OPB-31121 50 mg by mouth 2 times a day on Days 1-21 of each 28-day cycle.

50 mg by mouth 2 times a day on Days 1-21 of each 28-day cycle.

OPB-31121

David S. Hong, MD

The goal of this clinical research study is to find the highest tolerable dose of OPB-31121 that can be given to patients with an advanced solid tumor. The safety of this drug will also be studied.

The Study Drug:

OPB-31121 is designed to block certain proteins in cancer cells that cause the cancer cells to reproduce and form more cancer cells.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of OPB-31121 based on when you joined this study. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of OPB-31121 is found.

Study Drug Administration:

On Days 1-21 of each 28-day cycle, you will take the study drug by mouth 2 times a day. You should take the study drug with at least 1 full glass of room temperature, still (non-carbonated) water, within 30 minutes after eating a snack or meal. You should either remain sitting upright or standing for at least 30 minutes after you take the study drug. You will be given directions by the study doctor, the study nurse, and/or the study pharmacist on how to take the study drug at home.

Study Visits:

On Day 1 of Cycle 1, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* You will have 5 ECGs: 1 before the morning dose of study drug and at 1, 2, 4, and 8 hours after the morning dose.
* Blood (about 3 tablespoons) will be drawn for routine tests.
* Your performance status will be recorded.
* You will be asked about any drugs you may be taking and if you have experienced any side effects.
* Blood (about 2 teaspoons each time) will be drawn before the morning dose and then 6 more times over the next 12 hours after the dose for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points.
* Blood (about 2 teaspoons) for pharmacodynamic (PD) testing will be drawn before the morning dose. PD testing is used to look at how the level of study drug in your body may affect the disease.
* Blood (about 1 teaspoon) will be drawn for pharmacogenomic (PGx) testing. PGx testing looks at how differences in people's genes may affect if and how well the study drug may affect the disease.
* Women who are able to become pregnant will have a urine pregnancy test.

On Day 2 of Cycle 1, before your morning dose of study drug, the following tests and procedures will be performed:

* Blood (about 1 teaspoon) will be drawn for a troponin test.
* Blood (about 4 teaspoons) will be drawn for PK and PD testing.
* Your performance status will be recorded.
* You will be asked about any drugs you may be taking and if you have experienced any side effects.

On Days 8, 15, 21, and 28 of Cycle 1, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* You will have an ECG.
* Blood (about 3 tablespoons on Days 8 and 15; about 1 tablespoon on Days 21 and 28) and urine will be collected for routine tests.
* Your performance status will be recorded.
* You will be asked about any drugs you may be taking and if you have experienced any side effects.

On Day 21 of Cycle 1, blood (about 2 teaspoons each time) will be drawn for PK testing before the morning dose and then 6 more times over the next 12 hours after the dose. Blood (about 2 teaspoons each time) will also be drawn for PD testing.

On Day 22 of Cycle 1, before your morning dose of study drug, the following tests and procedures will be performed:

* Your performance status will be recorded.
* You will be asked about any drugs you may be taking and if you had any side effects from them.
* Blood (about 2 teaspoons) will be drawn for PK testing before your morning dose of the study drug.

On Days 1, 15, and 28 of Cycles 2 and beyond, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your weight and vital signs.
* Your performance status will be recorded.
* You will be asked about any drugs you may be taking and if you had any side effects from them.
* You will have an ECG.
* You will have an echocardiogram or MUGA scan.
* Blood (about 3 tablespoons) will be drawn for routine tests.
* You will be asked about any drugs you may be taking and if you have experienced any side effects.
* Women who are able to become pregnant will have a urine pregnancy test.

About every 8 weeks, you will have an x-ray, CT scan, or MRI scan to check the status of the disease.

Length of Study:

You may continue taking the study drug for as long as you are benefitting. You will be taken off study if the disease gets worse, you experience intolerable side effects, or your doctor thinks that it is no longer in your best interest to receive the study drug.

You may choose to stop taking the study drug at any time. You should tell the study doctor right away if you are thinking about stopping your participation in this study. The study doctor will talk to you about how to safely stop taking the study drug.

End-of-Study Visi:t

Within 14 days after the last dose of study drug, you will return for a final visit. The following tests and procedures will be performed at the final visit:

* You will have a physical exam, including measurement of your vital signs.
* You will have an ECG.
* Blood (about 4 tablespoons) and urine will be collected for routine tests.
* You will have either an ECHO or MUGA scan.
* You will have an x-ray, CT scan, or MRI scan to check the status of the disease.
* Your performance status will be recorded.
* You will be asked about any drugs you may be taking and if you have experienced any side effects.

Follow-Up:

You will be called about 30 days after the last dose of OPB-31121 and asked if you have experienced any new or ongoing side effects.

This is an investigational study. OPB-31121 is not FDA approved or commercially available. At this time, OPB-31121 is only being used in research.

Up to 36 patients will take part in this multicenter study. Up to 18 will be enrolled at M. D. Anderson.

STAT3 Inhibitor for Solid Tumors

A Phase I, Open-label, Dose Escalation, Non-randomized Study to Assess the Pharmacokinetics, Dose Limiting Toxicity, and Maximum Tolerated Dose of OPB-31121 in Subjects With Advanced Solid Tumors

The MTD is defined as the highest dose level at which \< 2 of 6 subjects experience dose limiting toxicity (DLT) during the first cycle.

Otsuka Pharmaceutical Development & Commercialization, Inc.

M.D. Anderson Cancer Center

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants will receive ascending doses of VVD-130850, orally, once daily in 21-day treatment cycles during the dose escalation phase.

Participants will receive ascending doses of VVD-130850, orally, once daily, along with pembrolizumab intravenous (IV) infusion, every 3 weeks (Q3W) in 21-day treatment cycles during the dose escalation phase.

Participants will receive VVD-130850 at recommended dose for expansion (RDE), orally, once daily in 21-day treatment cycles during the dose expansion phase.

Participants will receive VVD-130850 at RDE orally, once daily along with pembrolizumab IV infusion, Q3W in 21-day treatment cycles during the dose expansion phase.

VVD-130850

Vividion Clinical Trial Call Center

A FIH study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VVD-130850, as single agent and in combination with checkpoint inhibition, in participants with advanced solid and hematologic tumors.

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors

A Phase 1, Open-Label, 2-Part, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of the STAT3 Inhibitor VVD-130850 as Single Agent and in Combination With Checkpoint Inhibition in Participants With Advanced Solid and Hematologic Tumors

Incidence and severity of DLTs will be assessed per DLT criteria set forth in the protocol based on adverse events (AEs) evaluated per National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Number of participants with changes in QT/QTc interval and other ECG parameters will be assessed.

The RDE will be based on safety, pharmacokinetics, pharmacodynamic biomarker data, and preliminary anti-tumor activity collected during the study as defined by the safety review committee.

ORR is defined as the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.

DOR is defined as the time from initial response of CR or PR to progressive disease or death, whichever comes first per RECIST version 1.1 by investigator assessment.

PFS is defined as the time from the date of randomization to the time of confirmed disease progression or death, whichever occurs first per RECIST version 1.1 by investigator assessment.

DCR is defined as the percentage of participants achieving CR or PR, or stable disease (SD) per RECIST version 1.1 by investigator assessment.

Vividion Therapeutics, Inc.

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Durvalumab

Immunoglobulins

Tremelimumab

MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion

MEDI4736

Tremelimumab is an anti-CTLA4 monoclonal antibody (MAb) administered via intravenous infusion

tremelimumab

AZD9150 is an antisense oligonucleotide (ASO) administered via intravenous infusion

AZD9150

MedImmune LLC

The purpose of this study is to evaluate the safety, tolerability, and efficacy of MEDI4736 (durvalumab) alone and in combination with either tremelimumab or AZD9150 in adult subjects with relapsed or refractory dIffuse large B-cell lymphoma.

This is a multicenter, open-label, dose-escalation and dose-expansion study of MEDI4736 (durvalumab) as monotherapy or in combination with either tremelimumab or AZD9150. The objectives are to describe any dose-limiting toxicities, determine the maximum tolerated dose, and evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics, and pharmacodynamics of MEDI4736 as monotherapy or in combination with either tremelimumab or AZD9150 in adult subjects with relapsed or refractory diffuse large B-cell lymphoma.

MEDI4736 Alone and in Combination With Tremelimumab or AZD9150 in Adult Subjects With Relapsed/Refractory DLBCL (D4190C00023)

A Phase 1b Study to Evaluate the Safety and Efficacy of MEDI4736 as Monotherapy and in Combination With Tremelimumab or AZD9150 in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma.

Changes from baseline in laboratory parameters, vital signs, and ECGs

Behaviors and Mental Disorders

Aggression

Antirheumatic Agents

Amino Acids

Acalabrutinib

Rituximab

Magrolimab

Immunologic Factors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

AZD9150 given in combination with acalabrutinib

AZD6738 in combination with acalabrutinib

Hu5F9-G4/rituximab in combination with acalabrutinib

AZD5153 in combination with acalabrutinib

AZD9150 will be administered as a 1-hour intravenous (IV) infusion on Days 1, 3, 5 of Cycle 1, followed by weekly infusions (starting Day 8 of Cycle 1 and beyond).

Acalabrutinib will be administered orally twice daily (bid).

AZD6738 will be administered orally twice daily (bid).

AZD6738

HU5F9-G4 infusions will be given on Weekly (Day 1, 8, 15, and 22) during the first two 28-day cycles, then will be given every two weeks (Day 1 and Day 15) in Cycle 3 and beyond.

Hu5F9-G4

Rituximab infusions will be given Weekly starting on Day 8 (Day 8, 15, and 22) during the first 28-day cycle (4 weeks), then Day 1 of each 4 week cycle for Cycles 2-6. Starting with Cycle 8, Rituximab will be infused on Day 1 of every other cycle (every 8 weeks).

AZD5153 will be administered orally once per day (qd).

AZD5153

Ian Flinn, MD, PhD

This is a Phase 1 platform protocol designed to evaluate various targeted agents for the treatment of relapsed/refractory aggressive Non-Hodgkin's Lymphoma (NHL).

This is a Phase 1 platform protocol designed to evaluate various targeted agents for the treatment of relapsed/refractory aggressive Non-Hodgkin's lymphoma (NHL). Each study arm will be conducted in a predefined disease subset. All study arms are open label and allocation to each study arm will not be randomized.

As this master platform protocol has multiple study arms, subjects can be screened for several study arms at once. Likewise, a subject who ends participation in one study arm may be rescreened for participation in another (separate) study arm.

The primary objective of the study is to evaluate the safety of targeted agents for the treatment of relapsed/refractory aggressive Non-Hodgkin's Lymphoma (NHL). This protocol has a modular design, with the potential for future treatment arms to be added via protocol amendment.

Platform Study for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma (PRISM Study)

PRISM: A Platform Protocol for the Treatment of Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

The overall response rate (ORR) is defined as the rate of subjects who achieve either a partial response (PR) or complete response (CR) as assessed by investigators before receiving any other anticancer therapy.

Duration of Response (DOR) is defined as the time from the first objective response of CR or PR to the time of documented disease progression or death due to any cause, whichever occurs first.

Progression free survival (PFS) is defined as the time from first dose date to documented objective disease progression, or death from any cause, whichever occurs first. Disease progression will be determined by the investigators per standard response criteria as outlined in each respective study arm.

Overall Survival (OS) is defined as the time from first dose until the date of death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
STAT3 Inhibitor for Solid Tumors	NCT00955812	Advanced Cancer Solid Tumor	OPB-31121	18 Years -	M.D. Anderson Cancer Center
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors	NCT06188208	Advanced Solid ... Advanced Hemato...	VVD-130850 Pembrolizumab	18 Years -	Vividion Therapeutics, Inc.
MEDI4736 Alone and in Combination With Tremelimumab or AZD9150 in Adult Subjects With Relapsed/Refractory DLBCL (D4190C00023)	NCT02549651	Diffuse Large B...	MEDI4736 tremelimumab AZD9150	18 Years -	MedImmune LLC
Platform Study for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma (PRISM Study)	NCT03527147	NHL DLBCL Non-hodgkin's L... Diffuse Large B...	AZD9150 Acalabrutinib AZD6738 Hu5F9-G4 Rituximab AZD5153	18 Years - 130 Years	Acerta Pharma BV

Spots Global Cancer Trial Database for stat3

Every month we try and update this database with for stat3 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for stat3

Every month we try and update this database with for stat3 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for stat3 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.