AzTrials
AzTrials

Advanced Malignant TumourPhase 2NCT06915142

A Phase II Clinical Study of HRS-7058 in Combination With Antitumor Drugs in Patients With Advanced Malignant Tumour

A Phase 2 study testing HRS-7058 + SHR-1316, HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy and HRS-7058 + Cetuximab in people with Advanced Malignant Tumour, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a multicentre, open phase II clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in combination with antitumor drugs in subjects with advanced malignant tumour. To evaluate the safety, tolerability and efficacy of HRS-7058 in combination with antitumor drugs. 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 + SHR-1316, HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy and HRS-7058 + Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
2 sitesChina
Study dates
28 Apr 2025to Oct 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

  • 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 unresectable 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 12 weeks;
Show all 9Show fewer
  • Be able to ingest drugs and be able to comply with trial and follow-up procedures;
  • Adequate bone marrow and organ function;
  • Female subjects of childbearing potential must undergo a serum pregnancy test within 7 days before the first administration of the study drug, and the result must be negative; and they must not be lactating. Female subjects of childbearing potential and male subjects whose partners are females of childbearing potential must agree to comply with contraceptive requirements from the time of signing the informed consent form until 5 months after the last administration of the study drug (for male subjects) or 8 months after the last administration of the study drug (for female subjects).

Who cannot join

  • Accompanied by untreated or active central nervous system (CNS) tumour metastasis;
  • Antitumor therapy within 28 days prior to initial use of the investigational drug;
  • The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤ grade 1;
  • With known or suspected interstitial pneumonia;
  • With severe cardiovascular and cerebrovascular disease
  • Had other malignancies within five years prior to first use of the investigational drug;
Show all 14Show fewer
  • Severe infection within 28 days prior to first use of the investigational drug;
  • History of immune deficiency;
  • Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications;
  • The presence of uncontrolled pleural, abdominal or pericardial effusion;
  • Had undergone major organ surgery within 28 days prior to the first use of the study drug;
  • Women during pregnancy or lactation;
  • Known allergies and contraindications to the investigational drug or any of its components;
  • According to the judgment of the investigator, there are any other circumstances that may increase the risks of participating in the study, interfere with the study results, or make the subjects unsuitable for participating in this study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sida Zhu contact

+0518-81220121

sida.zhu.sz15@hengrui.com

Linan Wang contact

+0518-81220121

linan.wang@hengrui.com

China2 sites, 2 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100021

    Yan Wang

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

    Dingzhi Huang

    Recruiting

Other trials in China

About this study

Official title: An Phase II Clinical Study on the Safety, Tolerability and Efficacy of HRS-7058 in Combination With Antitumor Drugs in Subjects With Solid Tumors

This study is a multicentre, open phase II clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in combination with antitumor drugs in subjects with advanced malignant tumour. To evaluate the safety, tolerability and efficacy of HRS-7058 in combination with antitumor drugs.

Being tested
HRS-7058 + SHR-1316, HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy, HRS-7058 + Cetuximab, HRS-7058 + SHR-1826, HRS-7058 + SHR-1826 + SHR-1316

What participants receive

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

  • HRS-7058 + SHR-1316Drug

    HRS-7058 + SHR-1316

  • HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapyDrug

    HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy

  • HRS-7058 + CetuximabDrug

    HRS-7058 + Cetuximab

  • HRS-7058 + SHR-1826Drug

    HRS-7058 + SHR-1826

  • HRS-7058 + SHR-1826 + SHR-1316Drug

    HRS-7058 + SHR-1826 + SHR-1316

  • HRS-7058 + SHR-A1202Drug

    HRS-7058 + SHR-A1202

  • HRS-7058 + BP102Drug

    HRS-7058 + BP102

  • HRS-7058 + SHR-9839Drug

    HRS-7058 + SHR-9839

  • HRS-7058 +SHR-A2102 +SHR-1316Drug

    HRS-7058 +SHR-A2102 +SHR-1316

  • HRS-7058 +SHR-9839(sc)+SHR-1316Drug

    HRS-7058 +SHR-9839(sc)+SHR-1316

  • HRS-7058 +SHR-1316 +BP102Drug

    HRS-7058 +SHR-1316 +BP102

  • HRS-7058 +SHR-A2102 +BP102Drug

    HRS-7058 +SHR-A2102 +BP102

  • HRS-7058 +SHR-A2102 +SHR-1316 +BP102Drug

    HRS-7058 +SHR-A2102 +SHR-1316 +BP102

Study groups in NCT06915142
Study groupRoleWhat they receive
HRS-7058 + SHR-1316ExperimentalNot described
Receives: Drug: HRS-7058 + SHR-1316
HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapyExperimentalNot described
Receives: Drug: HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy
HRS-7058 + CetuximabExperimentalNot described
Receives: Drug: HRS-7058 + Cetuximab
HRS-7058 + SHR-1826ExperimentalNot described
Receives: Drug: HRS-7058 + SHR-1826
HRS-7058 + SHR-1826 + SHR-1316ExperimentalNot described
Receives: Drug: HRS-7058 + SHR-1826 + SHR-1316
HRS-7058 + SHR-A1202ExperimentalNot described
Receives: Drug: HRS-7058 + SHR-A1202
HRS-7058 + BP102ExperimentalNot described
Receives: Drug: HRS-7058 + BP102
HRS-7058 + SHR-9839ExperimentalNot described
Receives: Drug: HRS-7058 + SHR-9839
HRS-7058 +SHR-A2102 +SHR-1316ExperimentalNot described
Receives: Drug: HRS-7058 +SHR-A2102 +SHR-1316
HRS-7058 +SHR-9839(sc)+SHR-1316ExperimentalNot described
Receives: Drug: HRS-7058 +SHR-9839(sc)+SHR-1316
HRS-7058 +SHR-1316 +BP102ExperimentalNot described
Receives: Drug: HRS-7058 +SHR-1316 +BP102
HRS-7058 +SHR-A2102 +BP102ExperimentalNot described
Receives: Drug: HRS-7058 +SHR-A2102 +BP102
HRS-7058 +SHR-A2102 +SHR-1316 +BP102ExperimentalNot described
Receives: Drug: HRS-7058 +SHR-A2102 +SHR-1316 +BP102

What is being measured

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

  1. Dose-limiting toxicity (DLT) (Dose Escalation and Dose Expansion)

    Measured: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months

  2. Safety endpoints: adverse events (AE) (Dose Escalation and Dose Expansion)

    Measured: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]

  3. Phase II recommended dose (RP2D)(Dose Escalation and Dose Expansion)

    Measured: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]

  4. Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion (Efficacy Expansion)

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months

Secondary outcomes (10)

  1. Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion)

    Measured: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months

  2. Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion)

    Measured: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months

  3. Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion)

    Measured: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months

  4. Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion)

    Measured: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months

  5. Efficacy endpoints: overall survival (OS)(Dose Escalation and Dose Expansion)

    Measured: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months

  6. Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion (Efficacy Expansion)

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months

  7. Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion (Efficacy Expansion)

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months

  8. Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion (Efficacy Expansion)

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months

  9. Efficacy endpoints: overall survival (OS) (Efficacy Expansion)

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months

  10. Safety endpoints: adverse events (AE)(Efficacy Expansion)

    Measured: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2025
  2. Study start28 Apr 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionOct 2027 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06915142
Sponsor's protocol ID
HRS-7058-201
Status last verified
Apr 2025
First submitted
1 Apr 2025
Last updated
26 Jan 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 2 study testing HRS-7058 + SHR-1316, HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy and HRS-7058 + Cetuximab in people with Advanced Malignant Tumour, 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 9 inclusion and 14 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 26 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 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 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 Sida Zhu (+0518-81220121, sida.zhu.sz15@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) (Dose Escalation and Dose Expansion) (time frame: From the beginning of first patient in (FPI) to the end of dose expansion 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?

On the ClinicalTrials.gov record for NCT06915142.

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 26 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in