A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor
- Registration Number
- NCT04162327
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
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Written (signed) informed consent.
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Life expectancy ≥12 weeks.
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Patients with HER2-expressing advanced solid tumor who failed on current standard of care
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According to RECIST 1.1, at least one measurable lesion (radiation-naïve) exists.
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ECOG performance status 0-1.
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Adequate organ and marrow function evaluated by laboratory tests as follow:
- CBC: absolute neutrophil count (ANC) ≥ 1.0×109/L (Ia stage) or 1.5×109/L (Ib stage); Platelet (PLT) ≥ 75×109/L; Hemoglobin (HGB) ≥ 9.0g/L;
- Liver function: Total bilirubin (TBIL) ≤ 1.5×upper limit of normal value (ULN) for patients without hepatic metastases, ≤ 2×ULN for patients with hepatic metastases or Gilbert syndrome; Alanine aminotransferase (ALT) ≤ 2.5×ULN; Aspartate transferase (AST) ≤ 2.5×ULN;
- Renal function: Clearance of creatinine (CCr) by Cockcroft-Gault formula or 24-hour urine collection ≥ 50ml/min;
- Urinalysis: urine protein < 2+ or urine protein in 24-hour urine collection < 1g;
- Coagulation function: activated partial thromboplastin time (APTT）≤ 1.5×ULN; international normalized ratio (INR）≤ 1.5
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left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography;
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Accumulative exposure to doxorubicin ≤ 360mg/m2; accumulative exposure to epirubicin ≤ 720mg/m2;
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Agree to use an approved contraceptive method during the treatment period, until 180 days after last dose of treatment.
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Post-menopause female subject or pre-menopause female with negative HCG level in urine or blood.
- Any greater than NCI CTCAE 0/1 adverse event exists within 4 weeks before enrollment, not including hair loss and fatigue;
- Received major surgery or having unhealed wound, ulcer, or bone fracture;• Received whole pelvic radiation;
- Plan to receive any other anti-cancer therapy not specified in the protocol, except for palliative radiotherapy;
- CNS metastasis, spinal compression, or carcinomatous meningitis
- Active autoimmune disease or inflammatory disorders.
- Primary immunodeficiency diseases;
- Pregnant or breast-feeding female.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ia stage - IBI315 Dose escalation IBI315 - Ib stage - IBI315 monotherapy IBI315 -
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve (AUC) up to 9 months Maximum plasma concentration (Cmax) up to 9 months Terminal elimination half-life (T1/2) up to 9 months Apparent volume of distribution (Vd) up to 9 months
- Secondary Outcome Measures
Name Time Method Evaluate receptor occupancy (RO) following single-dose or multi-dose of IBI315 up to 9 months The percentage of participants with anti-drug antibody (ADA) positive after dosing IBI315 up to 9 months The percentage of participants with neutralizing antibody (NAb) positive after dosing IBI315 up to 9 months
Trial Locations
- Locations (1)
The 307th Hospital of Chinese People's Liberation Army
🇨🇳Beijing, China