New pill takes on advanced cancers in early trial
NCT ID NCT07339748
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental pill called ZL-85FA in people with advanced solid tumors (breast, ovarian, fallopian tube, primary peritoneal, or prostate cancer) that have not responded to standard treatments. The trial has two phases: first, finding a safe dose, then checking for early signs of tumor shrinkage. About 51 participants will take the pill once daily, and researchers will monitor safety and how well the drug works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ZL-85FA tablets (an experimental oral drug)
- What this could lead to
- If successful, this could point toward a new oral treatment option for certain advanced cancers like breast, ovarian, or prostate cancer.
- What could go wrong
- This is an early-phase trial with only 51 participants, so it is too soon to know if the drug works. Side effects are unknown, and many early cancer drugs fail to show benefit.
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 51 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 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 75 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: \- 1.Voluntarily joining this study, signing informed consent form, good compliance, and able to cooperate with follow-up; 2.Age: \>=18 years old and \<=75 years old (including boundary values, calculated on the day of signing informed consent), gender not limited; 3.Patients with advanced breast cancer, ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and prostate cancer confirmed by pathological histology or cytology. 4.ECOG \<= 1 point; 5.Expected survival period \>= 12 weeks; 6.Sufficient organ functio; 7. All acute toxicity reactions of previous anti-cancer treatments or surgical procedures have been relieved to baseline severity or NCI-CTCAE version 5.0 \<= 1 (except for hair loss or other toxicity that the researcher considers to be of no safety risk to the patient); 8.Women and men of childbearing age should agree to take effective contraceptive measures (hormone or barrier therapy or abstinence) 10.During the study period and within 6 months after the end of the study; Female patients of childbearing age who have a negative serum or urine pregnancy test within 7 days before administration and must be non lactating patients. Exclusion Criteria: * 1.It is known that there is severe allergy to the investigational drug or any of its excipients (lactose, microcrystalline cellulose, low substituted hydroxypropyl cellulose, glyceryl behenate, hydroxypropyl methylcellulose, film coated premix (gastric soluble)); 2.Currently or previously suffering from other malignant tumors (excluding fully treated basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ), unless curative treatment has been carried out and there is evidence of no recurrence or metastasis within the past 5 years; 3.Symptomatic central nervous system (CNS) metastases or asymptomatic CNS metastases requiring steroid treatment within 2 weeks prior to the first use of the study drug. Subjects with malignant meningitis or leptomeningeal spread; 4.Have received the last systemic anti-tumor treatment (chemotherapy, targeted therapy, immunotherapy, biologics, etc.) within 4 weeks before the first administration, with mitomycin or nitrosamines within 6 weeks, and small molecule targeted drugs within 2 weeks before the first administration of the study drug or within 5 half lives of the known drug (whichever is longer); Local palliative radiotherapy within 2 weeks prior to the first use of the study drug; The last administration of endocrine therapy is within 2 weeks before the first administration of the investigational drug (excluding necessary drug castration treatment for patients with metastatic castration resistant prostate cancer); Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications were received within 2 weeks before the first administration of the study drug; 5.Individuals with severe infections within 4 weeks prior to the first administration, or those with active infections requiring oral or intravenous antibiotic treatment within 2 weeks prior; Individuals with active pulmonary tuberculosis who have undergone sufficient treatment before their first medication and have stopped anti tuberculosis treatment for at least 3 months are eligible for enrollment; 6.Receive blood transfusion, recombinant human thrombopoietin, recombinant human interleukin-11, erythropoietin, granulocyte colony-stimulating factor and other treatments within 2 weeks before the first use of the investigational drug; 7.Patients who have received systemic corticosteroid (prednisone\>10 mg/day or equivalent doses of similar drugs, continuously used for more than 4 days) or other immunosuppressive therapy within 14 days before the first administration; Excluding the following situations: treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids, and short-term prophylactic treatment with corticosteroids such as contrast agents. 8.There are uncontrollable or significant cardiovascular and cerebrovascular diseases, including: 1. Within 6 months prior to the first use of medication, there is a New York Heart Association (NYHA) grade II or higher congestive heart failure, unstable angina pectoris, myocardial infarction, or arrhythmia requiring treatment during screening, with a left ventricular ejection fraction (LVEF)\<50%; 2. Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, and undifferentiated cardiomyopathy); 3. Other cardiovascular and cerebrovascular diseases that have been determined by researchers to be unsuitable for inclusion. 9.Uncontrollable electrolyte imbalances may affect the efficacy of QTc drugs , but retesting after intervention therapy is allowed; 10.Those who have undergone major surgeries requiring general anesthesia or have not withdrawn from other clinical trials within 4 weeks prior to the first administration; Within 2 weeks prior to enrollment, the patient has undergone surgery requiring local anesthesia/epidural anesthesia and has not yet recovered (excluding tissue biopsy); 11.he following active infections with clinical significance, including hepatitis B (HBV) and hepatitis C (HCV). Active hepatitis B is defined as: subjects who are HBsAg positive or HBcAb positive and whose HBV DNA is higher than the lower limit of detection (i.e. the upper limit of the normal value in the laboratory of each research center), if they reach the negative level of HBV DNA after antiviral treatment and receive antiviral drugs at least 2 weeks before the first administration, those who are willing to continue to receive anti hepatitis B virus treatment during the study period are allowed to be included in the study. Active hepatitis C is defined as those who are HCV antibody positive and whose HCV RNA is higher than the lower limit of detection (the upper limit of the normal value). Treponema pallidum antibody (TP Ab) positive and syphilis non-specific antibody titer (RPR) positive; 12.History of immunodeficiency, including positive human immunodeficiency virus (HIV) antibody test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 13.Patients with swallowing difficulties, chronic diarrhea, or oral absorption disorders; 14. Patients with bleeding tendency (for example, active peptic ulcer, recent hemorrhagic stroke \[within 6 months before screening\], proliferative diabetes retinopathy); 15.Within the first 4 weeks of enrollment, participated in other interventional clinical trials; 16.Other serious acute or chronic medical or psychiatric disorders or laboratory abnormalities that may increase the risk of participation in the study or increase the risk associated with the administration of the study drug, or interfere with the study results, as well as other situations where the researcher deems the patient unsuitable to participate in this study.
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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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The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors