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

Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country55 target enrollmentNovember 26, 2019

ConditionsAdvanced Solid Tumor

InterventionsIBI315

DrugsIBI315

Overview

Phase: Phase 1
Intervention: IBI315
Conditions: Advanced Solid Tumor
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Enrollment: 55
Locations: 1
Primary Endpoint: Area under the plasma concentration-time curve (AUC)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 26, 2019

End Date

June 20, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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-
•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;

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.

Arms & Interventions

Ia stage - IBI315 Dose escalation

Intervention: IBI315

Ib stage - IBI315 monotherapy

Intervention: IBI315

Outcomes

Primary Outcomes

Area under the plasma concentration-time curve (AUC)

Time Frame: up to 9 months

Maximum plasma concentration (Cmax)

Time Frame: up to 9 months

Terminal elimination half-life (T1/2)

Time Frame: up to 9 months

Apparent volume of distribution (Vd)

Time Frame: up to 9 months

Secondary Outcomes

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)