This study is an open-label, first-in-human Phase I clinical study to evaluate the safety, tolerability, PK characteristics, and preliminary antitumor activity of HLX316 in participants with advanced/metastatic solid tumors. The study will consist of 2 parts: a Phase Ia dose-escalation part and a Phase Ib dose-expansion part. Phase Ia and Phase Ib will focus on exploring the preliminary antitumor activity of HLX316 in participants with platinum-resistant ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Fully understand the contents, process and possible adverse reactions of the study before the study, sign the informed consent form, voluntarily participate in the study, and be able to complete the study according to the requirements of the study protocol;
Aged ≥ 18 years at the time of signing ICF;
Participants with histologically or cytologically confirmed advanced or metastatic solid tumors who have failed at least one line of standard systemic therapy in the advanced or metastatic setting (participants who received neoadjuvant or adjuvant therapy and experienced progressive disease or relapse within 6 months after completion of such therapy will be considered to have failed one line of standard therapy), or for whom no effective standard therapy is available, or who are intolerant of or refuse standard systemic therapy;
At least 1 measurable lesion per RECIST v1.1 within 4 weeks prior to the first dose; for participants who have received prior radiotherapy, a previously irradiated lesion may be considered a target lesion if it is measurable per RECIST v1.1 and there is objective evidence of significant progression following radiotherapy; brain metastatic lesions may not serve as target lesions;
History of arterial thromboembolic events, stroke, or transient ischemic attack within the past 12 months.
History of symptomatic chronic heart failure (New York Heart Association [NYHA] Class II-IV or left ventricular ejection fraction [LVEF] < 50%) or history of arrhythmia requiring treatment (including QTc interval ≥ 450 ms in males or ≥ 470 ms in females) (QTc interval calculated using the Fridericia formula).
History of myocardial infarction or unstable angina within 6 months prior to the first dose of HLX316.
Evidence of active infection requiring intravenous antibiotic therapy during the screening period, or evidence of active infection requiring treatment within 7 days prior to the first dose of HLX316.
Single group
HLX316
DrugParticipants will receive HLX316 administered by intravenous infusion on D 1 of each cycle, with a cycle length of 1 week.
The proportion of participants within each dose cohort who experience dose-limiting toxicity (DLT) events during the DLT evaluation period
To determine the maximum tolerated dose (MTD) of HLX316
RP2D
The recommended phase 2 dose of HLX316
Objective response rate (ORR)
Percentage of participants with complete response (CR) and partial response (PR) based on investigator assessment.
AE
The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 6.0
PK
maximum concentration (Cmax)
PK
time to maximum concentration (Tmax)
PK
elimination half-life (t1/2)
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