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A Study of NX-1607 in Adults With Advanced Malignancies

ConditionsOvarian Cancer, EpithelialGastric CancerGastroEsophageal Junction (GEJ) CancerHead and Neck Squamous Cell CarcinomaMetastatic or Unresectable MelanomaNon-small Cell Lung Cancer (NSCLC)Metastatic Castration-resistant Prostate Cancer (mCRPC)Malignant Pleural Mesothelioma (MPM)Triple Negative Breast Cancer (TNBC)Metastatic Urothelial CarcinomaCervical CancerDiffuse Large B Cell Lymphoma (DLBCL)Richter TransformationMicrosatellite Stable Colorectal Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNurix Therapeutics, Inc.

About this trial

This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-1607 in patients with advanced malignancies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 receiving any standard treatment options.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Disqualifiers

Active untreated brain metastases.

Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension or diabetes, or ongoing active infection requiring systemic therapy.

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

Psychiatric illness that would limit compliance with study requirements.

Trial design

Design model

Sequential

Treatments tested in this trial

  • NX-1607

    Drug

    Oral NX-1607

  • Paclitaxel

    Drug

    Paclitaxel IV

Treatment groups

345 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: Phase 1a Dose Escalation of NX-1607 (monotherapy)Experimental treatment 1 intervention
Group B: Phase 1a Food EffectExperimental treatment 1 intervention
Group C: Phase 1b Dose Expansion in platinum-resistant EOCExperimental treatment 1 intervention
Group D: Phase 1b Dose Expansion in advanced gastric/GEJ cancerExperimental treatment 1 intervention
Group E: Phase 1b Dose Expansion in HNSCCExperimental treatment 1 intervention
Group F: Phase 1b Dose Expansion in recurrent melanomaExperimental treatment 1 intervention
Group G: Phase 1b Dose Expansion in advanced NSCLCExperimental treatment 1 intervention
Group H: Phase 1b Dose Expansion in mCRPCExperimental treatment 1 intervention
Group I: Phase 1b Dose Expansion in mixed solid tumor cohortExperimental treatment 1 intervention
Group J: Phase 1a Dose Escalation of NX-1607 in combination with PaclitaxelExperimental treatment 2 interventions
Group K: Phase 1b Dose Expansion of NX-1607 in combination with PaclitaxelExperimental treatment 2 interventions
Group L: Phase 1b Dose Expansion in MSS CRCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Phase 1a

Time frame
16 months
2

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

Phase 1a

Time frame
Up to 2 Years
3

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

Phase 1b

Time frame
Up to 3 Years

Secondary outcomes

1

PK parameters of NX-1607: area under the curve (AUC)

Phase 1a/1b - Sampling following the first dose, pre and post-dose at selected cycles, and at the end of treatment

Time frame
Up to 3 Years
2

PK parameters of NX-1607: apparent clearance (CL/F)

Phase 1a/1b - Sampling following the first dose, pre and post-dose at selected cycles, and at the end of treatment

Time frame
Up to 3 Years
3

PK parameters of NX-1607: maximum plasma concentration (Cmax)

Phase 1a/1b - Sampling following the first dose, pre and post-dose at selected cycles, and at the end of treatment

Time frame
Up to 3 Years
4

PK parameters of NX-1607: volume of distribution

Phase 1a/1b - Sampling following the first dose, pre and post-dose at selected cycles, and at the end of treatment

Time frame
Up to 3 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nurix Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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