NCT06712680 A Phase I/II Study of HYP-6589 Monotherapy in Treating Advanced Solid Tumors and in Combination With Tyrosine Kinase Inhibitors in Treating Patients With Advanced NSCLC Positive for Driver Genes
| NCT ID | NCT06712680 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sichuan Huiyu Pharmaceutical Co., Ltd |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 115 participants |
| Start Date | 2024-11-27 |
| Primary Completion | 2028-04-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 115 participants in total. It began in 2024-11-27 with a primary completion date of 2028-04-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multi-center , open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of HYP-6589 in monotherapy in advanced solid tumors and combination with tyrosine kinase inhibitors in patients with advanced NSCLC with target-driven gene positivity.
Eligibility Criteria
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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06712680 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06712680 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06712680 currently recruiting?
Yes, NCT06712680 is actively recruiting participants. Contact the research team at zhangli@sysucc.org.cn for enrollment information.
Where is the NCT06712680 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06712680 clinical trial?
NCT06712680 is sponsored by Sichuan Huiyu Pharmaceutical Co., Ltd. The trial plans to enroll 115 participants.