A Phase I/II Study of HYP-6589 Monotherapy in Treating Ad... | NCT06712680

Status Module

Label	Type	Description	Intervention Names
Test product HYP-6589	Experimental	HYP-6589 should be administered orally at the recommended dosage	Drug: Test Product HYP-6589

Name	Type	Description	Arm Group Labels	Other Names
Test Product HYP-6589	Drug	HYP-6589 should be administered orally at the recommended dosage	Test product HYP-6589

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose Escalation (Part One): Incidence and Nature of Dose-Limiting Toxicity (DLT)	Dose-Limiting Toxicity (DLT) will be defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	24 days during the first 4-week cycle
Dose Escalation (Part One): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)	Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0	Up to 2 years
Dose Escalation (Part One): Other safety indicators	Adverse events (AE), physical examination, vital signs, electrocardiogram (ECG) and laboratory test results that occur during the treatment	Up to 2 years
Dose Expansion (Part Two): Objective Response Rate (ORR)	Proportion of participants who have a confirmed Complete Response (CR) or a Partial Response (PR)	Up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
Dose Expansion (Part Two): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)	Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0	Up to 2 years

Eligibility Module

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;