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RecruitingNCT06915142Updated Jan 26, 2026

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

A Phase 2 interventional study of HRS-7058 + SHR-1316 and HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy in Advanced Malignant Tumour, sponsored by Shandong Suncadia Medicine Co., Ltd.. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-26.

Sponsored by Shandong Suncadia Medicine Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Malignant Tumour
03

In context

Lead sponsor

Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 86 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;
  2. 18 to 75 years old (including both ends), gender is not limited;
  3. Subjects with unresectable locally advanced or metastatic solid tumour confirmed by histopathology;
  4. Having at least one evaluable or measurable lesion according to the solid tumour response Evaluation Criteria (RECIST 1.1);
  5. ECOG Performance Status of 0 or 1;
  6. The expected survival time is more than 12 weeks;
  7. Be able to ingest drugs and be able to comply with trial and follow-up procedures;
  8. Adequate bone marrow and organ function;
  9. 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).

Exclusion criteria

Exclusion Criteria:

  1. Accompanied by untreated or active central nervous system (CNS) tumour metastasis;
  2. Antitumor therapy within 28 days prior to initial use of the investigational drug;
  3. The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤ grade 1;
  4. With known or suspected interstitial pneumonia;
  5. With severe cardiovascular and cerebrovascular disease
  6. Had other malignancies within five years prior to first use of the investigational drug;
  7. Severe infection within 28 days prior to first use of the investigational drug;
  8. History of immune deficiency;
  9. Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications;
  10. The presence of uncontrolled pleural, abdominal or pericardial effusion;
  11. Had undergone major organ surgery within 28 days prior to the first use of the study drug;
  12. Women during pregnancy or lactation;
  13. Known allergies and contraindications to the investigational drug or any of its components;
  14. 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    HRS-7058 + SHR-1316

    Drug: HRS-7058 + SHR-1316

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

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

  • Experimental
    HRS-7058 + Cetuximab

    Drug: HRS-7058 + Cetuximab

  • Experimental
    HRS-7058 + SHR-1826

    Drug: HRS-7058 + SHR-1826

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

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

  • Experimental
    HRS-7058 + SHR-A1202

    Drug: HRS-7058 + SHR-A1202

  • Experimental
    HRS-7058 + BP102

    Drug: HRS-7058 + BP102

  • Experimental
    HRS-7058 + SHR-9839

    Drug: HRS-7058 + SHR-9839

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

    Drug: HRS-7058 +SHR-A2102 +SHR-1316

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

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

  • Experimental
    HRS-7058 +SHR-1316 +BP102

    Drug: HRS-7058 +SHR-1316 +BP102

  • Experimental
    HRS-7058 +SHR-A2102 +BP102

    Drug: HRS-7058 +SHR-A2102 +BP102

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

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

Interventions

  • DrugHRS-7058 + SHR-1316

    HRS-7058 + SHR-1316

  • DrugHRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy

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

  • DrugHRS-7058 + Cetuximab

    HRS-7058 + Cetuximab

  • DrugHRS-7058 + SHR-1826

    HRS-7058 + SHR-1826

  • DrugHRS-7058 + SHR-1826 + SHR-1316

    HRS-7058 + SHR-1826 + SHR-1316

  • DrugHRS-7058 + SHR-A1202

    HRS-7058 + SHR-A1202

  • DrugHRS-7058 + BP102

    HRS-7058 + BP102

  • DrugHRS-7058 + SHR-9839

    HRS-7058 + SHR-9839

  • DrugHRS-7058 +SHR-A2102 +SHR-1316

    HRS-7058 +SHR-A2102 +SHR-1316

  • DrugHRS-7058 +SHR-9839(sc)+SHR-1316

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

  • DrugHRS-7058 +SHR-1316 +BP102

    HRS-7058 +SHR-1316 +BP102

  • DrugHRS-7058 +SHR-A2102 +BP102

    HRS-7058 +SHR-A2102 +BP102

  • DrugHRS-7058 +SHR-A2102 +SHR-1316 +BP102

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

06

What researchers measure

Primary outcomes

  1. 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

  2. Safety endpoints: adverse events (AE) (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]

  3. Phase II recommended dose (RP2D)(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]

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

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

Secondary outcomes

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

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

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

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

  5. Efficacy endpoints: overall survival (OS)(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

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

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

07

Study locations

2 of 2 sites recruiting
  • Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    Beijing, Beijing Municipality 100021, China
    • Yan Wang · Principal investigator
    Recruiting
  • Tianjin Cancer Hospital
    Tianjin, Tianjin Municipality 300060, China
    • Dingzhi Huang · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06915142
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Apr 8, 2025
Start date
Apr 28, 2025
Primary completion
Dec 2026 (estimated)
Completion
Oct 2027 (estimated)
Last update
Jan 26, 2026

Study contacts

Sida Zhu
Contact
sida.zhu.sz15@hengrui.com
+0518-81220121
Linan Wang
Contact
linan.wang@hengrui.com
+0518-81220121

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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