Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma
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
3 other identifiers
interventional
98
2 countries
21
Brief Summary
The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2019
Typical duration for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2019
CompletedFirst Submitted
Initial submission to the registry
April 26, 2019
CompletedFirst Posted
Study publicly available on registry
May 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2023
CompletedJuly 1, 2024
June 1, 2024
3.7 years
April 26, 2019
June 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Dose Limiting Toxicities (DLT)
Part 1A DLT period is 3 weeks, Part 1B DLT period is 3 weeks, Part 1C DLT period is 4 weeks.
21 or 28 days, depending on study part
Incidence and Severity of Adverse Events
The CTCAE criteria will be used to assess adverse events on this trial.
up to 100 days post last dose
Maximum Tolerated Dose (MTD) for Both Monotherapy and Combination Therapy
Based on DLT definitions.
21 or 28 days, depending on study part
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status.
up to 100 days post last dose
Secondary Outcomes (16)
Pharmacokinetic (PK): Area Under the Curve From Time Zero To Infinity (AUC∞)
up to 100 days post last dose
PK: Area Under the Curve From Time Zero To The Time Of The Last Quantifiable Concentration (AUC0-t)
up to 100 days post last dose
PK: Maximum Observed Concentration (Cmax)
up to 100 days post last dose
PK: Time of the Maximum Observed Concentration (Tmax)
up to 100 days post last dose
PK: Terminal Elimination Half-Life (T1/2)
up to 100 days post last dose
- +11 more secondary outcomes
Study Arms (4)
Part 1A - TJ011133 Monotherapy
EXPERIMENTALTJ011133 alone will be administered at up to 7 dose levels (0.3, 1, 3, 10, 20, 30, 45 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).
Part 1B - Combination therapy of TJ011133 with pembrolizumab
EXPERIMENTALTJ011133 will be administered Q1W, starting at 20 mg/ kg, in combination with pembrolizumab.
Part 1C - Combination therapy of TJ011133 with rituximab
EXPERIMENTALTJ011133 will be administered Q1W, starting at 20 mg/kg, in combination with rituximab.
Part 2 - Dose Expansion
EXPERIMENTAL30 participants (with DLBCL or indolent lymphoma) in the TJ011133 combination therapy with rituximab expansion and 20 participants with solid tumors in the TJ011133 combination therapy with pembrolizumab expansion.
Interventions
TJ011133 will be administered weekly.
Pembrolizumab will be administered every 3 weeks.
Rituximab will be administered weekly for 5 doses, then followed by monthly doses.
Eligibility Criteria
You may qualify if:
- Part 1: Participants with advanced relapsed/refractory solid tumors and lymphoma.
- Part 2 with Rituximab: Participants with diffuse large B-cell lymphoma (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: Participants with locally advanced non-small-cell lung carcinoma (NSCLC) with disease progression or immune-oncology treatment naive Epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with at least one measurable lesion defined by Response Elevation Criteria in Solid Tumors (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.
You may not qualify if:
- Participants with known symptomatic central nervous system tumors or known central nervous system metastases or leptomeningeal disease requiring steroids. Participants who document stable and central nervous system metastases and are off steroids for more than 4 weeks may be enrolled in the study.
- Participants with Burkitt's lymphoma, lymphoblastic lymphoma, Richter's transformation, primary effusion lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma.
- Participants 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- I-Mab Biopharma US Limitedlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (21)
University of Alabama - Birmingham
Birmingham, Alabama, 35233, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Yale School of Medicine
New Haven, Connecticut, 06510, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Horizon Oncology
Lafayette, Indiana, 47905, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Cancer Institute/Henry Ford Hospital
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
NYU Langone Health
New York, New York, 10016, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
The Fourth Hpspital of Hebei Medical University(Hebei Cancer Hospital)
Shijiazhuang, Hebei, 50011, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
HuBei Cancer Hospital
Wuhan, Hubei, 430000, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2019
First Posted
May 2, 2019
Study Start
April 16, 2019
Primary Completion
January 10, 2023
Study Completion
January 10, 2023
Last Updated
July 1, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share