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New treatment option for Advanced Malignant Tumour
Official title A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour
ClinicalTrials.gov ID: NCT06383871
What this study is testing
What is HRS-7058 capsule/ HRS-7058 tablet?
HRS-7058 capsule/ HRS-7058 tablet is an investigational medicine, given as a pill taken by mouth, 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 I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058.
- Phase 1: an early, usually small safety study
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 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;
- Had other malignancies within five years prior to first use of the investigational drug;
- With severe cardiovascular and cerebrovascular disease；
- Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications;
- The presence of uncontrolled pleural, abdominal or pericardial effusion;
- Severe infection within 4 weeks prior to initiation of study treatment;
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 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 3 months;
- Be able to ingest drugs and be able to comply with trial and follow-up procedures;
- Adequate bone marrow and organ function;
- Fertile women must agree to abstain from sex (abstaining from heterosexual intercourse) or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the...
- For male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly...
- Accompanied by untreated or active central nervous system (CNS) tumour metastasis;
- Had other malignancies within five years prior to first use of the investigational drug;
- With severe cardiovascular and cerebrovascular disease；
- Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications;
- The presence of uncontrolled pleural, abdominal or pericardial effusion;
- Severe infection within 4 weeks prior to initiation of study treatment;
- History of immune deficiency;
- The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤ grade 1;
- Antitumor therapy such as chemotherapy, biotherapy, targeted therapy, immunotherapy, or other unmarketed investigational drug therapy within 4 weeks prior to initial use of the investigational drug;
- Had undergone major organ surgery within 4 weeks prior to the first use of the study drug;
- Women who are pregnant, breastfeeding, or who plan to become pregnant within one week of their last use of the study drug during the study period;
- Known allergies and contraindications to the investigational drug or any of its components;
- In the investigator's judgment, the people had other factors that could have affected the study results or led to the forced termination of the study.
The study team makes the final eligibility decision.
Where it's taking place
- 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 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.