Advanced/Metastatic Solid TumorsPhase 1/2NCT06922357
A Phase I/II of HRS-6719 in Patients With Advanced/Metastatic Solid Tumors
A Phase 1/2 study testing HRS-6719 in people with Advanced/Metastatic Solid Tumors, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.
Trial summary
This is a Phase I/II, multicenter, open-label clinical trial with dose escalation/dose expansion/efficacy expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HRS-6719 in patients with MTAP-deficient advanced solid… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced/Metastatic Solid Tumors
- What is being tested?
- HRS-6719
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 24 Apr 2025to Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must voluntarily participate in the study and sign an informed consent form;
- Aged 18-75 years, male or female eligible；
- ECOG performance status score of 0-1；
- Expected survival ≥12 weeks；
- Patients with histologically or cytologically confirmed advanced malignant solid tumors who meet one of the following criteria:Disease progression or intolerance after receiving adequate standard therapy; Lack of standard treatment options;Currently ineligible for standard therapy；
- Ability to provide sufficient fresh or archived tumor tissue specimens；
- Adequate function of vital organs；
- Effective contraception must be used during the trial. For women of childbearing potential, a negative pregnancy test within 7 days prior to the first dose is required。
Who cannot join
- History of other malignant tumors within the past 5 years；
- Received systemic anti-tumor therapy within 4 weeks prior to the first study dose.
- Surgical procedures requiring tracheal intubation and general anesthesia were performed within 4 weeks before the first administration, diagnostic or surface surgery was performed within 1 week before the first administration, or elective surgery was expected during the trial.
- The study received radical radiotherapy within 4 weeks before the first medication ; and received palliative radiotherapy within 2 weeks before the first medication.
- Uncontrolled pleural, pericardial, or peritoneal effusions.
- Severe cardiac diseases occurring within 6 months prior to the first dose.
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- Arterial/venous thrombosis within 6 months before the first dose.
- Clinically significant bleeding symptoms or predisposition within 3 months prior to the first dose.
- Active infection or fever of unknown origin > 38.5 ° C was present within 4 weeks before the first administration of the study
- History of immunodeficiency.
- Active hepatitis B or C.
- Diseases affecting drug absorption/transport (e.g., malabsorption syndromes).
- A history of severe allergic reactions to HRS-6719 and its main components was known or suspected, or there was a history of delayed allergic reactions, eczema or asthma that could not be controlled by topical corticosteroids.
- Use of strong CYP3A4/P-gp inhibitors/inducers within 5 half-lives before the first dose.
- Adverse events (AEs) from prior anti-tumor therapy not resolved to CTCAE v5.0 ≤ Grade 1.
- Patients with interstitial pneumonia or interstitial lung disease, or previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or clinically significant pulmonary fibrosis, persistent pneumonia, pneumonia caused by drug or radiotherapy, congenital pneumonia, or chest CT scan found any evidence of active pneumonia.
- Through medical history or CT examination, it was found that there was active pulmonary tuberculosis infection within 1 year before enrollment, or more than 1 year ago, there was a history of active pulmonary tuberculosis infection but no formal treatment.
- Live attenuated vaccines administered within 4 weeks before the first dose or planned during the study.
- Other factors potentially compromising study safety or data integrity.
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
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Zhengbo Song
- Recruiting
Barbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Yan Yu
About this study
Official title: A Phase I/II, Open-label, Multi-centre Study Evaluating the Safety,Tolerability,Pharmacokinetic (PK), Pharmacodynamics, and Preliminary Efficacy of HRS-6719 in Patients With Advanced/Metastatic Solid Tumors With MTAP Deficiency
This is a Phase I/II, multicenter, open-label clinical trial with dose escalation/dose expansion/efficacy expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HRS-6719 in patients with MTAP-deficient advanced solid tumors.
- Conditions
- Advanced/Metastatic Solid Tumors
- Being tested
- HRS-6719
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-6719Drug
HRS-6719
| Study group | Role | What they receive |
|---|---|---|
| HRS-6719 | Experimental | Not described Receives: Drug: HRS-6719 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicity (DLT)
Measured: 21 Days (first cycle)
Maximum tolerable dose (MTD)
Measured: 21 Days (first cycle)
Recommended dose for phase II (RP2D)
Measured: through phase I completion, an average of 1 years
Incidence and severity of AE
Measured: from Day1 to 30 days after last dose
Secondary outcomes (7)
Relative bioavailability after meals on an empty stomach
Measured: through phase I completion, an average of 1 years
ORR
Measured: 12 months after the last subject was enrolled in the group
DOR
Measured: 12 months after the last subject was enrolled in the group
DCR
Measured: 12 months after the last subject was enrolled in the group
TTR
Measured: 12 months after the last subject was enrolled in the group
PFS
Measured: 12 months after the last subject was enrolled in the group
OS
Measured: 1 Year after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start24 Apr 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/Metastatic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT06922357
- Sponsor's protocol ID
- HRS-6719-101
- Status last verified
- May 2026
- First submitted
- 3 Apr 2025
- Last updated
- 28 May 2026
- 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label, Multi-centre Study Evaluating the Safety,Tolerability,Pharmacokinetic (PK), Pharmacodynamics, and Preliminary Efficacy of HRS-6719 in Patients With Advanced/Metastatic Solid Tumors With MTAP Deficiency
- ClinicalTrials.gov ID
- NCT06922357
- Acronym / sponsor ID
- HRS-6719-101
- Conditions
- Advanced/Metastatic Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 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.
This is a Phase I/II, multicenter, open-label clinical trial with dose escalation/dose expansion/efficacy expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HRS-6719 in patients with MTAP-deficient 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-6719 | Experimental | Drug: HRS-6719 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must voluntarily participate in the study and sign an informed consent form;
- Aged 18-75 years, male or female eligible；
- ECOG performance status score of 0-1；
- Expected survival ≥12 weeks；
- Patients with histologically or cytologically confirmed advanced malignant solid tumors who meet one of the following criteria:Disease progression or intolerance after receiving adequate standard therapy; Lack of standard treatment options;Currently ineligible for standard therapy；
Key exclusion criteria (19 listed)
- History of other malignant tumors within the past 5 years；
- Received systemic anti-tumor therapy within 4 weeks prior to the first study dose.
- Surgical procedures requiring tracheal intubation and general anesthesia were performed within 4 weeks before the first administration, diagnostic or surface surgery was performed within 1 week before the first administration, or elective surgery was expected during the trial.
- The study received radical radiotherapy within 4 weeks before the first medication ; and received palliative radiotherapy within 2 weeks before the first medication.
- Uncontrolled pleural, pericardial, or peritoneal effusions.
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-6719HRS-6719 | Drug | HRS-6719 |
Primary outcome
Dose Limited Toxicity (DLT)
Time frame: 21 Days (first cycle)
Maximum tolerable dose (MTD)
Time frame: 21 Days (first cycle)
Recommended dose for phase II (RP2D)
Time frame: through phase I completion, an average of 1 years
Incidence and severity of AE
Time frame: from Day1 to 30 days after last dose
7 secondary outcomes
Relative bioavailability after meals on an empty stomach
Time frame: through phase I completion, an average of 1 years
ORR
Time frame: 12 months after the last subject was enrolled in the group
DOR
Time frame: 12 months after the last subject was enrolled in the group
DCR
Time frame: 12 months after the last subject was enrolled in the group
TTR
Time frame: 12 months after the last subject was enrolled in the group
PFS
Time frame: 12 months after the last subject was enrolled in the group
OS
Time frame: 1 Year after last dose
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 28 May 2026.
- 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-6719 in people with Advanced/Metastatic 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 8 inclusion and 19 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 28 May 2026. 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 Shi Wei SUN (18036618554, Shiwei.sun@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limited Toxicity (DLT) (time frame: 21 Days (first cycle)). 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 28 May 2026.