BridgeMD
New treatment option for Advanced Malignant Tumour
Official title A Phase II Clinical Study of HRS-7058 in Combination With Antitumor Drugs in Patients With Advanced Malignant Tumour
ClinicalTrials.gov ID: NCT06915142
What this study is testing
What is HRS-7058 + SHR-1316?
HRS-7058 + SHR-1316 is an investigational medicine, being studied as a potential treatment for advanced malignant tumour.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The people 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;
- people 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;
You likely can't join if
- 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;
See the full eligibility criteria
- The people 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;
- people 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;
- Be able to ingest drugs and be able to comply with trial and follow-up procedures;
- Adequate bone marrow and organ function;
- Female people 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 people...
- 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;
- 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 people unsuitable for...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.