KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor

NCT04040699 | Completed Phase 1 DMC

• 1 other identifier: KN046-IST-02
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase Ib, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN026 combined with KN046 in subjects with advanced HER2 positive solid tumors.

Conditions

HER2 Positive Solid Tumor

Keywords

KN026; KN046; HER2 Positive Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity（DLT）

  Dose-limiting toxicity

  28 days

• Objective response rate (ORR)

  Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment

  up to 2 years

• Duration of response (DOR)

  Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment

  up to 2 years

Secondary Outcomes (3)

• Clinical benefit rate

  up to 2 years

• Progression free survival (PFS) rates

  6 months and 12 months

• Overall survival (OS) rates

  6 months and 12 months

Study Arms (1)

KN026 combined with KN046

EXPERIMENTAL

KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade. KN046 is a PD-L1 - CTLA-4 bispecific antibody.

Biological: KN026 combined with KN046

Interventions

KN026 combined with KN046 BIOLOGICAL

KN026 and KN046 are given at 20mg/Kg and 3mg/Kg intravenously on day 1of each 2 weeks cycle at the beginning respectively.The dosage will be escalated if adverse events are tolerated according to the scheme.

KN026 combined with KN046

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed inform consent form (ICF)
• Age ≥ 18 years and ≤ 75 years, male or female
• Histologically or cytologically documented advanced HER2 positive solid tumor
• Received at least one prior standard therapy
• At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function
• LVEF≥ 50% (ECHO)
• Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
• Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures

You may not qualify if:

• Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
• Accepted radiotherapy within 4 weeks before enrollment
• An anthracyclines antibiotic treatment was received exceeding 320 mg/m² or other equivalent dose antharcyclines
• Subjects are eligible with clinically controlled and stable neurologic function \>= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
• Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to \< 10 mg prednisone daily, inhaled steroids and topical use of steroids)
• Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines)
• Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study
• Severe chronic and active infection, need to system antibiosis/antiviral treatment
• Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management
• Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage

Sponsors & Collaborators

• Peking University: lead
• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Study Officials

• Lin Shen, MD,PhD

  Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,Professor,Chief of Department of GI Oncology,Peking University Cancer Hospital

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 1, 2019
• Study Start: September 26, 2019
• Primary Completion: September 22, 2022
• Study Completion: December 1, 2023
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)