IFNγ Helps CBLB-Deficient CD8+ T Cells to Put Up Resistance to Tregs.
Dominik Wolf, Gottfried Baier
https://pubmed.ncbi.nlm.nih.gov/35362047Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID05107674
A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a CBL-B Inhibitor, in Adults With Advanced Malignancies with Phase 1b Expansion in Select Tumor Types
Led by Nurix Therapeutics, Inc. · Updated on 2025-09-09
345
Participants Needed
17
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating NX-1607, a CBL-B inhibitor, in adults with advanced malignancies that have no effective standard treatments or for whom standard therapies are no longer suitable. This first-in-human Phase 1a/1b study aims to assess the safety, tolerability, and anti-cancer activity of NX-1607 in various solid tumors and lymphomas. The study is open-label and includes multiple cancer types such as ovarian, gastric, lung, prostate, breast, and colorectal cancers, among others. The study has two main phases: Phase 1a focuses on dose escalation to find safe and tolerable doses of NX-1607 used alone or in combination with paclitaxel. Phase 1a includes evaluation of multiple dosing levels and the effect of food on NX-1607. Phase 1b expands treatment at selected doses in specific cancers, either as monotherapy or combined with paclitaxel. Treatment involves oral NX-1607 and intravenous paclitaxel, with separate cohorts for different tumor types and dosing regimens. Participants will undergo regular assessments including safety monitoring for adverse events, immune-related effects, and dose-limiting toxicities for up to two years. Effectiveness will be measured by tumor response rates and progression-free survival over up to three years. Additional evaluations include blood tests for drug levels and biomarkers, tissue biopsies, and survival tracking. The study requires consent and adherence to protocol restrictions, with ongoing safety and efficacy monitoring throughout the study period.
CONDITIONS
Brief Title
A Study of NX-1607 in Adults With Advanced Malignancies
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Measurable metastatic or unresectable disease per specific criteria
- Disease for which standard therapy is ineffective, unavailable, or unsuitable
- ECOG performance status of 0 or 1
- Sufficient time since last systemic cancer therapy or radiotherapy as specified
- Adequate organ and bone marrow function
- Use of contraception if of child-bearing potential during study
- Ability and willingness to follow study restrictions
- Signed informed consent form
- Histological or cytological diagnosis of specified advanced malignancies
- Accessible tumor or lymph node for biopsy in Phase 1b
You will not qualify if you...
- Active untreated brain metastases
- Uncontrolled illnesses such as hypertension, diabetes, or infections requiring systemic therapy
- Primary refractory epithelial ovarian cancer
- Psychiatric illness limiting study compliance
- Recent treatment with immune checkpoint inhibitors, stem cell transplant, or certain systemic therapies within specified timeframes
- History of CAR-T therapy within 30 days
- Unresolved toxicities from prior cancer treatments except defined exceptions
- Previous severe immune-related adverse events
- History of uveitis or active autoimmune disease requiring systemic treatment in past 2 years
- Inability to swallow capsules or gastrointestinal conditions affecting drug absorption
- Known allergies or intolerance to NX-1607 components
- Pregnancy, breastfeeding, or plans for pregnancy during and shortly after study
- Recent major surgery or planned surgery during study participation
- Recent live vaccination or COVID-19 vaccination within specified periods
- Active second malignancies except certain treated cancers in remission
- HIV infection unless well controlled
- Active hepatitis infections unless resolved or controlled
- Use of systemic corticosteroids or immunosuppressive drugs within specified periods
- Use of high-dose biotin supplements
- Participation in other investigational studies or use of investigational devices within 3 weeks
- Significant cardiac events or conditions within 6 months
- Any condition or abnormality interfering with study participation or safety as judged by investigator
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - Duration varies based on dose escalation schedule
Participants receive initial dosing to evaluate safety and tolerability of NX-1607 alone or in combination with Paclitaxel.
Multiple visits during dose escalation
Treatment
Duration - Up to 3 years or until disease progression or discontinuation
Participants receive NX-1607 as monotherapy or in combination with Paclitaxel at dose levels determined in the run-in period to treat advanced malignancies.
Regular visits as per dosing schedule and monitoring requirements
Follow-up
Duration - Up to 3 years
Participants are monitored for treatment outcomes and safety after treatment completion.
Periodic visits for assessments and safety monitoring
Trial Site Locations
Total: 17 locations
1
City of Hope
Duarte, California, United States, 91010
Completed
2
University of Southern California
Los Angeles, California, United States, 90007
Actively Recruiting
3
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
4
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
Actively Recruiting
5
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
6
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
7
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
8
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
9
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
10
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
11
Royal Marsden Hospital NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
12
Addenbrookes Cambridge University Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
13
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
14
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
Actively Recruiting
15
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
16
Northern Centre for Cancer Care
Newcastle, United Kingdom, NE7 7DN
Actively Recruiting
17
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Completed
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Research Team
N
Nurix Therapeutics Patient Outreach
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
12
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