the last dose.
Maximum tolerated dose (MTD)
Time frame: From Day 1 to 21 days after the first dose.
Dose limiting toxicity (DLT)
Time frame: From Day 1 to 21 days after the first dose.
Recommended phase 2 dose (RP2D)
Time frame: From Day 1 to 30 days after the last dose.
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
Overall Survival (OS)
Time frame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
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 18 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 study testing HRS-6208 in people with Solid Tumors, run by Shandong Suncadia 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 4 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 18 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 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.
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 Xin Xu (0518-82342973, xin.xu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: From Day 1 to 30 days after the last dose.). 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 18 Dec 2025.