A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor

Innovent Biologics

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumor

Treatments

Drug: IBI315

Study type

Interventional

Funder types

Industry

Identifiers

NCT04162327

CIBI315A101

Details and patient eligibility

About

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

Full 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.

Enrollment

55 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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:
- 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
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

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.