Solid TumorPhase 1NCT03934814
Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma
A Phase 1 study testing TJ011133, Pembrolizumab and Rituximab in people with Solid Tumor and Lymphoma, run by I-Mab Biopharma US Limited at 21 sites in 2 countries.
Trial summary
The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Lymphoma
- What is being tested?
- TJ011133, Pembrolizumab and Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 16 Apr 2019to 10 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States12 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Alabama - Birmingham
Birmingham, Alabama, 35233
Henry Ford Cancer Institute/Henry Ford Hospital
Detroit, Michigan, 48202
Mayo Clinic
Jacksonville, Florida, 32224
Horizon Oncology
Lafayette, Indiana, 47905
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Yale School of Medicine
New Haven, Connecticut, 06510
NYU Langone Health
New York, New York, 10016
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic
Scottsdale, Arizona, 85259
Seattle Cancer Care Alliance
Seattle, Washington, 98109
China9 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
The Fourth Hpspital of Hebei Medical University(Hebei Cancer Hospital)
Shijiazhuang, Hebei, 50011
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
HuBei Cancer Hospital
Wuhan, Hubei, 430000
Henan Cancer Hospital
Zhengzhou, Henan, 450003
About this study
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
The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.
Read the 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 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.
- Conditions
- Solid Tumor, Lymphoma
- Being tested
- TJ011133, Pembrolizumab, Rituximab
- Keywords
- Solid Tumor, Lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ011133Drug
TJ011133 will be administered weekly.
PembrolizumabDrug
Also called KEYTRUDA®
Pembrolizumab will be administered every 3 weeks.
RituximabDrug
Also called Rituxan, MabThera
Rituximab will be administered weekly for 5 doses, then followed by monthly doses.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: TJ011133 |
| Part 1B - Combination therapy of TJ011133 with pembrolizumab | Experimental | TJ011133 will be administered Q1W, starting at 20 mg/ kg, in combination with pembrolizumab. Receives: Drug: TJ011133; Drug: Pembrolizumab |
| Part 1C - Combination therapy of TJ011133 with rituximab | Experimental | TJ011133 will be administered Q1W, starting at 20 mg/kg, in combination with rituximab. Receives: Drug: TJ011133; Drug: Rituximab |
| 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. Receives: Drug: TJ011133; Drug: Pembrolizumab; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 100 days post last dose
Maximum Tolerated Dose (MTD) for Both Monotherapy and Combination Therapy
Based on DLT definitions.
Measured: 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.
Measured: up to 100 days post last dose
Secondary outcomes (16)
Pharmacokinetic (PK): Area Under the Curve From Time Zero To Infinity (AUC∞)
Area under the curve from time zero to infinity (AUC∞).
Measured: 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)
Area under the curve from time zero to the time of the last quantifiable concentration (AUC0-t).
Measured: up to 100 days post last dose
PK: Maximum Observed Concentration (Cmax)
Maximum observed concentration (Cmax).
Measured: up to 100 days post last dose
PK: Time of the Maximum Observed Concentration (Tmax)
Time of the maximum observed concentration (Tmax).
Measured: up to 100 days post last dose
PK: Terminal Elimination Half-Life (T1/2)
Investigational Product (IP) terminal elimination half-life (T1/2).
Measured: up to 100 days post last dose
PK: Clearance (CL)
Investigational Product (IP) Clearance (CL).
Measured: up to 100 days post last dose
PK: Volume Of Distribution (Vz)
Investigational Product (IP) volume of distribution (Vz).
Measured: up to 100 days post last dose
PK: AUC Over A Dosing Interval (AUCtau)
AUC over a dosing interval (AUCtau).
Measured: up to 100 days post last dose
PK: Trough Concentration (Ctrough)
Investigational Product (IP) trough concentration (Ctrough).
Measured: 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).
Measured: up to 100 days post last dose
Immunogenicity: Anti-drug antibodies (ADA)
Incidence and concentration of anti-drug antibodies.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 100 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start16 Apr 2019
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- I-Mab Biopharma US Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934814
- Sponsor's protocol ID
- TJ011133EDI101
- Other IDs
- KEYNOTE A21, MK-3475-A21
- Status last verified
- Jun 2024
- First submitted
- 26 Apr 2019
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03934814
- Acronym / sponsor ID
- TJ011133EDI101
- Conditions
- Solid Tumor, Lymphoma
- Keywords
- Solid Tumor, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- I-Mab Biopharma US LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1A - TJ011133 Monotherapy | Experimental | Drug: TJ011133TJ011133 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 | Experimental | Drug: TJ011133, Drug: PembrolizumabTJ011133 will be administered Q1W, starting at 20 mg/ kg, in combination with pembrolizumab. |
| Part 1C - Combination therapy of TJ011133 with rituximab | Experimental | Drug: TJ011133, Drug: RituximabTJ011133 will be administered Q1W, starting at 20 mg/kg, in combination with rituximab. |
| Part 2 - Dose Expansion | Experimental | Drug: TJ011133, Drug: Pembrolizumab, Drug: Rituximab30 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TJ011133TJ011133 will be administered weekly. | Drug | Part 1A - TJ011133 Monotherapy, Part 1B - Combination therapy of TJ011133 with pembrolizumab, Part 1C - Combination therapy of TJ011133 with rituximab, Part 2 - Dose Expansion |
| PembrolizumabAlso: KEYTRUDA®Pembrolizumab will be administered every 3 weeks. | Drug | Part 1B - Combination therapy of TJ011133 with pembrolizumab, Part 2 - Dose Expansion |
| RituximabAlso: Rituxan, MabTheraRituximab will be administered weekly for 5 doses, then followed by monthly doses. | Drug | Part 1C - Combination therapy of TJ011133 with rituximab, Part 2 - Dose Expansion |
Primary outcome
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.
16 secondary outcomes
Pharmacokinetic (PK): Area Under the Curve From Time Zero To Infinity (AUC∞)
Time frame: 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)
Time frame: up to 100 days post last dose
PK: Maximum Observed Concentration (Cmax)
Time frame: up to 100 days post last dose
PK: Time of the Maximum Observed Concentration (Tmax)
Time frame: up to 100 days post last dose
PK: Terminal Elimination Half-Life (T1/2)
Time frame: up to 100 days post last dose
PK: Clearance (CL)
Time frame: up to 100 days post last dose
PK: Volume Of Distribution (Vz)
Time frame: up to 100 days post last dose
PK: AUC Over A Dosing Interval (AUCtau)
Time frame: up to 100 days post last dose
PK: Trough Concentration (Ctrough)
Time frame: up to 100 days post last dose
PK: Volume of Distribution at Steady State (Vss)
Time frame: up to 100 days post last dose
Immunogenicity: Anti-drug antibodies (ADA)
Time frame: up to 100 days post last dose
Efficacy: Best Overall Response (BOR)
Time frame: up to 100 days post last dose
Efficacy: Objective Response Rate (ORR)
Time frame: up to 100 days post last dose
Efficacy: Duration Of Response (DOR)
Time frame: up to 100 days post last dose
Efficacy: Progression-Free Survival (PFS)
Time frame: up to 100 days post last dose
Efficacy: Overall Survival (OS)
Time frame: up to 100 days post last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TJ011133, Pembrolizumab and Rituximab in people with Solid Tumor and Lymphoma, run by I-Mab Biopharma US Limited at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLT) (time frame: 21 or 28 days, depending on study part). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.