Clinical trial · Interventional
A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors
A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered as Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors
NCT05036291CI-TRIAL-00109114terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Development change
Summary
Brief summary (as posted)
This is a Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered as Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NB004 tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NB004
- description
- Part1: Dose escalation phase of study drug NB004 monotherapy: Part 2: Dose Escalation Phase for the NB004 in combination with Sotorasib: Part 3: COMBO Dose Expansion Phase for the NB004 in combination with Sotorasib:
- interventionNames
- Drug: NB004 tablets
Primary outcomes (8)
- measure
- Incidence of dose-limiting toxicities----Part 1/2
- timeFrame
- When subject complete 1 cycle (28 days) treatment with safety and tolerability assessment by investigators.
- description
- Dose-limiting toxicities will be reviewed as a subset of adverse events that occurs within the first 28 days of dosing and meet protocol-specified criteria.
- measure
- Incidence of adverse events----Part 1/2
- timeFrame
- Approximately 24 months since the first subject enrolled
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. males or females of any race\>(=)18 years age. 2. Histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are without standard treatment options (part 1). Pathologically confirmed locally advanced or metastatic solid tumors with KRAS G12C mutation as determined by a test that has been approved by FDA or local health authority (part 2\&3). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Life expectancy\>(=)12 weeks. 5. Adequate organ and marrow function. 6. Measurable or evaluable disease. Exclusion Criteria: 1. Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum of 3 weeks, before the first dose. 2. Toxicities from previous anti-cancer therapy that have not recovered as required. 3. Brain metastatic disease, spinal cord compression, or leptomeningeal carcinomatosis. 4. Active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV): 5. Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while in this study or within 3 months after the last dose. 6. Male subjects who plan to father a child while enrolled in the study or within 3 months after the last dose. 7. Received prior treatment with a PIM kinase inhibitor.
References
Publications (0)
Data not yet available
No reference posted for this study.