Evaluating HYP-6589 for advanced solid tumors and NSCLC

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

This study is testing a new drug called HYP-6589 to see if it can safely help people with advanced solid tumors and those with advanced non-small cell lung cancer who have specific gene changes.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 115 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06712680 on ClinicalTrials.gov

What this trial studies

This multi-center, open-label phase I/II study aims to assess the safety, efficacy, and pharmacokinetics of HYP-6589 as a monotherapy for advanced solid tumors and in combination with tyrosine kinase inhibitors for patients with advanced non-small cell lung cancer (NSCLC) who have driver gene positivity. The study consists of a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase to evaluate preliminary anti-tumor activity. Participants will be closely monitored for safety and tolerability throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with unresectable or metastatic advanced solid tumors and measurable lesions.

Not a fit: Patients with resectable tumors or those who do not have driver gene positivity may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors and NSCLC, potentially improving outcomes for those with specific genetic markers.

How similar studies have performed: Other studies have shown promise in targeting driver genes in NSCLC, suggesting that this approach may be effective.

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;

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Li Zhang, Doctor

Conditions Solid Tumor