This trial is a first-in-human, multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of KY-0301 as monotherapy in patients with advanced solid tumors. This trial will be conducted at approximately multi-sites nationwide, and approximately110\~212 participants with unresectable locally advanced or metastatic solid tumors will be invited to participate. The study consists of three parts: Phase I dose escalation \& dose expansion phases of KY-0301 as monotherapy, Phase II cohort expansion phase of KY-0301 as monotherapy.
Know the trial information before the start of the study and voluntarily sign an informed consent form (ICF).
Aged ≥ 18 years, male or female.
Agree to follow and be capable of completing all study procedures.
Female weight > 45 kg, male weight > 50 kg, with a BMI ≥18 kg/m2
History of intolerance to ADC therapy composed of monomethyl auristatin E (MMAE).
Inadequate washout period of prior antitumor therapy prior to the first dose
Patients who have undergone major surgery (excluding diagnostic surgery) within 4 weeks prior to first dose or those who plan to undergo major surgery during the study period. Interventional or ablative procedures for tumor treatment within 2 weeks prior to the first dose of the investigational drug.
Previous allogeneic bone marrow transplantation or previous solid organ transplantation.
Sequential
KY-0301
DrugKY-0301 is an antibody-drug conjugate (ADC) targeting both EGFR and c-Met, developed independently by Novatim Immune Therapeutics (Zhejiang) Co., Ltd
Occurrence of dose-limiting toxicity (DLT)
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
MTD
The maximum tolerated dose (MTD) is defined as the maximum dose where the number of cases of DLT ≤ 1/6 of the total number of cases during the DLT observation period. At least 6 evaluable subjects are required to determine MTD.
The area under curve (AUC) of KY-0301 (ADC) in plasma
Area under the plasma concentration versus time curve
The immunogenicity of KY-0301
Occurrence of anti-drug antibodies (ADA)
Objective response rate (ORR)
defined as percentage of participants with confirmed best overall response of confirmed partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Progression-free survival (PFS)
PFS is defined as time from first study treatment to a documented disease progression according to RECIST, version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.
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