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KN046 in Subjects With Advanced Solid Tumors and Lymphoma

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ClinicalTrials.gov Identifier: NCT03733951
Recruitment Status : Not yet recruiting
First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Brief Summary:
This is a phase Ia/Ib, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN046 in subjects with advanced solid tumors and lymphoma .

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Lymphoma Drug: KN046 Phase 1

Study Type : Interventional
Estimated Enrollment : 285 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Dose-Escalation and Expansion Phase Ia/Ib Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KN046 Monotherapy in Subjects With Advanced Solid Tumors and Lymphoma
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: KN046 Drug: KN046

Phase Ia:Intravenous (IV) infusions, 1,3 and 5 milligrams per kilogram (mg/kg) every 2 weeks.

Phase Ib:Intravenous (IV) infusions, 1 ,3 or 3, 5 milligrams per kilogram (mg/kg) every 2 weeks, the dose of phase Ib based on the result of phase Ia.





Primary Outcome Measures :
  1. In the dose escalation part, number of participants with dose limiting toxicity (DLT). [ Time Frame: During the first 4 weeks of treatment. ]
  2. In the dose expansion part,Objective response rate (ORR). [ Time Frame: up to 2 years. ]
  3. In the dose expansion part, Duration of response (DoR). [ Time Frame: up to 2 years. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent; willing and able to complete all required procedures of study.
  2. With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
  3. Subjects must have at least one measurable lesion in advanced solid tumors, at least one measurable or assessable lesion in NK/T cell lymphoma.
  4. ECOG performance status of 0 or 1.
  5. Subject must have adequate organ function.
  6. 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.
  7. Ability to comply with treatment, procedures and PK sample collection and the required study follow-up procedures.

Exclusion Criteria:

  1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
  2. Is currently participating or has participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment.
  3. Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
  4. Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
  5. Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
  6. Active HBV or HCV infection.
  7. Known HIV infection or known history of acquired immune deficient syndrome (AIDS).
  8. Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
  9. Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733951


Locations
China, Guangdong
Sun Yat-sen University Cancer Center Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Li Zhang, M.D.       zhangli6@mail.sysu.edu.cn   
Principal Investigator: Li Zhang, M.D.         
Sponsors and Collaborators
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Responsible Party: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
ClinicalTrials.gov Identifier: NCT03733951     History of Changes
Other Study ID Numbers: KN046-CHN-001
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

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

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases