This is a Phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the RP2D of sequential doses of IBI354 (study drug), and to explore and confirm the efficacy, safety and tolerability of IBI354 in subjects with locally advanced unresectable or metastatic solid tumors.
Male or female subjects, ≥ 18 years
Phase 1a : Has a pathologically documented advanced/unresectable or metastatic solid tumor with HER2 alterations (IHC 1+, IHC 2+, IHC 3+ and/or ISH+ and/or NGS confirmed mutant or amplification).
Adequate bone marrow and organ function
Subjects, both male and female, who are either not of childbearing potential or who agree to use at least one highly effective method of contraception during the study (begin from screening or within 2 weeks prior to the first dose, whichever comes first, and continue until 6 months after the last dose of study drug); Subjects, both male and female, who are either not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within 2 weeks prior to the first dose and continuing until 6 months after the last dose of study drug
Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter;
Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study;
Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives (whichever is longer) before first administration of the study drug.
Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigators' opinion) or baseline prior to first administration of the study drug;
Single group
IBI354
Biological/VaccineRecombinant Anti-HER2 monoclonal Antibody-Camptothecin derivative conjugate for injection
Incidence of serious adverse events (SAEs), treatment-emergent AEs (TEAEs).
An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. A TEAE will be defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered.
Number of dose-limiting toxicity (DLT)
Incidence of dose-limiting toxicity (DLT) events.
Objective response rate (ORR)
ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR).
duration of response (DoR)
DoR is defined as the time from the date of first documented tumor response (CR/PR) until PD/death.
progression-free survival (PFS)
PFS is defined as the time from the date of first dose of study drug to the date of the first documented progression or death due to any cause, whichever occurs first.
Overall survival (OS)
OS is defined as the time from the date of first dose of study drug until the date of death from any cause.
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