This is a multicenter, open-label, phase I/Ⅱ study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic(PD) characteristics of HY0001a for injection in participants with advanced solid tumors.
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 ≤75 years old, gender: male or female;
Patients have histological or cytological diagnosis with advanced solid tumors, cann't benefit from existing standard treatment options;The solid tumors included in the dose-expansion phase are as follows: Cohort 1: Esophageal cancer (patients who have previously received at least two lines of standard therapy);Cohort 2: Non-small cell lung cancer (patients who have previously received at least two lines of standard therapy);Cohort 3: Other tumors, such as cervical cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, breast cancer, etc. (patients who have failed or are intolerant to standard therapy).
In the dose-escalation phase, patients must have evaluable tumor lesions; in the dose-expansion phase, patients must have at least one measurable tumor lesion (according to RECIST 1.1 version);
Having received anti-tumor treatments such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, or immunotherapy within 4 weeks prior to the first administration of the study drug
Known history of severe allergic reactions, or individuals who have experienced an allergic reaction to any of the excipients in the formulation of HY0001a for injection
Participants who have previously failed treatment with antibody-drug conjugates (ADCs) that use microtubule inhibitors (Monomethyl auristatin E/Monomethyl auristatin F) as toxins
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;
Single group
Test product HY0001a for injection
DrugHY0010a for injection should be administered at the recommended dosage
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.
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
Dose Expansion (Part Two): Objective Response Rate (ORR)
Proportion of participants who have a confirmed Complete Response (CR) or a Partial Response (PR)
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
Dose Escalation and Expansion: Assessment of HY0001a for injection, HY0001a-TAb, and free monomethyl auristatin E (MMAE, i.e., the toxin) Cmax
Maximum concentration observed (Cmax) observed from the pharmacokinetic profile
Dose Escalation and Expansion: Assessment of HY0001a for injection, HY0001a-TAb, and free MMAE (i.e., the toxin) AUC
Area under the concentration versus time curve calculated using the trapezoidal method
Dose Escalation and Expansion: Assessment of HY0001a for injection, HY0001a-TAb, and free MMAE (i.e., the toxin) T1/2
The time it takes for half the drug concentration to be eliminated calculated using slope of the terminal line
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