Phase 1 / Phase 2: testing Test Product HYP-6589 for Solid Tumor
This is a multi-center , open-label, phase 1/2 study to measure the safety, how well it works, and pharmacokinetic (PK) characteristics of HYP-6589 in this drug alone in advanced solid tumors and combination with tyrosine kinase inhibitors in patients with advanced NSCLC with target-driven gene positivity.
Official registry: https://clinicaltrials.gov/study/NCT06712680 · Sichuan Huiyu Pharmaceutical Co., Ltd · enrollment listed as 115
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Test Product HYP-6589, or Osimertinib. The registry lists allocation as na. This is a multi-center , open-label, phase 1/2 study to measure the safety, how well it works, and pharmacokinetic (PK) characteristics of HYP-6589 in this drug alone in advanced solid tumors and combination with tyrosine kinase inhibitors in patients with advanced NSCLC with target-driven gene positivity.
They plan to enroll about 115 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase I/II , Open-label, Multi-center, Multi-cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HYP-6589 Monotherapy in Advanced Solid Tumors and Combination With Tyrosine Kinase Inhibitors in Patients With Advanced NSCLC With Target-driven Gene Positivity
Interventions: Test Product HYP-6589, Osimertinib
Primary outcome (registry wording): Dose Escalation (Part One): Incidence and Nature of Dose-Limiting Toxicity (DLT)
Who it is for (from inclusion criteria)
- Ages 18 Years to 80 Years
- ≥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;
Who the registry excludes
- Participants who have received other investigational drugs or participated in treatment 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 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;
Public study contact (from the registry)
Li Zhang, Doctor
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (recruiting)
FAQ about this NCT record
Is NCT06712680 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06712680?
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06712680?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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