A Phase Ia/Ib, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI315, an Anti-HER2/PD-1 Bi-specific Antibody in Patients With HER2-expressing Advanced Solid Tumor
A Phase Ia/Ib, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI315, an Anti-HER2/PD-1 Bi-specific Antibody in Patients With HER2-expressing Advanced Solid Tumor
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI315, a HER2/PD-1 bi-specific antibody in patients with advanced solid tumors
This phase Ia/Ib, open-label, multicenter study has two stages. The Ia stage is a dose-escalation study that will focus on safety, tolerability, efficacy and RP2D . Patients with HER2-expressing advanced solid tumor who failed from previous standard of care will be enrolled in the phase Ia study. DLT observation period is 28 days.
Inclusion Criteria:
Written (signed) informed consent.
Life expectancy ≥12 weeks.
Patients with HER2-expressing advanced solid tumor who failed on current standard of care
According to RECIST 1.1, at least one measurable lesion (radiation-naïve) exists.
ECOG performance status 0-1.
Adequate organ and marrow function evaluated by laboratory tests as follow:
left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography;
Accumulative exposure to doxorubicin ≤ 360mg/m2; accumulative exposure to epirubicin ≤ 720mg/m2;
Agree to use an approved contraceptive method during the treatment period, until 180 days after last dose of treatment.
Post-menopause female subject or pre-menopause female with negative HCG level in urine or blood.
Exclusion Criteria: