New drug combo targets tough cancers
NCT ID NCT06712680
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called HYP-6589, alone or with other cancer drugs, in people with advanced solid tumors that cannot be removed by surgery or have spread. The goal is to see if the drug is safe and shrinks tumors. About 115 adults aged 18–80 with certain genetic markers will take part. This is an early-stage trial focused on controlling the disease, not curing it.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 115 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Voluntarily sign an informed consent form, understand the study and be willing and able to follow and complete all trial procedures; * ≥18 years old and ≤80 years old, gender: male or female; * Histological or cytological confirmation of unresectable and/or metastatic advanced solid tumors; * At least one measurable lesion (according to RECIST 1.1 version); * Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1; * Life expectancy ≥3 months; * Participant must have adequate main organ function; * Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing and be willing to use effective birth control/contraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Male patients must agree to have no sperm donation plans and to use effective contraceptive methods during the study period until 6 months after the last dose of the study. Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile. Exclusion Criteria: * Participants who have received other investigational drugs or participated in interventional medical device studies within 4 weeks prior to the first administration of the study drug; * Participants who have received (attenuated) live vaccines within 4 weeks prior to the first administration of the study drug; * Participants who have undergone major organ surgery (excluding biopsy) within 4 weeks prior to the first administration of the study drug or have experienced significant trauma, or who require elective major organ surgery (excluding biopsy) during the study period; * Participants who, based on computerized tomography (CT) or magnetic resonance imaging (MRI) examinations conducted during the screening period and before radiological assessment, have uncontrolled, unstable, or active central nervous system (CNS) metastases; * Participants with clinically uncontrollable hypertension (defined in this protocol as having a systolic blood pressure \> 150 mmHg and/or a diastolic blood pressure \> 100 mmHg despite antihypertensive treatment, and which is considered clinically significant by the investigator); * Participants who have received allogenic tissue/organ transplants in the past; * Participants with active infections deemed inappropriate for entry into the study by the investigator; * Participants with uncontrolled third-space effusion requiring clinical intervention; * Participants with a history of drug abuse or medical, psychological, or social conditions that may interfere with study participation or impair the assessment of study outcomes; * Participants with known gastrointestinal (GI) dysfunction or GI diseases that are likely to significantly affect the absorption or metabolism of oral medications (e.g., dysphagia, active upper gastrointestinal ulcer, intestinal obstruction, nausea, vomiting, and diarrhea of grade 3 or higher that persist despite optimal supportive care within 3 days); * Participant whose toxicities from previous anti-cancer therapy have not resolved, defined as toxicity (hair loss excluded) that has not resolved to grade ≤1 (CTCAE 5.0 version, peripheral neuropathy, ≤grade 2; exclusion criteria specified); * Female participants who are breastfeeding or have positive urine or blood pregnancy test results during the screening period; female participants who have a planned pregnancy, sperm donation, or egg donation during the study period or within 6 months after the last study drug administration; * Known history of hypersensitivity to any of the components of the test formulation. * Participants who have had other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First human test of BI 4060107 aims to find safe dose for Hard-to-Treat tumors
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Can a new drug shield kidneys from chemotherapy damage?
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers