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Study of TJ011133 Subjects With Relapsed/Refractory Advanced Solid Tumors and Lymphoma

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ClinicalTrials.gov Identifier: NCT03934814
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
I-Mab Biopharma Co. Ltd.

Brief Summary:
The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.

Condition or disease Intervention/treatment Phase
Solid Tumor Lymphoma Drug: TJ011133 Drug: Pembrolizumab Drug: Rituximab Phase 1

Detailed Description:
This is an open-label, multi-center, multiple dose, Phase 1 study to evaluate the safety, tolerability, maximum tolerated dose (MTD) or maximum administered dose (MAD), pharmacokinetic (PK), pharmacodynamic, and recommended Phase 2 dose (RP2D) of TJ011133, an anti-CD47 antibody, in subjects with advanced relapsed or refractory solid tumors and lymphoma. The study will be conducted in 2 parts. Part 1 comprises a single agent dose escalation (Part 1A) and 2 separate combination therapy dose escalations (Part 1B with pembrolizumab and Part 1C with rituximab) and Part 2 includes a dose expansion study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of TJ011133 Administered Alone or in Combination With Pembrolizumab or Rituximab in Subjects With Relapsed/Refractory Advanced Solid Tumors and Lymphoma
Actual Study Start Date : May 8, 2019
Estimated Primary Completion Date : February 21, 2022
Estimated Study Completion Date : September 23, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Part 1A - TJ011133 Monotherapy
TJ011133 alone will be administered at up to 6 dose levels (0.3, 1, 3, 10, 20, or 30 mg/kg) once weekly (Q1W) (the 0.3 mg/kg dose level cohort will be enrolled if a DLT in 1 out of 3 subjects is observed following the 1 mg/kg dose level)
Drug: TJ011133
TJ011133 will be administered weekly

Experimental: Part 1B - Combination therapy of TJ011133 with pembrolizumab
TJ011133 will be administered Q1W, starting at one dose level below MTD or MAD in monotherapy arm, in combination with pembrolizumab
Drug: TJ011133
TJ011133 will be administered weekly

Drug: Pembrolizumab
Pembrolizumab will be administered every 3 weeks
Other Name: Keytruda

Experimental: Part 1C -Combination therapy of TJ011133 with rituximab
TJ011133 will be administered Q1W, starting at one dose level below MTD or MAD in monotherapy arm, in combination with rituximab
Drug: TJ011133
TJ011133 will be administered weekly

Drug: Rituximab
Rituximab will be administered weekly for 5 doses, then followed by monthly doses
Other Name: Rituxan, MabThera

Experimental: Part 2 - Dose Expansion
20 subjects (with DLBCL or indolent lymphoma) in the TJ011133 combination therapy with rituximab expansion and 20 subjects with solid tumors in the TJ011133 combination therapy with pembrolizumab expansion.
Drug: TJ011133
TJ011133 will be administered weekly

Drug: Pembrolizumab
Pembrolizumab will be administered every 3 weeks
Other Name: Keytruda

Drug: Rituximab
Rituximab will be administered weekly for 5 doses, then followed by monthly doses
Other Name: Rituxan, MabThera




Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLT) [ Time Frame: 21 or 28 days, depending on Study Part ]
    Part 1A DLT period is 3 weeks, Part 1B DLT period is 3 weeks, Part 1C DLT period is 4 weeks

  2. Incidence and Severity of Adverse Events [ Time Frame: up to 100 days post last dose ]
    The CTCAE criteria will be used to assess adverse events on this trial.

  3. Maximum Tolerated Dose (MTD) for both monotherapy and combination therapy [ Time Frame: 21 or 28 days, depending on Study Part ]
    Based on DLT Definitions


Secondary Outcome Measures :
  1. Pharmacokinetic Parameters: Tmax [ Time Frame: up to 100 days post last dose ]
    Time of peak concentration (Tmax)

  2. Pharmacokinetic Parameters: Cmax [ Time Frame: up to 100 days post last dose ]
    Maximal concentration (Cmax)

  3. Pharmacokinetic Parameters: T1/2 [ Time Frame: up to 100 days post last dose ]
    Investigational Product (IP) half-life (T1/2)

  4. Pharmacokinetic Parameters: CL [ Time Frame: up to 100 days post last dose ]
    Investigational Product (IP) Clearance (CL)

  5. Pharmacokinetic (PK) Parameters: AUC∞ [ Time Frame: up to 100 days post last dose ]
    Area under the curve from time zero extrapolated to infinity (AUC∞)

  6. Anti-drug antibodies (ADA) [ Time Frame: up to 100 days post last dose ]
    Incidence and concentration of anti-drug antibodies



Information from the National Library of Medicine

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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:

  • Part 1: Subjects with advanced relapsed/refractory solid tumors and lymphoma
  • Part 2 with Rituximab: Subjects with DLBCL or Indolent B-cell Lymphoma, with at least one measurable lesion by Lugano and available fresh metastatic biopsy sample prior to study entry.
  • Part 2 with Pembrolizumab: Subject with locally advanced non-small-cell lung carcinoma (NSCLC) with disease progression, Urothelial (bladder) cancer that is not eligible for cisplatin-containing chemotherapy or has progressed following cisplatin-containing chemotherapy, or immune-oncology treatment naive Epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with at least one measurable lesion defined by RECIST 1.1, and available fresh metastatic biopsy prior to study entry.
  • All Parts: Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 and adequate bone marrow, renal, and liver functions.

Exclusion Criteria:

  • Subjects with known symptomatic central nervous system tumors or known central nervous system metastases or leptomeningeal disease requiring steroids. Subjects who document stable and central nervous system metastases and are off steroids for more than 4 weeks may be enrolled in the study
  • Subjects with Burkitt's lymphoma, lymphoblastic lymphoma, Richter's transformation, primary effusion lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma
  • Subjects with mantle cell lymphoma
  • Impaired cardiac function or clinically significant cardiac diseases
  • Prior treatment with CD47 or SIRPα inhibitors
  • Prior autologous stem cell transplant ≤3 months prior to starting study
  • Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning
  • Prior chimeric antigen receptor or chimeric antigen receptor T-cell therapy
  • History of autoimmune anemia or autoimmune thrombocytopenia
  • Positive Direct Antiglobulin Test
  • Active graft versus host disease (GVHD) or ongoing immunosuppression for GVHD

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): NCT03934814


Contacts
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Contact: US Site Head 301-294-4408 us.info@i-mabbiopharma.com

Locations
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United States, Alabama
University of Alabama - Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35233
Principal Investigator: Amitkumar N Mehta, M.D.         
United States, Arizona
Mayo Clinic Not yet recruiting
Scottsdale, Arizona, United States, 85259
Principal Investigator: Mahesh Seetharam, M.D.         
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Principal Investigator: Yan Xing, MD, PhD         
United States, Connecticut
Yale School of Medicine Not yet recruiting
New Haven, Connecticut, United States, 06510
Principal Investigator: Iris Isufi, M.D.         
United States, Florida
Mayo Clinic Not yet recruiting
Jacksonville, Florida, United States, 32224
Principal Investigator: Winston W Tan, M.D.         
United States, Indiana
Horizon Oncology Recruiting
Lafayette, Indiana, United States, 47905
Contact: Elizabeth Morris    765-446-5111    eamorris@horizonbioadvance.com   
Principal Investigator: Wael A Harb, MD         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Shirish Gadgeel, MD         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Alex A Adjei, M.D., PhD.         
United States, New York
NYU Langone Health Not yet recruiting
New York, New York, United States, 10016
Principal Investigator: Catherine M Diefenbach, M.D.         
United States, Tennessee
Vanderbilt-Ingram Cancer Center Not yet recruiting
Nashville, Tennessee, United States, 37203
Contact: Clinical Trials Information Program    800-811-8480      
Principal Investigator: Jordan Berlin, MD         
United States, Washington
Seattle Cancer Care Alliance Not yet recruiting
Seattle, Washington, United States, 98109
Principal Investigator: Ajay K Gopal, M.D.         
Sponsors and Collaborators
I-Mab Biopharma Co. Ltd.
Investigators
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Study Director: Claire Xu, MD, PhD I-Mab Biopharma

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Responsible Party: I-Mab Biopharma Co. Ltd.
ClinicalTrials.gov Identifier: NCT03934814     History of Changes
Other Study ID Numbers: TJ011133EDI101
KN-A21 ( Other Identifier: Merck )
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents