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Advanced Solid TumorsPhase 1NCT05781048

A Phase I Clinical Study of the Safety， Tolerability，Pharmacokinetics, and Initial Efficacy of HRS-6209 Monotherapy in Patients With Advanced Solid Tumors

A Phase 1 study testing HRS-6209 in people with Advanced Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The study is being conducted to evaluate the efficacy, andsafety of HRS-6209in subjects with advanced solid tumors.To explore the reasonable dosage of HRS-6209.This study also preliminarily evaluated the efficacy of HRS-6209 in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
HRS-6209
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteChina
Study dates
23 Mar 2023to 30 Dec 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be willing to participate in the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.
  • Aged 18-80 years, male or female
  • Patients with advanced malignant tumors confirmed pathologically;
  • Failure of adequate standard treatment, or no effective standard treatment;
  • Patients must have at least 1 extracranial measurable target lesion per RECIST v1.1 ;
  • The expected survival period is more than 12 weeks;
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  • The Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0 - 1;
  • Have sufficient bone marrow and organ function (have not received blood transfusion or hematopoietic stimulating factor treatment within 14 days)；
  • Female subjects of childbearing age must undergo a serum pregnancy test within 3 days before starting the study medication, and the result is negative, and are willing to use a medically approved high-efficiency contraception during the study period and within 6 months after the last administration of the study drug Measures: For male subjects whose partners are females of childbearing age, they should be surgically sterilized, or agree to use effective methods of contraception during the study period and within 3 months after the last study administration;

Who cannot join

  • Subjects with a history of malignant tumors, except patients with cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma or cervical carcinoma in situ who have undergone possible curative treatment and did not have disease recurrence within 3 years since starting the treatment；
  • Subjects had cancerous meningitis or untreated central nervous system metastases
  • Subjects experienced intestinal obstruction and gastrointestinal perforation within 3 months prior to initial medication
  • There is third-space effusion that cannot be controlled by drainage and other methods (such as massive ascites, pleural effusion, pericardial effusion)；
  • Subjects had clinical cardiac symptoms or disease that was not well controlled within 6 months prior to initial medication
  • Subjects had or currently had idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia , drug pneumonia, or CT during screening showed active pneumonia；
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  • Arteriovenous thrombosis occurred within 6 months prior to the first dose
  • Severe infection occurred within 4 weeks prior to initial administration
  • During the screening period/before the first administration, fever of unknown origin> 38.5°C
  • Known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS)
  • Subjects had active hepatitis；
  • Subjects received live attenuated vaccine within 4 weeks or planned for the study period prior to initial administration；
  • Subjects were scheduled to receive other systemic antitumor therapies during the study period；
  • Participated in other clinical studies within 4 weeks before starting the study drug treatment；
  • Subjects were unable to swallow pills or capsules normally, or had gastrointestinal abnormalities that the researchers determined might affect drug absorption；
  • Other factors as judged by the investigator that may lead to the termination of the study, such as other serious diseases, serious laboratory test abnormalities, or family or social factors that could affect the safety of the subject, or the collection of study data and samples.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center-

    Shanghai, Shanghai Municipality, 201321

Other trials in China

About this study

Official title: An Open-label, Multi-center Phase I Study of Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HRS-6209 Monotherapy in Patients With Advanced Solid Tumors

The study is being conducted to evaluate the efficacy, andsafety of HRS-6209in subjects with advanced solid tumors.To explore the reasonable dosage of HRS-6209.This study also preliminarily evaluated the efficacy of HRS-6209 in patients with advanced solid tumors.

Being tested
HRS-6209

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HRS-6209Drug

    HRS-6209

Study groups in NCT05781048
Study groupRoleWhat they receive
HRS-6209ExperimentalNot described
Receives: Drug: HRS-6209

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety endpoints: Number of subjects with adverse events and the severity of adverse events

    Measured: every 4 weeks after treatment initiation，up to approximately 2 years.

  2. DLT(Dose-limiting toxicity）

    Measured: during the first 30-day cycle of SHR-6209 treatment

  3. MTD（Maximum tolerated dose）

    Measured: 4 weeks after treatment initiation

  4. RP2D（Recommended Phase II Dose）

    Measured: 4 weeks after treatment initiation

Secondary outcomes (4)

  1. ORR（Objective response rate (ORR) - RECIST 1.1

    ORR is defined as the proportion of subjects who have achieved complete response (CR) or partial response (PR) according to RECIST 1.1）

    Measured: Up to approximately 6 months

  2. DoR（Duration of Response (DoR)Duration of Response (DoR) per RECIST 1.1）

    Measured: Up to approximately 2 years

  3. DCR（Disease control rate（DCR）-RECIST 1.1

    DCR is defined as the proportion of subjects who have achieved Stable disease(SD)、complete response (CR) or partial response (PR) according to RECIST 1.1）

    Measured: Up to approximately 2 years

  4. PFS-Progression-free survival(PFS) PFS per RECIST 1.1

    Measured: 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.

  1. First posted23 Mar 2023
  2. Study start23 Mar 2023
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05781048
Sponsor's protocol ID
HRS-6209-I-101
Status last verified
Mar 2026
First submitted
23 Feb 2023
Last updated
10 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HRS-6209 in people with Advanced Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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 9 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety endpoints: Number of subjects with adverse events and the severity of adverse events (time frame: every 4 weeks after treatment initiation，up to approximately 2 years.). 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?

On the ClinicalTrials.gov record for NCT05781048.

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 10 Mar 2026.

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