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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial studies a new cancer drug to see if it's safe and has anti-cancer activity in people with advanced cancer.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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
~5380
Find a Location
Who is running the clinical trial?
Nurix Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
502 Total Patients Enrolled
Paula O'Connor, MDStudy DirectorNurix Therapeutics, Inc.
3 Previous Clinical Trials
459 Total Patients Enrolled
Robert J BrownStudy DirectorNurix Therapeutics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a live vaccine in the last 28 days or a COVID-19 vaccine in the last 14 days.I cannot take pills by mouth or have serious digestive system issues.My cancer has spread or can't be removed and I've tried, can't have, or can't get standard treatments.I haven't had major surgery in the last 4 weeks and don't plan any during the study.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.It's been enough time since my last cancer treatment.I haven't had certain cancer treatments or drugs recently before starting NX-1607.I can have a biopsy on my tumor or lymph node (if I have DLBCL).My ovarian cancer did not respond to the first platinum-based treatment or came back within 6 months.I have not had CAR-T therapy in the last 30 days.I am 18 years old or older.My side effects from past cancer treatments are mild, except for hair loss and some nerve pain.I had severe side effects from previous immunotherapy.I am a man planning to father a child soon and will be taking NX-1607 or paclitaxel.I have brain metastases that haven't been treated.My organs and bone marrow are functioning well without needing extra help.My cancer is resistant to platinum-based treatments.I am fully active or restricted in physically strenuous activity but can do light work.I do not have any uncontrolled illnesses like high blood pressure, diabetes, or infections needing treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b Dose Expansion in DLBCL including DLBCL-RT
- Group 2: Phase 1a Dose Escalation of NX-1607 (monotherapy)
- Group 3: Phase 1b Dose Expansion in advanced NSCLC
- Group 4: Phase 1b Dose Expansion in recurrent melanoma
- Group 5: Phase 1a Dose Escalation of NX-1607 in combination with Paclitaxel
- Group 6: Phase 1b Dose Expansion of NX-1607 in combination with Paclitaxel
- Group 7: Phase 1b Dose Expansion in mixed solid tumor cohort
- Group 8: Phase 1b Dose Expansion in platinum-resistant EOC
- Group 9: Phase 1b Dose Expansion in HNSCC
- Group 10: Phase 1b Dose Expansion in MSS CRC
- Group 11: Phase 1b Dose Expansion in mCRPC
- Group 12: Phase 1b Dose Expansion in advanced gastric/GEJ cancer
- Group 13: Phase 1a Food Effect
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks may be incurred when undergoing Phase 1b Dose Expansion in platinum-resistant EOC?
"Due to the limited data surrounding its efficacy and safety, Phase 1b Dose Expansion in platinum-resistant EOC was assigned a score of 1."
Answered by AI
Are there open spots available for enrolment in this clinical trial?
"Per the information on clinicaltrials.gov, this study is actively seeking participants. It was initially advertised on September 29th 2021 and recently amended as of March 20th 2023."
Answered by AI
What is the scope of patient participation in this clinical investigation?
"Affirmative. The information on clinicaltrials.gov demonstrates that this research is still in the process of recruiting patients, having been first posted on September 29th 2021 and updated most recently on March 20th 2023. 268 individuals are sought-after from 8 distinct sites."
Answered by AI
How many facilities are actively monitoring this research?
"This trial is recruiting from 8 distinct locations, including University College London Hospitals NHS Foundation Trust in Bloomsbury, Sarah Cannon Research Institute in London and The Christie NHS Foundation Trust in Manchester. Additionally there are 5 other sites involved with the study."
Answered by AI
What are the chief aims of this trial?
"The primary outcome of the study sponsored by Nurix Therapeutics, Inc., will be monitored over 16 months. This includes tracking the number of immune-related adverse events (irAEs), fatalities and dose-limiting toxicities (DLTs). Additionally, investigators shall also measure secondary effects such as disease control rate (DCR) for phase 1a/1b cohorts, time to disease progression according to relevant histology in phase 1b groups; finally overall survival (OS) for both phase 1a/1b cohorts."
Answered by AI
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