Trial record 1 of 1 for:
NCT03934814
Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03934814 |
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Recruitment Status :
Active, not recruiting
First Posted : May 2, 2019
Last Update Posted : August 24, 2022
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Sponsor:
AbbVie
Collaborator:
I-Mab Biopharma Co. Ltd.
Information provided by (Responsible Party):
AbbVie
- Study Details
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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 |
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 participants 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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 98 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 : | April 16, 2019 |
| Estimated Primary Completion Date : | September 15, 2023 |
| Estimated Study Completion Date : | September 15, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part 1A - TJ011133 Monotherapy
TJ011133 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).
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Drug: TJ011133
TJ011133 will be administered weekly. |
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Experimental: Part 1B - Combination therapy of TJ011133 with pembrolizumab
TJ011133 will be administered Q1W, starting at 20 mg/ kg, in combination with pembrolizumab.
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Drug: TJ011133
TJ011133 will be administered weekly. Drug: Pembrolizumab Pembrolizumab will be administered every 3 weeks.
Other Name: Keytruda |
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Experimental: Part 1C - Combination therapy of TJ011133 with rituximab
TJ011133 will be administered Q1W, starting at 20 mg/kg, in combination with rituximab.
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Drug: TJ011133
TJ011133 will be administered weekly. Drug: Rituximab Rituximab will be administered weekly for 5 doses, then followed by monthly doses.
Other Names:
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Experimental: Part 2 - Dose Expansion
30 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.
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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 Names:
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Primary Outcome Measures :
- 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.
- 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.
- Maximum Tolerated Dose (MTD) for Both Monotherapy and Combination Therapy [ Time Frame: 21 or 28 days, depending on study part ]Based on DLT definitions.
- Change in Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: up to 100 days post last dose ]Change in Eastern Cooperative Oncology Group (ECOG) Performance Status.
Secondary Outcome Measures :
- Pharmacokinetic (PK): Area Under the Curve From Time Zero To Infinity (AUC∞) [ Time Frame: up to 100 days post last dose ]Area under the curve from time zero to infinity (AUC∞).
- PK: Area Under the Curve From Time Zero To The Time Of The Last Quantifiable Concentration (AUC0-t) [ Time Frame: up to 100 days post last dose ]Area under the curve from time zero to the time of the last quantifiable concentration (AUC0-t).
- PK: Maximum Observed Concentration (Cmax) [ Time Frame: up to 100 days post last dose ]Maximum observed concentration (Cmax).
- PK: Time of the Maximum Observed Concentration (Tmax) [ Time Frame: up to 100 days post last dose ]Time of the maximum observed concentration (Tmax).
- PK: Terminal Elimination Half-Life (T1/2) [ Time Frame: up to 100 days post last dose ]Investigational Product (IP) terminal elimination half-life (T1/2).
- PK: Clearance (CL) [ Time Frame: up to 100 days post last dose ]Investigational Product (IP) Clearance (CL).
- PK: Volume Of Distribution (Vz) [ Time Frame: up to 100 days post last dose ]Investigational Product (IP) volume of distribution (Vz).
- PK: AUC Over A Dosing Interval (AUCtau) [ Time Frame: up to 100 days post last dose ]AUC over a dosing interval (AUCtau).
- PK: Trough Concentration (Ctrough) [ Time Frame: up to 100 days post last dose ]Investigational Product (IP) trough concentration (Ctrough).
- PK: Volume of Distribution at Steady State (Vss) [ Time Frame: up to 100 days post last dose ]Investigational Product (IP) volume of distribution at steady state (Vss).
- Immunogenicity: Anti-drug antibodies (ADA) [ Time Frame: up to 100 days post last dose ]Incidence and concentration of anti-drug antibodies.
- Efficacy: Best Overall Response (BOR) [ Time Frame: up to 100 days post last dose ]BOR is determined using Response Elevation Criteria in Solid Tumors (RECIST) 1.1 and immune Response Elevation Criteria in Solid Tumors (iRECIST) guidelines for response criteria for use in trials testing immunotherapeutics for solid tumors and Lugano criteria and lymphoma response to immunomodulatory therapy criteria (LYRIC) for lymphoma.
- Efficacy: Objective Response Rate (ORR) [ Time Frame: up to 100 days post last dose ]ORR is determined using Response Elevation Criteria in Solid Tumors (RECIST) 1.1 and immune Response Elevation Criteria in Solid Tumors (iRECIST) guidelines for response criteria for use in trials testing immunotherapeutics for solid tumors and Lugano criteria and lymphoma response to immunomodulatory therapy criteria (LYRIC) for lymphoma.
- Efficacy: Duration Of Response (DOR) [ Time Frame: up to 100 days post last dose ]DOR is determined using Response Elevation Criteria in Solid Tumors (RECIST) 1.1 and immune Response Elevation Criteria in Solid Tumors (iRECIST) guidelines for response criteria for use in trials testing immunotherapeutics for solid tumors and Lugano criteria and lymphoma response to immunomodulatory therapy criteria (LYRIC) for lymphoma.
- Efficacy: Progression-Free Survival (PFS) [ Time Frame: up to 100 days post last dose ]PFS is determined using Response Elevation Criteria in Solid Tumors (RECIST) 1.1 and immune Response Elevation Criteria in Solid Tumors (iRECIST) guidelines for response criteria for use in trials testing immunotherapeutics for solid tumors and Lugano criteria and lymphoma response to immunomodulatory therapy criteria (LYRIC) for lymphoma.
- Efficacy: Overall Survival (OS) [ Time Frame: up to 100 days post last dose ]OS is determined using Response Elevation Criteria in Solid Tumors (RECIST) 1.1 and immune Response Elevation Criteria in Solid Tumors (iRECIST) guidelines for response criteria for use in trials testing immunotherapeutics for solid tumors and Lugano criteria and lymphoma response to immunomodulatory therapy criteria (LYRIC) for lymphoma.
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: 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.
Exclusion Criteria:
- 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.
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
Locations
Show 21 study locations
Sponsors and Collaborators
AbbVie
I-Mab Biopharma Co. Ltd.
Investigators
| Study Director: | ABBVIE INC. | AbbVie |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT03934814 |
| Other Study ID Numbers: |
TJ011133EDI101 KEYNOTE KN-A21 ( Registry Identifier: Merk ) |
| First Posted: | May 2, 2019 Key Record Dates |
| Last Update Posted: | August 24, 2022 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by AbbVie:
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Solid Tumor Lymphoma |
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 |