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NX-1607

Phase 1

Ovarian Cancer, Epithelial | Small molecule | Oncology |Nurix Therapeutics, Inc.|Trials Updated: Sep 9, 2025

NX-1607 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2021

NX-1607 target and mechanism

Molecular targetCBL-B
ModalitySmall molecule

Also known as Cbl-b Inhibitor

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment345

FDA Designations

No designations recorded

NX-1607 clinical trials

NX-1607 · 1 trial · 14 indications

Phase 1 1
NCT05107674A Study of NX-1607 in Adults With Advanced MalignanciesOvarian Cancer, Epithelial
RECRUITING345 Analytics
PHASE1RECRUITING
A Study of NX-1607 in Adults With Advanced Malignancies
Ovarian Cancer, EpithelialUnlock trial analytics

Study Endpoints

Primary Endpoints

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
16 months

Phase 1a

Incidence of immune-related AEs (irAEs), all deaths, and dose-limiting toxicities (DLTs)
Up to 2 Years

Phase 1a

Objective Response Rate (ORR) per disease-specific response criteria as assessed by the Investigator
Up to 3 Years

Phase 1b

Secondary Endpoints

PK parameters of NX-1607: area under the curve (AUC)
Up to 3 Years
PK parameters of NX-1607: apparent clearance (CL/F)
Up to 3 Years
PK parameters of NX-1607: maximum plasma concentration (Cmax)
Up to 3 Years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1a Dose Escalation of NX-1607 (monotherapy)EXPERIMENTALMultiple dose levels and dosing regimen of NX-1607 to be evaluated; determination of MTD/Phase 1b recommended dose.
Phase 1a Food EffectEXPERIMENTALImpact of food on NX-1607 bioavailability and tolerability to be evaluated
Phase 1b Dose Expansion in platinum-resistant EOCEXPERIMENTALPatients with platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma
Phase 1b Dose Expansion in advanced gastric/GEJ cancerEXPERIMENTALPatients with recurrent, locally advanced, or metastatic gastric or GEJ adenocarcinoma
Phase 1b Dose Expansion in HNSCCEXPERIMENTALPatients with recurrent, locally advanced, or metastatic HNSCC
Phase 1b Dose Expansion in recurrent melanomaEXPERIMENTALPatients with recurrent and either metastatic or unresectable Melanoma
Phase 1b Dose Expansion in advanced NSCLCEXPERIMENTALPatients with Stage IV NSCLC
Phase 1b Dose Expansion in mCRPCEXPERIMENTALPatients 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
Phase 1b Dose Expansion in mixed solid tumor cohortEXPERIMENTALCohort of mixed solid tumor indications consisting of patients with MPM, TNBC, locally advanced or metastatic urothelial cancer, cervical cancer, or DLBCL/DLBCL-RT
Phase 1a Dose Escalation of NX-1607 in combination with PaclitaxelEXPERIMENTALIndications 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.
Phase 1b Dose Expansion of NX-1607 in combination with PaclitaxelEXPERIMENTALIndications may include but are not limited to, platinum resistant EOC, gastric/GEJ cancer, HSNCC, NSCLC, TNBC, and locally advanced or metastatic urothelial cancer and cervical cancer
Phase 1b Dose Expansion in MSS CRCEXPERIMENTALPatients 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)

Interventions

NameTypeDescription
NX-1607DRUGOral NX-1607
PaclitaxelDRUGPaclitaxel IV
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Key Inclusion Criteria: * Age ≥ 18 years. * Measurable disease per disease-specific response criteria. * Patients must have disease that is metastatic or unresectable and have received standard treatment options, are not candidates for standard treatment options, or will otherwise be prevented from...

Countries:United StatesUnited Kingdom
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Frequently asked questions about NX-1607

What is NX-1607?

NX-1607 is an investigational small molecule drug being developed by Nurix Therapeutics, Inc. for the treatment of advanced cancers, including epithelial ovarian cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA. It is being studied in adults with advanced malignancies.

What is NX-1607 used for?

NX-1607 is being studied for the treatment of advanced solid tumors and blood cancers, including epithelial ovarian cancer, gastric cancer, gastroesophageal junction cancer, head and neck squamous cell carcinoma, melanoma, non-small cell lung cancer, metastatic castration-resistant prostate cancer, malignant pleural mesothelioma, triple negative breast cancer, metastatic urothelial carcinoma, cervical cancer, diffuse large B cell lymphoma, Richter transformation, and microsatellite stable colorectal carcinoma.

What does NX-1607 target?

NX-1607 targets CBL-B, an E3 ubiquitin ligase that acts as a negative regulator of immune cell activation. By inhibiting CBL-B, NX-1607 is designed to enhance T-cell and natural killer cell activation against tumor cells. This mechanism is intended to boost the body's immune response to cancer.

Who makes NX-1607?

NX-1607 is being developed by Nurix Therapeutics, Inc., a biopharmaceutical company focused on targeted protein degradation and modulation. Nurix Therapeutics trades on the Nasdaq under the ticker symbol NRIX. The company is the sponsor of the ongoing Phase 1 clinical trial evaluating NX-1607 in patients with advanced malignancies.

What phase is NX-1607 in?

NX-1607 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 trial is currently recruiting participants and is designed to evaluate the safety, tolerability, and preliminary activity of NX-1607 in adults with advanced cancers.

What clinical trials is NX-1607 in?

NX-1607 is being evaluated in a Phase 1 clinical trial, NCT05107674, titled A Study of NX-1607 in Adults With Advanced Malignancies. The trial is currently recruiting and has an estimated enrollment of 345 participants. It is being conducted in the United States and the United Kingdom and includes patients with a range of advanced solid tumors and lymphomas.