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KN046 (a Humanized PD-L1/CTLA4 Bispecific Single Domain Fc Fusion Protein Antibody) in Subjects With Thymic Carcinoma

Primary Purpose

Thymic Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
KN046
Sponsored by
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thymic Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Male or female, ≥18 years
  • Pathologically confirmed diagnosis of thymic carcinoma
  • Inoperable or metastatic disease
  • Had failed at least one regimen containing platinum-based combination chemotherapy for locally advanced unresectable or metastatic disease
  • Baseline measurable disease

Exclusion Criteria

  • Thymomas, thymolipoma, germ cell tumors, teratomas, seminomas
  • Leptomeningeal metastasis or untreated active CNS (central nervous system) metastasis or leptomeningeal metastasis.
  • Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks
  • Has received other anti-tumor treatment within 4 weeks
  • Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment
  • Curative radiation within 3 months of the first dose of trial treatment.
  • Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment

Sites / Locations

  • Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Thymic carcinoma

Arm Description

enrolled subjects will receive KN046 every 2 weeks.

Outcomes

Primary Outcome Measures

ORR
ORR (best overall response) per RECIST v1.1 calculated as the proportion of subjects with a best overall response defined as confirmed complete response or confirmed partial response (CR+PR) by Independent Review Committee;

Secondary Outcome Measures

DOR
DOR (duration of response), calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer;
DCR
DCR (disease control rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD (stable disease);
CBR
CBR (clinical benefit rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD on at least 24 weeks;
PFS
PFS (progression free survival), defined as time from first dose of trial treatment to progression or death due to any cause;
TTR
TTR (time to response), calculated as the time from first dose of trial treatment to first documented response (CR+PR);

Full Information

First Posted
July 7, 2020
Last Updated
April 3, 2023
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04469725
Brief Title
KN046 (a Humanized PD-L1/CTLA4 Bispecific Single Domain Fc Fusion Protein Antibody) in Subjects With Thymic Carcinoma
Official Title
A Phase 2, Open-Label, Multi-Center Study to Evaluate Efficacy, Safety and Tolerability of KN046 in Subjects With Thymic Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a Phase 2, open-label, multi-center, single arm study in subjects with advanced thymic carcinoma after failure of platinum-based combination chemotherapy. Subjects should have documented progressive disease while on platinum-based combination chemotherapy. If subjects discontinued platinum-based therapy due to reasons other than progressive disease, subjects should have completed at least 2 cycles of platinum-based combination chemotherapy before the commencement of documented progressive disease. Subjects will be treated with KN046 5 milligram per kilogram every 2 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymic Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
subjects enrolled receive KN046
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thymic carcinoma
Arm Type
Experimental
Arm Description
enrolled subjects will receive KN046 every 2 weeks.
Intervention Type
Drug
Intervention Name(s)
KN046
Intervention Description
KN046 5 milligram per kilogram, every 2 weeks
Primary Outcome Measure Information:
Title
ORR
Description
ORR (best overall response) per RECIST v1.1 calculated as the proportion of subjects with a best overall response defined as confirmed complete response or confirmed partial response (CR+PR) by Independent Review Committee;
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
DOR
Description
DOR (duration of response), calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer;
Time Frame
up to 3 years
Title
DCR
Description
DCR (disease control rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD (stable disease);
Time Frame
up to 3 years
Title
CBR
Description
CBR (clinical benefit rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD on at least 24 weeks;
Time Frame
up to 3 years
Title
PFS
Description
PFS (progression free survival), defined as time from first dose of trial treatment to progression or death due to any cause;
Time Frame
up to 3 years
Title
TTR
Description
TTR (time to response), calculated as the time from first dose of trial treatment to first documented response (CR+PR);
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Male or female, ≥18 years Pathologically confirmed diagnosis of thymic carcinoma Inoperable or metastatic disease Had failed at least one regimen containing platinum-based combination chemotherapy for locally advanced unresectable or metastatic disease Baseline measurable disease Exclusion Criteria Thymomas, thymolipoma, germ cell tumors, teratomas, seminomas Leptomeningeal metastasis or untreated active CNS (central nervous system) metastasis or leptomeningeal metastasis. Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks Has received other anti-tumor treatment within 4 weeks Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment Curative radiation within 3 months of the first dose of trial treatment. Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhonglin Chen
Phone
86-21-22200000
Ext
3115
Email
chestgcp@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaolong Fu, MD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolong Fu, MD
Phone
86-21-22200000

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34393061
Citation
Remon J, Girard N, Novello S, de Castro J, Bigay-Game L, Bernabe R, Greillier L, Mosquera J, Cousin S, Juan O, Sampayo M, Besse B. PECATI: A Multicentric, Open-Label, Single-Arm Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab and Lenvatinib in Pretreated B3-Thymoma and Thymic Carcinoma Patients. Clin Lung Cancer. 2022 May;23(3):e243-e246. doi: 10.1016/j.cllc.2021.07.008. Epub 2021 Jul 20.
Results Reference
derived

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KN046 (a Humanized PD-L1/CTLA4 Bispecific Single Domain Fc Fusion Protein Antibody) in Subjects With Thymic Carcinoma

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