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Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT03474640
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : March 26, 2018
Sponsor:
Collaborators:
TopAlliance Biosciences, Inc.
Novella Clinical
Information provided by (Responsible Party):
Shanghai Junshi Bioscience Co.,Ltd.

Brief Summary:

The primary objective is to assess the safety and tolerability of TAB001 in subjects with various advanced malignancies and to evaluate the recommended Phase 2 dose.

The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of TAB001, 2) evaluate antitumor activity of TAB001; 3) determine the immunogenicity of TAB001 , and 4) evaluate pharmacodynamic effects of TAB001 on its target receptor, programmed cell death 1 (PD-1), as well as effects on the immune system.

The exploratory objectives are to: 1) evaluate biomarkers that may correlate with activity of TAB001, 2) evaluate the utility of PD-L1 & additional exploratory markers as biomarkers that could aid in selection of appropriate subjects for TAB001 therapy, and 3) identification of additional biomarkers correlating with response to treatment with TAB001.


Condition or disease Intervention/treatment Phase
Advanced Malignancies Biological: TAB001, Recombinant Humanized anti-PD-1 Monoclonal Antibody Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAB001 in Subjects With Advanced Malignancies
Actual Study Start Date : March 14, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
Experimental: TAB001 80 mg repeat dose every 14 days
3-6 subjects
Biological: TAB001, Recombinant Humanized anti-PD-1 Monoclonal Antibody
TAB001 is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
Other Name: JS001

Experimental: TAB001 240 mg repeat dose every 14 days
3-6 subjects
Biological: TAB001, Recombinant Humanized anti-PD-1 Monoclonal Antibody
TAB001 is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
Other Name: JS001

Experimental: TAB001 480 mg repeat dose every 14 days
3-6 subjects
Biological: TAB001, Recombinant Humanized anti-PD-1 Monoclonal Antibody
TAB001 is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
Other Name: JS001




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Through Day 90 of last dose ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Every 8 weeks through study completion, an average of 1 year ]
    The treatment effect of TAB001 will be assessed using RECIST 1.1 to determine objective response rate.

  2. Disease Control Rate (DCR) [ Time Frame: Every 8 weeks through study completion, an average of 1 year ]
    The treatment effect of TAB001 will be assessed using RECIST 1.1 to determine disease control rate.

  3. Progression-Free survival (PFS) [ Time Frame: Every 8 weeks through study completion, an average of 1 year ]
    The treatment effect of TAB001 will be assessed using RECIST 1.1 to determine progression-free survival time.



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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. Willing to sign Informed Consent;
  • 2. Part A, must have a histologically or cytologically documented, incurable, or metastatic solid tumor that has progressed on, or been intolerant to, all standard systemic therapy options for the tumor type in the metastatic setting, or must have a tumor type for which no such standard systemic option exists;
  • 3. Part B, must have a histologically or cytologically documented diagnosis of esophageal or gastric carcinoma, nasopharyngeal carcinoma (NPC), endometrial cancer, soft tissue sarcoma, or other orphan tumor who have received at least one line of standard systemic therapy for their respective tumor type in the metastatic setting with progressive locally advanced or metastatic disease that is not amenable to definitive local therapy with curative intent;

    1. Subjects with NPC must have received, or been intolerant to, a platinum-based combination as part of their prior therapy for advanced/metastatic disease;
    2. Subjects with soft tissue sarcoma must have radiographic evidence of progression within the previous 3-4 months and must have received, or been intolerant to, prior treatment with an anthracycline +/- olaratumab or ifosfamide;
    3. Patients with esophageal cancer must have received, or been intolerant to, a platinum-based combination as part of their prior therapy for advanced/metastatic disease;
    4. Patients with gastric cancer must have received, or been intolerant to, a fluoropyrimidine-platinum combination as part of their prior therapy for advanced/metastatic disease; Subjects in Part B must not have had more than 3 prior lines of cytotoxic chemotherapy;
  • 4. Measurable disease per RECIST v1.1 and irRECIST;
  • 5. ECOG performance status of 0 or 1;
  • 6. Adequate organ and marrow function;
  • 7. Willingness to provide consent for biopsy samples;
  • 8. For females of childbearing potential, use effective contraception from time of screening though 90 days post last dose of TAB001.

Exclusion Criteria:

  • 1. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study;
  • 2. Any concurrent chemotherapy, radiotherapy, immunotherapy, or biologic therapy for cancer treatment. Concurrent use of hormones for non-cancer related conditions is acceptable (e.g., insulin for diabetes & hormone replacement therapy). Local treatment of isolated lesions for palliative intent is acceptable;
  • 3. Receipt of any investigational anti-cancer therapy within 4 weeks prior to first dose of TAB001;
  • 4. Receipt of G-CSF, GM-CSF or erythropoietin within 28 days prior to study entry or receiving TAB001;
  • 5. Current use or prior use of immunosuppressive medication within 4 weeks prior to first dose of TAB001, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids not to exceed 10mg/day of prednisone or equivalent;
  • 6. Part A: Prior exposure to immunotherapy such as but not limited to other anti-CTLA-4, anti-PD-1, or anti-PD-L1 antibodies excluding vaccines. Part B: Exclusion of prior immunotherapy exposure will be limited to anti-PD-1, anti-PD-L1, or anti-PD-L2;
  • 7. Prior allogeneic bone marrow transplantation or prior solid organ transplantation;
  • 8. Major surgery within 4 weeks prior to first dose of TAB001 or still recovering from prior surgery;
  • 9. Unresolved toxicities from prior anticancer therapy defined as having not resolved to baseline or to Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia;
  • 10. Active or prior documented autoimmune disease within the past 2 years. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded;
  • 11. Known history of tuberculosis;
  • 12. Known to be human immunodeficiency virus (HIV) positive, hepatitis B, or hepatitis C positive;
  • 13. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis);
  • 14. History of primary immunodeficiency;
  • 15. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure according to NYHA Functional Classification ≥3, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events from TAB001, or compromise the ability of the subject to give written informed consent;
  • 16. Symptomatic or untreated central nervous system metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 8 weeks prior to study entry, have no evidence of new or enlarging metastases, and are off steroids;
  • 17. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving TAB001;
  • 18. Pregnancy or breastfeeding women.

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): NCT03474640


Contacts
Contact: Michael Armstrong, MD, PhD 919-373-2522 Michael.Armstrong@novellaclinical.com
Contact: Stanley Pillemer, MD 301-512-4172 pillemers@americanbiopharma.com

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Lauren Dabdoub    720-848-1156    lauren.dabdoub@ucdenver.edu   
Principal Investigator: Victor Villalobos, PhD, MD         
United States, North Carolina
Carolina BioOncology Institute Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Danielle Bodziony    704-947-6599 ext 130    dbodziony@carolinabiooncology.org   
Principal Investigator: John Powderly, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Sheetal Champaneria    615-329-6875    sheetal.champaneria@scresearch.net   
Principal Investigator: Todd Bauer, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Carolina Corkill    713-792-1149    cocorkill@mdanderson.org   
Principal Investigator: Aung Naing, MD         
Sponsors and Collaborators
Shanghai Junshi Bioscience Co.,Ltd.
TopAlliance Biosciences, Inc.
Novella Clinical
Investigators
Study Director: Sheng Yao, PhD TopAlliance Biosciences, Inc.

Responsible Party: Shanghai Junshi Bioscience Co.,Ltd.
ClinicalTrials.gov Identifier: NCT03474640     History of Changes
Other Study ID Numbers: TAB001-01
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018

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

Keywords provided by Shanghai Junshi Bioscience Co.,Ltd.:
immunotherapy
check point inhibitor
PD-1 antibody
solid tumor
esophageal carcinoma
gastric carcinoma
nasopharyngeal carcinoma
endometrial cancer
soft tissue sarcoma
orphan tumors
phase 1 trial

Additional relevant MeSH terms:
Neoplasms
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs