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

NCT ID: NCT04162327

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-26
• Study Completion Date: 2023-06-20

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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ia stage - IBI315 Dose escalation

Group Type: EXPERIMENTAL

IBI315

Intervention Type: DRUG

Patients will receive IBI315 until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue.

Ib stage - IBI315 monotherapy

Group Type: EXPERIMENTAL

IBI315

Intervention Type: DRUG

Patients will receive IBI315 RP2D until disease progression,intolerability, informed consent withdraw, or otherreasons leading to treatment discontinue.

Interventions

IBI315

Patients will receive IBI315 until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue.

Intervention Type: DRUG

IBI315

Patients will receive IBI315 RP2D until disease progression,intolerability, informed consent withdraw, or otherreasons leading to treatment discontinue.

Intervention Type: DRUG

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 0-1.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The 307th Hospital of Chinese People's Liberation Army

Beijing, , China

Countries

China

Other Identifiers

CIBI315A101

Identifier Type: -

Identifier Source: org_study_id