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

NCT04469725 | Terminated Phase 2

• 1 other identifier: KN046-205
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Thymic Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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;

  up to 2 years

Secondary Outcomes (5)

• DOR

  up to 3 years

• DCR

  up to 3 years

• CBR

  up to 3 years

• PFS

  up to 3 years

• TTR

  up to 3 years

Study Arms (1)

Thymic carcinoma

EXPERIMENTAL

enrolled subjects will receive KN046 every 2 weeks.

Drug: KN046

Interventions

KN046 DRUG

KN046 5 milligram per kilogram, every 2 weeks

Thymic carcinoma

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (1)

• 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.

  PMID: 34393061 DERIVED

MeSH Terms

Conditions

Thymoma

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Xiaolong Fu, MD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: subjects enrolled receive KN046

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 14, 2020
• Study Start: December 2, 2020
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)