Testing HRS-7058 with cancer drugs for advanced tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical study evaluates the safety, tolerability, and efficacy of HRS-7058 in combination with various antitumor drugs in patients with advanced malignant tumors. The study involves dose escalation and extension to determine the optimal dosing and effectiveness of HRS-7058 alongside treatments like SHR-1316 and platinum-containing chemotherapy. Participants will be monitored for their response to the treatment and any adverse effects experienced during the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting
• Tianjin Cancer Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Sida Zhu
• Email: sida.zhu.sz15@hengrui.com
• Phone: +0518-81220121

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• HRS-7058 for adults with advanced malignant tumors

  This phase I effort will try different doses of the oral drug HRS-7058 in adults with advanced solid tumors to see if it is safe, how the body processes it, and whether it shows any anti-tumor effect.

  Recruiting Phase 1 Shandong Suncadia Medicine Co., Ltd. · Tianjin, Tianjin Municipality · NCT06383871

• Puxitatug samrotecan versus chemotherapy for B7-H4–positive advanced endometrial cancer

  This trial will test whether puxitatug samrotecan helps people with B7‑H4–positive advanced or metastatic endometrial cancer live longer or keep their cancer from getting worse compared with standard chemotherapy after platinum and PD‑1/PD‑L1 treatment.

  Recruiting at 212 sites Phase 3 AstraZeneca · Tucson, Arizona and 319 other locations · NCT07044336

• Validation of the O-bridge Protocol for Oral Cavity Reconstruction

  This study is testing a new method to help people who have had surgery for tumors in their mouth regain better function and appearance by using a special protocol for jaw reconstruction.

  Recruiting at 5 sites AZ Sint-Jan AV · Antwerp and 4 other locations · NCT04007783

• Testing different doses of BI 3968621 alone or with ezabenlimab in adults with advanced cancer

  This study tests whether BI 3968621, alone or with ezabenlimab, can be given safely at different doses to adults with advanced solid tumors and whether it can slow or shrink tumors.

  Recruiting at 3 sites Phase 1 Boehringer Ingelheim · Sarasota, Florida and 9 other locations · NCT07851103

• LBL-024 combined with chemotherapy and immunotherapy for advanced gastric or gastroesophageal junction adenocarcinoma

  This study will test whether adding LBL-024 to capecitabine, oxaliplatin, and tislelizumab helps adults with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

  Recruiting Phase 2 Nanjing Leads Biolabs Co.,Ltd · Beijing, Beijing Municipality and 6 other locations · NCT07390383

• LBL-024 combination treatment for advanced esophageal squamous cell carcinoma (Phase II, Substudy 03)

  This trial tries LBL-024 combined with chemotherapy and immunotherapy in adults with advanced esophageal squamous cell carcinoma to see if it better controls tumors or prolongs benefit.

  Recruiting at 6 sites Phase 2 Nanjing Leads Biolabs Co.,Ltd · Beijing, Beijing Municipality and 6 other locations · NCT07331155

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.