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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-28

Study Completion Date

2027-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial of HRS-6768 in Patients With Advanced Solid Tumors

NCT06925581

Advanced Solid Tumors

RECRUITING PHASE1/PHASE2

A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor

NCT07140393

Solid Tumor

NOT_YET_RECRUITING PHASE1/PHASE2

A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer

NCT05628870

Breast Cancer

RECRUITING PHASE1

A Study of HS-10342 in Chinese Patients With HR+/HER2- Advanced and/or Metastatic Breast Cancer

NCT05044988

HR+/HER2- Advanced and/or Metastatic Breast Cancer

UNKNOWN PHASE2

Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer

NCT06413745

HER2 Expression / Amplification in Patients With Biliary Tract Cancer

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Malignant Tumour

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HRS-7058 + SHR-1316

Group Type EXPERIMENTAL

HRS-7058 + SHR-1316

Intervention Type DRUG

HRS-7058 + SHR-1316

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

HRS-7058 + Cetuximab

Group Type EXPERIMENTAL

HRS-7058 + Cetuximab

Intervention Type DRUG

HRS-7058 + Cetuximab

HRS-7058 + SHR-1826

Group Type EXPERIMENTAL

HRS-7058 + SHR-1826

Intervention Type DRUG

HRS-7058 + SHR-1826

HRS-7058 + SHR-1826 + SHR-1316

Group Type EXPERIMENTAL

HRS-7058 + SHR-1826 + SHR-1316

Intervention Type DRUG

HRS-7058 + SHR-1826 + SHR-1316

HRS-7058 + SHR-A1202

Group Type EXPERIMENTAL

HRS-7058 + SHR-A1202

Intervention Type DRUG

HRS-7058 + SHR-A1202

HRS-7058 + BP102

Group Type EXPERIMENTAL

HRS-7058 + BP102

Intervention Type DRUG

HRS-7058 + BP102

HRS-7058 + SHR-9839

Group Type EXPERIMENTAL

HRS-7058 + SHR-9839

Intervention Type DRUG

HRS-7058 + SHR-9839

HRS-7058 +SHR-A2102 +SHR-1316

Group Type EXPERIMENTAL

HRS-7058 +SHR-A2102 +SHR-1316

Intervention Type DRUG

HRS-7058 +SHR-A2102 +SHR-1316

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

HRS-7058 +SHR-1316 +BP102

Group Type EXPERIMENTAL

HRS-7058 +SHR-1316 +BP102

Intervention Type DRUG

HRS-7058 +SHR-1316 +BP102

HRS-7058 +SHR-A2102 +BP102

Group Type EXPERIMENTAL

HRS-7058 +SHR-A2102 +BP102

Intervention Type DRUG

HRS-7058 +SHR-A2102 +BP102

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HRS-7058 + SHR-1316

Intervention Type DRUG

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

Intervention Type DRUG

HRS-7058 + Cetuximab

Intervention Type DRUG

HRS-7058 + SHR-1826

Intervention Type DRUG

HRS-7058 + SHR-1826 + SHR-1316

Intervention Type DRUG

HRS-7058 + SHR-A1202

Intervention Type DRUG

HRS-7058 + BP102

Intervention Type DRUG

HRS-7058 + SHR-9839

Intervention Type DRUG

HRS-7058 +SHR-A2102 +SHR-1316

Intervention Type DRUG

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

Intervention Type DRUG

HRS-7058 +SHR-1316 +BP102

Intervention Type DRUG

HRS-7058 +SHR-A2102 +BP102

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No