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Virus Therapy

NX-5948 for B-cell Cancer

Phase 1

Recruiting

Research Sponsored by Nurix Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Radiographically measurable disease per response criteria specific to the malignancy. Target lymph nodes must be > 1.5 cm and extranodal lesions must be ≥ 1.0 cm in longest diameter

Age ≥18 years

Must not have

Chimeric antigen receptor (CAR) T-cell therapy within 100 days prior to start of study drug (within 30 days prior to start of study drug for Phase 1b). Must have evidence of B-cell recovery if patient received prior CAR T-cell therapy

Prior small molecule therapy within 4 weeks or 5 half-lives (whichever is shorter) of planned start of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug for advanced B-cell cancer. Scientists will look at safety and effectiveness.

Who is the study for?

Adults over 18 with certain advanced B-cell malignancies, measurable disease, and in good physical condition (ECOG 0-1) can join. They must have tried at least two prior treatments without success. Excluded are those recently treated with chemotherapy, monoclonal antibodies, small molecules or immunosuppressives; have heart issues, uncontrolled blood pressure or bleeding disorders; received CAR T-cell therapy or stem cell transplant too recently.

What is being tested?

The trial is testing NX-5948's safety and effectiveness against various B-cell cancers. It's a first-in-human study that includes an initial phase to find the right dose and a second phase to see how well it works on specific cancer types.

What are the potential side effects?

Potential side effects of NX-5948 aren't detailed here as this is a first-in-human trial. However, common side effects for new cancer drugs may include nausea, fatigue, allergic reactions, blood count changes leading to increased infection risk or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer can be measured on scans, with visible tumors.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had CAR T-cell therapy in the last 100 days (30 days for Phase 1b) or I have evidence of B-cell recovery after such therapy.

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I haven't taken small molecule therapy in the last 4 weeks or 5 half-lives.

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I do not have severe heart issues like uncontrolled irregular heartbeat or advanced heart failure.

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I do not have serious heart conditions or uncontrolled high blood pressure.

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I have a condition that increases my risk of bleeding.

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I have not had serious bleeding in the last 28 days.

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I do not have uncontrolled autoimmune blood disorders.

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I haven't had radiotherapy for cancer treatment within the last 2 weeks.

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I have had a recent heart attack, unstable chest pain, or a procedure to open my heart's arteries.

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I have had a clotting event, stroke, or bleeding in the brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with protocol specified dose-limiting toxicities

Number of participants with treatment-emergent adverse events (TEAEs); Grade 3, 4, 5 TEAEs, serious adverse events (SAEs), TEAEs leading to study drug discontinuation, deaths due to TEAEs, and all deaths

To establish the maximum tolerated dose and/or recommended Phase 1b dose(s)

+1 more

Secondary study objectives

Complete response (CR) rate / CR with incomplete marrow recovery as assessed by the Investigator

Duration of response (DOR) as assessed by the Investigator

Pharmacodynamic (PD) profile of NX-5948: Changes from baseline of BTK levels in B-cells

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Phase 1b in WMExperimental Treatment1 Intervention

WM with prior exposure to a BTKi and an additional line of therapy

Group II: Phase 1b in PCNSL/SCNSLExperimental Treatment1 Intervention

PCNSL patients who have progressed or had no response to at least 2 prior lines of therapy, or SCNSL patients meeting criteria for non-CLL/SLL arms above with secondary CNS involvement of lymphoma

Group III: Phase 1b in MZLExperimental Treatment1 Intervention

MZL (EMZL, MALT, NMZL, SMZL) with prior exposure to an anti-CD20 mAb-based chemo-immunotherapy regimen and an additional line of therapy

Group IV: Phase 1b in MCLExperimental Treatment1 Intervention

MCL with prior exposure to a BTKi and an anti-CD20 monoclonal antibody (mAb)-based chemo-immunotherapy regimen

Group V: Phase 1b in FLExperimental Treatment1 Intervention

FL (grade 1-3a) with prior exposure to an anti-CD20 mAb-based chemoimmunotherapy regimen and an additional line of therapy

Group VI: Phase 1b in DLBCLExperimental Treatment1 Intervention

DLBCL with prior exposure to an anthracycline (unless previously deemed ineligible to receive), an anti-CD20 mAb-based chemoimmunotherapy regimen, and an additional line of therapy

Group VII: Phase 1b in CLL or SLLExperimental Treatment1 Intervention

CLL or SLL with prior exposure to both a Bruton's tyrosine kinase inhibitor (BTKi) and BCL-2 inhibitor, unless previously deemed ineligible for those therapies. Patients enrolled in CLL/SLL arm will be randomized to one of two dose levels. This is the only randomization component in the trial.

Group VIII: Phase 1a Dose EscalationExperimental Treatment1 Intervention

Multiple dose levels of NX-5948 to be evaluated; determination of Maximum Tolerated Dose/Phase 1b recommended dose(s)

0 / 12Eligibility criteria met