What is the mechanism of action of this treatment?

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, immunotherapy, and targeted therapy. Chemotherapy kills rapidly dividing cells, including cancer cells. Immunotherapy, such as monoclonal antibodies like rituximab, targets specific proteins on lymphoma cells, marking them for destruction by the immune system. Targeted therapies, such as kinase inhibitors, block specific molecules involved in cancer cell growth and survival. Emerging treatments like NX-1607, which is being studied for advanced malignancies, may offer new mechanisms of action by targeting specific pathways or proteins involved in cancer progression. Understanding these mechanisms is crucial for NHL patients as it helps in selecting the most effective treatment based on the specific characteristics of their lymphoma, potentially improving outcomes and minimizing side effects.

What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, such as chemotherapy, immunotherapy, and targeted therapy, have a range of side effects. Chemotherapy often results in nausea, vomiting, hair loss, fatigue, and increased infection risk due to lowered blood cell counts. Immunotherapy, including checkpoint inhibitors, can cause immune-related adverse effects like colitis, pneumonitis, and dermatitis. Targeted therapies may lead to hypertension, liver toxicity, and gastrointestinal issues. These side effects are important considerations when evaluating treatment options for advanced malignancies similar to those targeted by NX-1607.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma (NHL), including monoclonal antibodies like rituximab, which targets the CD20 protein on B cells, and CAR-T cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, which modify a patient's T cells to attack cancer cells. Additionally, small molecule inhibitors like ibrutinib, which targets Bruton's tyrosine kinase, and lenalidomide, an immunomodulatory drug, have been approved. These treatments are designed to target specific pathways or proteins involved in the growth and survival of lymphoma cells, similar to the investigational agent NX-1607, which is being studied for its anti-cancer activity in advanced malignancies.

What other types of research exist?

Promising novel alternatives to NX-1607 for Non-Hodgkin's Lymphoma patients include CAR T-cell therapies such as axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah), bispecific antibodies like mosunetuzumab, and novel antibody-drug conjugates such as polatuzumab vedotin. These therapies have shown significant efficacy in clinical trials and are expected to be key treatment options in 2024.

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NX-1607 for Advanced 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

Minimum of 3 weeks or 5 half-lives (whichever is shorter) since last dose of systemic cancer therapy (unless otherwise specified) or minimum of 2 weeks since last radiotherapy, or minimum of 6 weeks since last systemic therapy with nitrosoureas, antibody-drug conjugate, or radio immuno-conjugate therapy

Accessible tumor (for all cohorts) or lymph node (DLBCL only) for biopsy (Phase 1b only)

Must not have

Unable to swallow capsules or has malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction likely to interfere with the delivery, absorption, or metabolism of NX-1607

Patients with primary refractory EOC defined as patients who do not respond to their first platinum-containing regimen or who relapse less than 6 months after completion of that first platinum-containing regimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing NX-1607, a new experimental drug, in adults with advanced cancers that don't respond to standard treatments. The goal is to see if NX-1607 can safely stop or reduce cancer growth, either by itself or with another drug called paclitaxel. Paclitaxel is a widely used anti-cancer drug for treating various types of solid malignant tumors including breast, ovarian, and lung cancers.

Who is the study for?

Adults with certain advanced cancers (like ovarian, stomach, lung, prostate cancer and more) who have tried standard treatments without success or can't receive them. They must be over 18, not pregnant or breastfeeding, willing to use contraception and follow study rules. People with active brain metastases, recent major surgery or immunotherapy side effects are excluded.

What is being tested?

The trial is testing NX-1607 alone or with Paclitaxel in patients with various advanced malignancies. It's a first-in-human study assessing safety and how well the drug works against cancer.

What are the potential side effects?

Specific side effects of NX-1607 aren't listed but may include typical reactions to cancer drugs like nausea, fatigue, allergic responses and potential risks associated with new investigational medications.

Eligibility Criteria

Inclusion Criteria

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

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It's been enough time since my last cancer treatment.

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I can have a biopsy on my tumor or lymph node (if I have DLBCL).

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I am 18 years old or older.

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My cancer is resistant to platinum-based treatments.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I cannot take pills by mouth or have serious digestive system issues.

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My ovarian cancer did not respond to the first platinum-based treatment or came back within 6 months.

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I had severe side effects from previous immunotherapy.

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I have brain metastases that haven't been treated.

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I do not have any uncontrolled illnesses like high blood pressure, diabetes, or infections needing treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Incidence of immune-related AEs (irAEs), all deaths, and dose-limiting toxicities (DLTs)

Incidence of treatment-emergent adverse events (TEAEs), including Grade ≥ 3 TEAEs, treatment-emergent serious adverse events (SAEs), TEAEs leading to study drug discontinuation, and deaths due to TEAEs

Objective Response Rate (ORR) per disease-specific response criteria as assessed by the Investigator

Secondary study objectives

Disease control rate (DCR) as assessed by the Investigator

Duration of response (DOR) as assessed by the Investigator

Incidence of IrAEs and all deaths

+14 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

13Treatment groups

Experimental Treatment

Group I: Phase 1b Dose Expansion of NX-1607 in combination with PaclitaxelExperimental Treatment2 Interventions

Indications may include but are not limited to, platinum resistant EOC, gastric/GEJ cancer, HSNCC, NSCLC, TNBC, and locally advanced or metastatic urothelial cancer

Group II: Phase 1b Dose Expansion in recurrent melanomaExperimental Treatment1 Intervention

Patients with recurrent and either metastatic or unresectable Melanoma

Group III: Phase 1b Dose Expansion in platinum-resistant EOCExperimental Treatment1 Intervention

Patients with platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma

Group IV: Phase 1b Dose Expansion in mixed solid tumor cohortExperimental Treatment1 Intervention

Cohort of mixed solid tumor indications consisting of patients with MPM, TNBC, locally advanced or metastatic urothelial cancer, cervical cancer, or DLBCL/DLBCL-RT

Group V: Phase 1b Dose Expansion in mCRPCExperimental Treatment1 Intervention

Patients with mCRPC who received a minimum of 2 prior lines of therapy in the advanced setting including androgen receptor-directed therapy and a taxane-based chemotherapy and has PSA or radiographic progression

Group VI: Phase 1b Dose Expansion in advanced gastric/GEJ cancerExperimental Treatment1 Intervention

Patients with recurrent, locally advanced, or metastatic gastric or GEJ adenocarcinoma

Group VII: Phase 1b Dose Expansion in advanced NSCLCExperimental Treatment1 Intervention

Patients with Stage IV adenocarcinoma NSCLC

Group VIII: Phase 1b Dose Expansion in MSS CRCExperimental Treatment1 Intervention

Patients with histologically confirmed MSS CRC, known KRAS WT, and must have been previously treated with \> 2 lines of systemic therapy including a fluoropyrimidine, irinotecan, and/or oxaliplatin (and EGFR inhibitor if known Ras wild type)

Group IX: Phase 1b Dose Expansion in HNSCCExperimental Treatment1 Intervention

Patients with recurrent, locally advanced, or metastatic HNSCC

Group X: Phase 1b Dose Expansion in DLBCL including DLBCL-RTExperimental Treatment1 Intervention

Patients with DLBCL or DLBCL-RT, previously treated with standard, systemic chemotherapy, are not candidates for standard treatment options, or will otherwise be prevented from receiving any standard treatment options.

Group XI: Phase 1a Food EffectExperimental Treatment1 Intervention

Impact of food on NX-1607 bioavailability and tolerability to be evaluated

Group XII: Phase 1a Dose Escalation of NX-1607 in combination with PaclitaxelExperimental Treatment2 Interventions

Indications may include but are not limited to, platinum resistant EOC, gastric/GEJ cancer. HSNCC, NSCLC, TNBC, locally advanced or metastatic urothelial cancer and cervical cancer.

Group XIII: Phase 1a Dose Escalation of NX-1607 (monotherapy)Experimental Treatment1 Intervention

Multiple dose levels and dosing regimen of NX-1607 to be evaluated; determination of MTD/Phase 1b recommended dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, immunotherapy, and targeted therapy. Chemotherapy kills rapidly dividing cells, including cancer cells. Immunotherapy, such as monoclonal antibodies like rituximab, targets specific proteins on lymphoma cells, marking them for destruction by the immune system. Targeted therapies, such as kinase inhibitors, block specific molecules involved in cancer cell growth and survival. Emerging treatments like NX-1607, which is being studied for advanced malignancies, may offer new mechanisms of action by targeting specific pathways or proteins involved in cancer progression. Understanding these mechanisms is crucial for NHL patients as it helps in selecting the most effective treatment based on the specific characteristics of their lymphoma, potentially improving outcomes and minimizing side effects.