Advanced Malignant TumourPhase 1NCT06383871
A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour
A Phase 1 study testing HRS-7058 capsule/ HRS-7058 tablet in people with Advanced Malignant Tumour, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Tumour
- What is being tested?
- HRS-7058 capsule/ HRS-7058 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2024to Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;
- 18 to 75 years old (including both ends), gender is not limited;
- Subjects with locally advanced or metastatic solid tumour confirmed by histopathology;
- Having at least one evaluable or measurable lesion according to the solid tumour response Evaluation Criteria (RECIST 1.1);
- ECOG Performance Status of 0 or 1;
- The expected survival time is more than 3 months;
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- Be able to ingest drugs and be able to comply with trial and follow-up procedures;
- Adequate bone marrow and organ function;
- Fertile women must agree to abstain from sex (abstaining from heterosexual intercourse) or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the last dose of the study drug. The blood HCG test must be negative within 7 days before the start of the study treatment, and must be non-lactating;
- For male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly effective method of contraception.
Who cannot join
- Accompanied by untreated or active central nervous system (CNS) tumour metastasis;
- Had other malignancies within five years prior to first use of the investigational drug;
- With severe cardiovascular and cerebrovascular disease；
- Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications;
- The presence of uncontrolled pleural, abdominal or pericardial effusion;
- Severe infection within 4 weeks prior to initiation of study treatment;
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- History of immune deficiency;
- The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤ grade 1;
- Antitumor therapy such as chemotherapy, biotherapy, targeted therapy, immunotherapy, or other unmarketed investigational drug therapy within 4 weeks prior to initial use of the investigational drug;
- Had undergone major organ surgery within 4 weeks prior to the first use of the study drug;
- Women who are pregnant, breastfeeding, or who plan to become pregnant within one week of their last use of the study drug during the study period;
- Known allergies and contraindications to the investigational drug or any of its components;
- In the investigator's judgment, the subjects had other factors that could have affected the study results or led to the forced termination of the 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
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Dingzhi Huang
About this study
Official title: An Open, Multicenter Phase I Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-7058 Monotherapy in Patients With Advanced Solid Tumour With KRAS G12C Mutation
This study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058.
- Conditions
- Advanced Malignant Tumour
- Being tested
- HRS-7058 capsule/ HRS-7058 tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7058 capsule/ HRS-7058 tabletDrug
HRS-7058 capsule/ HRS-7058 tablet
| Study group | Role | What they receive |
|---|---|---|
| HRS-7058 | Experimental | Not described Receives: Drug: HRS-7058 capsule/ HRS-7058 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Measured: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
maximum tolerated dose (MTD)
Measured: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Phase II recommended dose (RP2D)
Measured: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Safety endpoints: adverse events (AE)
Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 21 months]
Secondary outcomes (5)
Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion
Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion
Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion
Measured: From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion
Measured: From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: overall survival (OS)
Measured: From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start6 Jun 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumourStudies 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
- 233 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
- NCT06383871
- Sponsor's protocol ID
- HRS-7058-101
- Status last verified
- May 2025
- First submitted
- 19 Apr 2024
- Last updated
- 21 Jan 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Phase I Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-7058 Monotherapy in Patients With Advanced Solid Tumour With KRAS G12C Mutation
- ClinicalTrials.gov ID
- NCT06383871
- Acronym / sponsor ID
- HRS-7058-101
- Conditions
- Advanced Malignant Tumour
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 233 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 25 Apr 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 study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058.
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-7058 capsule/ HRS-7058 tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;
- 18 to 75 years old (including both ends), gender is not limited;
- Subjects with locally advanced or metastatic solid tumour confirmed by histopathology;
- Having at least one evaluable or measurable lesion according to the solid tumour response Evaluation Criteria (RECIST 1.1);
- ECOG Performance Status of 0 or 1;
Key exclusion criteria (13 listed)
- Accompanied by untreated or active central nervous system (CNS) tumour metastasis;
- Had other malignancies within five years prior to first use of the investigational drug;
- With severe cardiovascular and cerebrovascular disease；
- Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications;
- The presence of uncontrolled pleural, abdominal or pericardial effusion;
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-7058 capsule/ HRS-7058 tabletHRS-7058 capsule/ HRS-7058 tablet | Drug | HRS-7058 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
maximum tolerated dose (MTD)
Time frame: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Phase II recommended dose (RP2D)
Time frame: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Safety endpoints: adverse events (AE)
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 21 months]
5 secondary outcomes
Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion
Time frame: From the beginning of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion
Time frame: From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion
Time frame: From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: overall survival (OS)
Time frame: From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 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 21 Jan 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 1 study testing HRS-7058 capsule/ HRS-7058 tablet in people with Advanced Malignant Tumour, 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 10 inclusion and 13 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 21 Jan 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?
Contact Yifan Zhang (+0518-81220121, yifan.zhang.yz597@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months). 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 21 Jan 2026.