Solid TumorsPhase 2NCT07032077
A Clinical Trial of HRS-7058 Combined Anti-tumor Drugs in Subjects With Solid Tumors
A Phase 2 study testing HRS-7058 in people with Solid Tumors, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the safety and tolerability of HRS-7058 combined with antitumor drugs in subjects with solid tumors, and to determine the recommended dosage for Phase II. Evaluate the objective response rate of HRS-7058 in combination with anti-tumor drugs in subjects with 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-7058
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2025to Jul 2027
- Phase
- Phase 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
- Patients who are capable of giving informed consent, have signed the informed consent form approved by the IRB/EC and noted the date, and are willing and able to comply with the treatment plan, visits, various examinations, and other procedural requirements.
- Age must be between 18 and 75 years old (inclusive) when signing the informed consent form, gender is unrestricted.
- ECOG score of 0 or 1.
- Expected survival period ≥ 12 weeks.
- Provide 5-15 pieces of tumor tissue blocks fixed in formalin and embedded in paraffin, or unstained tumor specimen slices. The samples should be archived within the first 3 years before treatment or freshly obtained (freshly obtained is preferred). Slices do not need to be provided during the dose escalation phase.
- According to the RECIST v1.1 standard, there must be at least one measurable lesion.
- The functions of important organs meet the standards (no blood components or cell growth factors were used for corrective treatment within 14 days prior to the first administration of the drug), and the examination results must be completed within 7 days before the first study treatment.
- Female subjects of childbearing potential must undergo a serum pregnancy test within 7 days prior to the first dose, and the result must be negative (if the serum HCG test is positive, pregnancy causes must be ruled out and further discussion with the sponsor is required); and must not be breastfeeding. Female subjects of childbearing potential and male partners of female subjects of childbearing potential must agree to follow contraceptive requirements from the time of signing the informed consent until 5 months after the last administration of the study drug (for male subjects) or 8 months (for female subjects) (see "Methods of Contraception" in the study protocol attachments for details).
Who cannot join
- Subjects with untreated or active CNS metastases, a history of meningeal metastasis, or current meningeal metastasis are not eligible for enrollment.
- Start the study if the patient has received systemic anti-tumor treatment within 28 days prior to enrollment. If the patient has previously received small molecule targeted therapy, there must be an interval of at least 5 half-lives of that drug or 14 days, whichever is shorter, between the end of treatment and the first study treatment. If the patient has previously received traditional Chinese medicine or Chinese patent medicine for anti-tumor treatment, they may be enrolled if there is an interval of at least 14 days between the end of treatment and the first study treatment.
- Palliative radiotherapy completed within 14 days before the first administration.
- Unable to recover from the toxicity and/or complications of prior interventions to CTCAE ≤ Grade 1 (excluding conditions such as alopecia, Grade 2 peripheral neuropathy, and other situations deemed by the investigator not to affect the treatment with the investigational drug that meet the numerical requirements in the enrollment criteria).
- Used strong CYP3A4 inhibitors and P-gp, BCRP inhibitors within 7 days prior to the first administration, or used strong CYP3A4 inducers within 14 days prior to the first administration.
- Subjects with known or suspected interstitial pneumonia; those with significant pulmonary diseases impacting respiratory function in the three months prior to the first administration, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/obliterative bronchiolitis, pulmonary embolism, severe asthma, severe COPD, moderate to severe obstructive/restrictive ventilatory dysfunction, or those with a history of undergoing total lung resection. Subjects who previously had grade 3 or higher interstitial pneumonia during treatment with immune checkpoint inhibitors are not allowed to enroll in this study.
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- Patients with serious cardiovascular and cerebrovascular diseases.
- Patients with a history of or concurrent other malignant tumors, unless they have achieved complete remission for at least 5 years prior to screening and do not require other treatment for basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, local prostate cancer after radical surgery, or ductal carcinoma in situ after radical surgery during the study period (hormonal treatment for non-metastatic prostate cancer or breast cancer is allowed).
- Subjects who experienced severe infections within 28 days prior to the first dose of medication, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.; active infections treated with therapeutic intravenous antibiotics within 2 weeks prior to the start of study treatment.
- Those with active pulmonary tuberculosis infection within 1 year before enrollment, or those with a history of active pulmonary tuberculosis infection over 1 year ago but have not received formal treatment.
- Presence of active hepatitis B (HBV DNA above the normal upper limit of the research center or ≥ 2000 IU/mL) or hepatitis C (anti-HCV positive and HCV RNA above the lower limit of the analysis method); presence of active syphilis infection.
- Live attenuated vaccine used within 28 days prior to the first administration of the study drug, or expected to use live attenuated vaccine during the anticipated treatment period.
- Patients with a history of immune deficiency diseases, including positive HIV tests, other acquired or congenital immune deficiency diseases, and those with a history of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- Patients with third space fluid accumulation that cannot be controlled clinically, deemed unsuitable for enrollment by the investigator.
- Patients with refractory nausea and vomiting, chronic gastrointestinal diseases, etc., leading to an inability to swallow HRS-7058, or with intestinal obstruction, undergoing intestinal resection, etc., leading to insufficient absorption of HRS-7058.
- Patients who had significant clinically meaningful bleeding symptoms within 3 months before the first study medication, and those who had noticeable hemoptysis within 1 month before the first study medication with each episode of hemoptysis being ≥ 2.5 ml.
- Patients who have undergone other major surgeries excluding diagnosis or biopsy within 28 days prior to the first administration; those who have experienced traumatic minor surgeries (biopsy, endoscopy, and drainage) within 7 days prior to the first administration; patients with non-healing wounds (severe, non-healing or ruptured) or untreated fractures.
- Women who are pregnant or breastfeeding (even if the subject's blood pregnancy test is negative, if the researcher considers the subject's other circumstances and believes there may be a possibility of pregnancy, they need to be excluded; breastfeeding women are also not allowed to stop breastfeeding in order to participate in this study).
- Patients known to be allergic to any component of HRS-7058; patients with a known history of severe allergic reactions to the combined therapeutic antitumor drugs.
- Patients with uncontrollable mental illnesses as well as known situations of alcoholism, drug abuse or misuse, and criminal detention that affect the completion of the research procedures.
- According to the investigators' judgment, patients who may have other conditions that could increase the risk of participating in the study, interfere with the research results, or make them unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, +86-010-88196561, doctorshenlin@sina.cn
Lin Shen
About this study
Official title: A Phase II Clinical Trial on the Safety, Tolerability, and Efficacy of HRS-7058 Combined Anti-tumor Drugs in Subjects With Solid Tumors
This study aims to evaluate the safety and tolerability of HRS-7058 combined with antitumor drugs in subjects with solid tumors, and to determine the recommended dosage for Phase II. Evaluate the objective response rate of HRS-7058 in combination with anti-tumor drugs in subjects with solid tumors.
- Conditions
- Solid Tumors
- Being tested
- HRS-7058
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7058Drug
HRS-7058 combined with antitumor drugs.
| Study group | Role | What they receive |
|---|---|---|
| HRS-7058 | Experimental | HRS-7058 combined with antitumor drugs. Receives: Drug: HRS-7058 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of dose-limiting toxicities (DLT).
Measured: About 28 days.
The incidence and severity of adverse events (AEs).
According to NCI-CTCAE v5.0 standards.
Measured: About 28 days.
Recommended Phase 2 Dose (RP2D) of HRS-7058 in combination with antitumor drugs in subjects with solid tumors.
Measured: From the first dose to the last visit, about 12 months.
Secondary outcomes (8)
The duration of response (DoR) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs.
Measured: From the first dose to the last visit, about 12 months.
The objective response rate (ORR) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs.
Measured: From the first dose to the last visit, about 12 months.
The disease control rate (DCR) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs.
Measured: From the first dose to the last visit, about 12 months.
The progression-free survival (PFS) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs.
Measured: From the first dose to the last visit, about 12 months.
The overall survival (OS) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs.
Measured: From the first dose to the last visit, about 12 months.
The blood concentration of HRS-7058 and SHR-1826.
Measured: From the first dose to the last visit, about 12 months.
Anti-drug antibodies (ADA).
Evaluation of the immunogenicity.
Measured: From the first dose to the last visit, about 12 months.
Neutralizing antibodies (NAb).
Evaluation of the immunogenicity.
Measured: From the first dose to the last visit, about 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start9 Jul 2025
- Primary completionJun 2027 (estimated)
- Study completionJul 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT07032077
- Sponsor's protocol ID
- HRS-7058-201-CRC
- Status last verified
- Mar 2026
- First submitted
- 13 Jun 2025
- Last updated
- 20 Mar 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial on the Safety, Tolerability, and Efficacy of HRS-7058 Combined Anti-tumor Drugs in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT07032077
- Acronym / sponsor ID
- HRS-7058-201-CRC
- Conditions
- Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 22 Jun 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 study aims to evaluate the safety and tolerability of HRS-7058 combined with antitumor drugs in subjects with solid tumors, and to determine the recommended dosage for Phase II. Evaluate the objective response rate of HRS-7058 in combination with anti-tumor drugs in subjects with 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-7058 | Experimental | Drug: HRS-7058HRS-7058 combined with antitumor drugs. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who are capable of giving informed consent, have signed the informed consent form approved by the IRB/EC and noted the date, and are willing and able to comply with the treatment plan, visits, various examinations, and other procedural requirements.
- Age must be between 18 and 75 years old (inclusive) when signing the informed consent form, gender is unrestricted.
- ECOG score of 0 or 1.
- Expected survival period ≥ 12 weeks.
- Provide 5-15 pieces of tumor tissue blocks fixed in formalin and embedded in paraffin, or unstained tumor specimen slices. The samples should be archived within the first 3 years before treatment or freshly obtained (freshly obtained is preferred). Slices do not need to be provided during the dose escalation phase.
Key exclusion criteria (21 listed)
- Subjects with untreated or active CNS metastases, a history of meningeal metastasis, or current meningeal metastasis are not eligible for enrollment.
- Start the study if the patient has received systemic anti-tumor treatment within 28 days prior to enrollment. If the patient has previously received small molecule targeted therapy, there must be an interval of at least 5 half-lives of that drug or 14 days, whichever is shorter, between the end of treatment and the first study treatment. If the patient has previously received traditional Chinese medicine or Chinese patent medicine for anti-tumor treatment, they may be enrolled if there is an interval of at least 14 days between the end of treatment and the first study treatment.
- Palliative radiotherapy completed within 14 days before the first administration.
- Unable to recover from the toxicity and/or complications of prior interventions to CTCAE ≤ Grade 1 (excluding conditions such as alopecia, Grade 2 peripheral neuropathy, and other situations deemed by the investigator not to affect the treatment with the investigational drug that meet the numerical requirements in the enrollment criteria).
- Used strong CYP3A4 inhibitors and P-gp, BCRP inhibitors within 7 days prior to the first administration, or used strong CYP3A4 inducers within 14 days prior to the first administration.
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-7058HRS-7058 combined with antitumor drugs. | Drug | HRS-7058 |
Primary outcome
The incidence of dose-limiting toxicities (DLT).
Time frame: About 28 days.
The incidence and severity of adverse events (AEs).
Time frame: About 28 days.
According to NCI-CTCAE v5.0 standards.
Recommended Phase 2 Dose (RP2D) of HRS-7058 in combination with antitumor drugs in subjects with solid tumors.
Time frame: From the first dose to the last visit, about 12 months.
8 secondary outcomes
The duration of response (DoR) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs.
Time frame: From the first dose to the last visit, about 12 months.
The objective response rate (ORR) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs.
Time frame: From the first dose to the last visit, about 12 months.
The disease control rate (DCR) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs.
Time frame: From the first dose to the last visit, about 12 months.
The progression-free survival (PFS) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs.
Time frame: From the first dose to the last visit, about 12 months.
The overall survival (OS) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs.
Time frame: From the first dose to the last visit, about 12 months.
The blood concentration of HRS-7058 and SHR-1826.
Time frame: From the first dose to the last visit, about 12 months.
Anti-drug antibodies (ADA).
Time frame: From the first dose to the last visit, about 12 months.
Neutralizing antibodies (NAb).
Time frame: From the first dose to the last visit, about 12 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 20 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-7058 in people with Solid Tumors, run by Shandong Suncadia 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 8 inclusion and 21 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 20 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 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 Zhengjin Zhang (+86-0518-82342973, zhengjin.zhang.zz79@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of dose-limiting toxicities (DLT). (time frame: About 28 days.). The study lists 3 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 20 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.