Condition or disease | Intervention/treatment | Phase |
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Peripheral T Cell Lymphoma Diffuse Large B Cell Lymphoma Biliary Tract Cancer Extranodal NK T Cell Lymphoma, Nasal | Biological: STI-3031 | Phase 2 |
This is an open-label, multicenter, global Phase 2 basket study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of STI-3031 in patients with selected relapsed or refractory (R/R) malignancies. The study will be conducted as separate Phase 2, single arm substudies for each of the indications below:
All participants will receive the study intervention, STI-3031.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 220 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label, Multicenter, Global Phase 2 Basket Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of STI-3031 in Patients With Selected Relapsed or Refractory Malignancies. |
Estimated Study Start Date : | January 2022 |
Estimated Primary Completion Date : | January 2024 |
Estimated Study Completion Date : | July 2024 |
Arm | Intervention/treatment |
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Experimental: Extranodal NK/T-cell lymphoma (ENKTL)
Intravenous STI-3031 (anti-PD-L1 antibody)
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Biological: STI-3031
anti-PD-L1 antibody
Other Name: IMC-001
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Experimental: Peripheral T-cell lymphomas (PTCL)
Intravenous STI-3031 (anti-PD-L1 antibody)
|
Biological: STI-3031
anti-PD-L1 antibody
Other Name: IMC-001
|
Experimental: Diffuse large B-cell lymphoma (DLBCL)
Intravenous STI-3031 (anti-PD-L1 antibody)
|
Biological: STI-3031
anti-PD-L1 antibody
Other Name: IMC-001
|
Experimental: Biliary tract cancers (BTC)
Intravenous STI-3031 (anti-PD-L1 antibody)
|
Biological: STI-3031
anti-PD-L1 antibody
Other Name: IMC-001
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Prior treatment:
Exclusion Criteria:
Seropositive for or active viral infection with HIV, unless the following are met:
Any of the following cardiac diseases currently or within the last 6 months:
Contact: Mike Royal, MD JD MBA | 858-203-4100 ext 4146 | mroyal@sorrentotherapeutics.com |
Tracking Information | |||||
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First Submitted Date ICMJE | June 24, 2019 | ||||
First Posted Date ICMJE | June 27, 2019 | ||||
Last Update Posted Date | July 15, 2020 | ||||
Estimated Study Start Date ICMJE | January 2022 | ||||
Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Objective Response Rate [ Time Frame: Approximately 24 months ] Percentage of participants achieving a Complete Response (CR) or Partial Response (PR) at any time during the study as assessed by an Independent Response Committee (IRC) per the Lugano criteria with LYRIC modification or RECIST 1.1
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of STI-3031 (an Anti-PD-L1 Antibody) in Patients With Selected Relapsed/Refractory Malignancies | ||||
Official Title ICMJE | An Open-label, Multicenter, Global Phase 2 Basket Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of STI-3031 in Patients With Selected Relapsed or Refractory Malignancies. | ||||
Brief Summary | This study evaluates the efficacy, as measured by the objective response rate, of STI-3031, an anti-PD-L1 antibody, in previously treated patients with selected advanced lymphomas or biliary tract cancer. | ||||
Detailed Description |
This is an open-label, multicenter, global Phase 2 basket study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of STI-3031 in patients with selected relapsed or refractory (R/R) malignancies. The study will be conducted as separate Phase 2, single arm substudies for each of the indications below:
All participants will receive the study intervention, STI-3031. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Biological: STI-3031
anti-PD-L1 antibody
Other Name: IMC-001
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
220 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 2024 | ||||
Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03999658 | ||||
Other Study ID Numbers ICMJE | STI-3031-001 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Sorrento Therapeutics, Inc. | ||||
Study Sponsor ICMJE | Sorrento Therapeutics, Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Sorrento Therapeutics, Inc. | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |