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| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE A21 | Registry Identifier | Merck Sharp & Dohme LLC | |
| MK-3475-A21 | Other Identifier | Merck Sharp & Dohme LLC |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A - TJ011133 Monotherapy | Experimental | 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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| Part 1B - Combination therapy of TJ011133 with pembrolizumab | Experimental | TJ011133 will be administered Q1W, starting at 20 mg/ kg, in combination with pembrolizumab. |
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| Part 1C - Combination therapy of TJ011133 with rituximab | Experimental | TJ011133 will be administered Q1W, starting at 20 mg/kg, in combination with rituximab. |
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| Part 2 - Dose Expansion | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TJ011133 | Drug | TJ011133 will be administered weekly. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK): Area Under the Curve From Time Zero To Infinity (AUC∞) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama - Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Mayo Clinic |
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| Pembrolizumab | Drug | Pembrolizumab will be administered every 3 weeks. |
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| Rituximab | Drug | Rituximab will be administered weekly for 5 doses, then followed by monthly doses. |
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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) | Maximum observed concentration (Cmax). | up to 100 days post last dose |
| PK: Time of the Maximum Observed Concentration (Tmax) | Time of the maximum observed concentration (Tmax). | up to 100 days post last dose |
| PK: Terminal Elimination Half-Life (T1/2) | Investigational Product (IP) terminal elimination half-life (T1/2). | up to 100 days post last dose |
| PK: Clearance (CL) | Investigational Product (IP) Clearance (CL). | up to 100 days post last dose |
| PK: Volume Of Distribution (Vz) | Investigational Product (IP) volume of distribution (Vz). | up to 100 days post last dose |
| PK: AUC Over A Dosing Interval (AUCtau) | AUC over a dosing interval (AUCtau). | up to 100 days post last dose |
| PK: Trough Concentration (Ctrough) | Investigational Product (IP) trough concentration (Ctrough). | up to 100 days post last dose |
| PK: Volume of Distribution at Steady State (Vss) | Investigational Product (IP) volume of distribution at steady state (Vss). | up to 100 days post last dose |
| Immunogenicity: Anti-drug antibodies (ADA) | Incidence and concentration of anti-drug antibodies. | up to 100 days post last dose |
| Efficacy: Best Overall Response (BOR) | 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. | up to 100 days post last dose |
| Efficacy: Objective Response Rate (ORR) | 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. | up to 100 days post last dose |
| Efficacy: Duration Of Response (DOR) | 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. | up to 100 days post last dose |
| Efficacy: Progression-Free Survival (PFS) | 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. | up to 100 days post last dose |
| Efficacy: Overall Survival (OS) | 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. | up to 100 days post last dose |
| 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 |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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