Active — Not RecruitingPhase 1

Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies

United States437 participantsStarted 2020-03-24

Plain-language summary

The purpose of this study is to determine the safety, tolerability; and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib and obinutuzumab.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. MZL i. R/R extranodal, splenic, or nodal MZL defined as disease that relapsed after, or was refractory to, at least one prior therapy ii. Active disease requiring treatment
✓. FL i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy
✓. DLBCL i. R/R DLBCL (including all subtypes of DLBCL) defined as disease that relapsed after, or was refractory to, at least two prior systemic therapies and has either progressed following or is not a candidate for autologous stem cell transplant (due to comorbidities or non-responsiveness to salvage chemotherapy)
✓. Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Part 1 that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter's transformation) are not eligible for Part 1
✓. CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria i. Disease characterized as Treatment Naive (TN) or R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy ii. Requiring treatment as defined by history
✓. WHO-defined MCL i. R/R MCL defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy; ii. Requiring treatment in the opinion of the investigator
✓. CLL: at least 1 lymph node \> 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions or clonal lymphocytes measured by flow cytometry
✓. DLBCL, FL, MZL, MCL, or SLL: at least 1 lymph node \> 1.5 cm in longest diameter OR 1 extranodal lesion \> 1.0 cm in the longest diameter, measurable in at least 2 perpendicular dimensions. For MZL, isolated splenomegaly is considered measurable for this study

What they're measuring

Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)

Timeframe: Up to 30 days after the last dose of study drug, an average of 18 months

Number of Participants Experiencing Serious Adverse Events (SAEs)

Timeframe: Up to 30 days after the last dose of study drug, an average of 18 months

Number of Participants Experiencing Adverse Events (AEs) leading to discontinuation of Sonrotoclax

Timeframe: Up to 30 days after the last dose of study drug, an average of 18 months

Part 1, Part 3: Maximum Tolerated Dose (MTD) of Sonrotoclax

Timeframe: Up to approximately 2 months

Part 1, Part 3, Part 5: RP2D of Sonrotoclax

Timeframe: Day 1 to last dose of study drug, an average of 18 months

Part 1, Part 3, Part 5: Number of participants experiencing tumor lysis syndrome (TLS) relevant events

Timeframe: Up to 30 days after the last dose of study drug, an average of 18 months

Part 1, Part 3, Part 5: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs

Timeframe: Up to approximately 2 months

Trial details

NCT IDNCT04277637

SponsorBeOne Medicines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05-31

View on ClinicalTrials.gov More Mature B-Cell Malignancies trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. MZL i. R/R extranodal, splenic, or nodal MZL defined as disease that relapsed after, or was refractory to, at least one prior therapy ii. Active disease requiring treatment
✓. FL i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy
✓. DLBCL i. R/R DLBCL (including all subtypes of DLBCL) defined as disease that relapsed after, or was refractory to, at least two prior systemic therapies and has either progressed following or is not a candidate for autologous stem cell transplant (due to comorbidities or non-responsiveness to salvage chemotherapy)
✓. Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Part 1 that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter's transformation) are not eligible for Part 1
✓. CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria i. Disease characterized as Treatment Naive (TN) or R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy ii. Requiring treatment as defined by history
✓. WHO-defined MCL i. R/R MCL defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy; ii. Requiring treatment in the opinion of the investigator
✓. CLL: at least 1 lymph node \> 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions or clonal lymphocytes measured by flow cytometry
✓. DLBCL, FL, MZL, MCL, or SLL: at least 1 lymph node \> 1.5 cm in longest diameter OR 1 extranodal lesion \> 1.0 cm in the longest diameter, measurable in at least 2 perpendicular dimensions. For MZL, isolated splenomegaly is considered measurable for this study

What they're measuring

Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)

Timeframe: Up to 30 days after the last dose of study drug, an average of 18 months

Number of Participants Experiencing Serious Adverse Events (SAEs)

Timeframe: Up to 30 days after the last dose of study drug, an average of 18 months

Number of Participants Experiencing Adverse Events (AEs) leading to discontinuation of Sonrotoclax

Timeframe: Up to 30 days after the last dose of study drug, an average of 18 months

Part 1, Part 3: Maximum Tolerated Dose (MTD) of Sonrotoclax

Timeframe: Up to approximately 2 months

Part 1, Part 3, Part 5: RP2D of Sonrotoclax

Timeframe: Day 1 to last dose of study drug, an average of 18 months

Part 1, Part 3, Part 5: Number of participants experiencing tumor lysis syndrome (TLS) relevant events

Timeframe: Up to 30 days after the last dose of study drug, an average of 18 months

Part 1, Part 3, Part 5: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs

Timeframe: Up to approximately 2 months