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New treatment option for Non Hodgkin Lymphoma
Official title SB-4826 in Adult Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphomas
ClinicalTrials.gov ID: NCT07222631
What this study is testing
What is SB-4826?
SB-4826 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for non hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn what dose of the drug SB-4826 can be given safely in patients with solid tumors and non-Hodgkin lymphomas. This drug will be used alone in patients with solid tumors, and will be used alone or in combination with rituximab in patients with non-Hodgkin lymphomas.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1 - Aged 18 and older.
- 2- Capable of giving signed informed consent.
- 3- Phase 1 (Dose-Escalation): Histologically or cytologically confirmed locally advanced or metastatic solid tumor or non-Hodgkin lymphomas. For...
- 4- Phase 2 (Dose-Expansion/ Combination Therapy): Histologically or cytologically confirmed non-Hodgkin lymphomas. For indolent non-Hodgkin...
- 5- Participant's malignancy has relapsed after, progressed on, is not a candidate for, is intolerant of, or refuses standard of care therapies.
You likely can't join if
- Inability to take oral medications.
- Use of systemic cancer therapy (e.g., chemotherapy, immunotherapy, biologic, hormonal therapy) within 21 days or 5 half-lives, whichever is shorter.
- Palliative radiation within 7 days before first dose of study drug.
- Use of cellular therapy within 60 days before first dose of study drug.
- Major surgery within 30 days before first dose of study drug.
- Prior solid organ transplant.
See the full eligibility criteria
- 1 - Aged 18 and older.
- 2- Capable of giving signed informed consent.
- 3- Phase 1 (Dose-Escalation): Histologically or cytologically confirmed locally advanced or metastatic solid tumor or non-Hodgkin lymphomas. For indolent non-Hodgkin lymphomas, there must be an indication for systemic...
- 4- Phase 2 (Dose-Expansion/ Combination Therapy): Histologically or cytologically confirmed non-Hodgkin lymphomas. For indolent non-Hodgkin lymphomas, there must be an indication for systemic therapy such as: Local...
- 5- Participant's malignancy has relapsed after, progressed on, is not a candidate for, is intolerant of, or refuses standard of care therapies.
- 6- For solid cancer, at least one measurable lesion based on response evaluation criteria in solid tumors (RECIST v1.1).
- 7- Adequate hematologic parameters unless cytopenia are due to malignancy (i.e. marrow involvement): Hemoglobin ≥ 8 g/dL; Absolute neutrophil count ≥ 1000/microliter or ≥ 750/microliter if Duffy null phenotype; Platelet...
- 8- Adequate organ function defined as: Calculated creatinine clearance ≥ 60 mL/min; Serum alanine aminotransferase and aspartate aminotransferase ≤ 1.5 x upper limit of normal; Total bilirubin ≤ 1.5 x upper limit of...
- 9- All adverse events related to prior therapy or disease (except alopecia) have resolved to grade 2 or less.
- 10- Life expectancy ≥ 3 months.
- 11- Eastern Cooperative Oncology Group Performance Status: ≤ 2
- 12- Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of nonchildbearing potential (WONCBP) OR is a...
- 13- Male Participants: Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 3 months after the last study dose. The 3-month timeframe is...
- Inability to take oral medications.
- Use of systemic cancer therapy (e.g., chemotherapy, immunotherapy, biologic, hormonal therapy) within 21 days or 5 half-lives, whichever is shorter.
- Palliative radiation within 7 days before first dose of study drug.
- Use of cellular therapy within 60 days before first dose of study drug.
- Major surgery within 30 days before first dose of study drug.
- Prior solid organ transplant.
- Clinically significant cardiovascular disease including any of the following within 6 months before first dose of study drug: myocardial infarction or coronary artery bypass grafting, unstable angina pectoris, serious...
- History of any other malignancy in the past 2 years other than completely resected nonmelanoma skin cancer or carcinoma in situ of the uterine cervix, anus, prostate, bladder, breast, or indolent malignancies that do...
- History of or current chronic liver disease, such as active viral hepatitis, drug- or alcohol-related liver disease, metabolic dysfunction-associated steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilson's...
- Mean resting corrected QT interval using Fridericia's formula \> 470 msec.
- Active infection that necessitates treatment within 14 days of first dose of study drug.
- Active hepatitis B or hepatitis C infection regardless of viremia.
- Known history of human immunodeficiency virus infection with viral load \>50 copies/ml at the time of screening.
- Active autoimmune disease requiring \>10 mg of prednisone daily or equivalent, disease-modifying antirheumatic drugs, or immunosuppression.
- Use of medications that are known to be sensitive narrow therapeutic index or moderate sensitive substrates, strong or moderate inhibitors or strong or moderate inducers of cytochrome P450 3A4/5, or sensitive substrates...
- Receipt of any live vaccine (e.g., varicella, pneumococcus) within 30 days of first dose of study drug.
- Receipt of investigational products, including drugs and devices, within 21 days or five half-lives, whichever is shorter, before first dose of study drug.
- History of Grade 3 or higher immune mediated adverse events that were considered drug related to prior immunotherapy (e.g., checkpoint inhibitors, co stimulatory agents).
- Known active central nervous system metastases. Participants with previously treated stable brain metastases may participate.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.