BridgeMD
New treatment option for Recurrent Ovarian Cancer
Official title HS-10502 Combination Treatment in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06769425
What this study is testing
What is HS-10502 + NHA?
HS-10502 + NHA is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for recurrent ovarian cancer.
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
- HS-10502 is a PARP1-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 Combination Treatment in subjects with advanced solid tumors.
- 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 and older
You may be able to join if
- Males or females aged 18 years or older (≥18 years).
- Patients diagnosed with pathologically confirmed advanced solid tumors.
- people have at least one target lesion as assessed per the RECIST 1.1.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose.
- Have a life expectancy of at least 12 weeks.
You likely can't join if
- Have received or is currently receiving the following treatment: PARPi/B7-H4/B7-H3-targeted therapies;
- Have received or is currently receiving the following treatment: PARPi/B7-H4/B7-H3-targeted therapies;
- Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within...
- Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events due to prior anti-tumor therapy.
- Presence of pleural/abdominal effusion requiring clinical intervention.
- Known history of other primary malignancy.
See the full eligibility criteria
- Males or females aged 18 years or older (≥18 years).
- Patients diagnosed with pathologically confirmed advanced solid tumors.
- people have at least one target lesion as assessed per the RECIST 1.1.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose.
- Have a life expectancy of at least 12 weeks.
- Female people of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent until 6 months after the last dose; male people must agree to...
- Female people must have a negative pregnancy test within 7 days prior to the first dose (for people with tumor related abnormal elevation of human chorionic gonadotropin [HCG], an ultrasound of uterus and appendages...
- Subject must be voluntarily enrolled in this clinical trial, be able to understand the study procedures and to sign written informed consent.
- Have received or is currently receiving the following treatment: PARPi/B7-H4/B7-H3-targeted therapies;
- Have received or is currently receiving the following treatment: PARPi/B7-H4/B7-H3-targeted therapies;
- Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 14 days prior to the first dose of study drug; or need to continue...
- Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events due to prior anti-tumor therapy.
- Presence of pleural/abdominal effusion requiring clinical intervention.
- Known history of other primary malignancy.
- Evidence of brain metastasis and/or cancerous meningitis
- Inadequate bone marrow reserve or hepatic/renal functions.
- Cardiological examination abnormality.
- Severe, uncontrolled or active cardiovascular disorders.
- Serious or poorly controlled diabetes.
- Serious or poorly controlled hypertension.
- Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose of study treatment.
- Serious infections within 4 weeks prior to the first dose.
- Have received systemic glucocorticoid therapy for more than 7 days within 28 days prior to the first dose study treatment, or require chronic (≥ 7 days) use of systemic glucocorticoids during the study, or have other...
- Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus infection, etc.
- Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis.
- Any moderate or severe lung diseases that may interfere with the detection and treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.
- History of severe neurological or psychiatric disorder.
- Pregnant or breast-feeding women or women who intend to become pregnant during the study.
- Attenuated live vaccination within 4 weeks prior to the first dose.
- people with autoimmune disease that is active or is likely to recur.
- people with gastrointestinal fistula, visceral fistula, gastrointestinal perforation, or abdominal abscess, or with symptoms/signs of intestinal obstruction within 6 months prior to the first dose of study drug.
- people unlikely to comply with study procedures, restrictions and requirement as determined by the investigator.
- people with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai 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.