Clinical trial · Interventional
Study of NKTR 255 in Combination With Cetuximab in Solid Tumors
A Phase 1b/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-255 Monotherapy or in Combination With Cetuximab as a Salvage Regimen for Solid Tumors
NCT04616196CI-TRIAL-00090768completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 1b/2, open-label multicenter study evaluating NKTR-255 as a monotherapy and together with cetuximab in patients with head and neck squamous cell carcinoma (HNSCC) and colorectal carcinoma (CRC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| NKTR-255 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation of NKTR-255 with Cetuximab
- description
- Establish RP2D, of NKTR-255 with cetuximab.
- interventionNames
- Drug: NKTR-255
- Drug: Cetuximab
Primary outcomes (2)
- measure
- Incidence of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) of NKTR-255 in Combination With Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation
- timeFrame
- 60 days after the last dose of study treatment, up to an average of 6 months.
- description
- Safety and tolerability of NKTR-255 in combination with cetuximab as evaluated by dose limiting toxicities, incidence of drug-related Adverse Events (AEs), SAEs, and AEs leading to discontinuation, deaths, and clinical laboratory abnormalities per CTCAE 5.0
- measure
- The Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of NKTR-255 in Combination With Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Histologically confirmed diagnosis of a locally advanced or metastatic HNSCC or CRC. * Life expectancy \> 12 weeks as determined by the Investigator. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Measurable disease per RECIST 1.1. HNSCC: * Progression on any first or second line platinum-based chemotherapy and/or anti-PD-1 or programmed death-ligand 1 antibody. CRC: * Patients must have received or were intolerant to at least 2 prior cancer therapy regimens administered for metastatic disease. Key Exclusion Criteria: * Use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug(s) * Prior surgery or radiotherapy within 14 days of initiating study drug(s) * Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis; active infection requiring systemic therapy within 7 days prior to dosing * Patients who have been previously treated with IL-2 or IL-15 * Known Grade 3 or 4 hypersensitivity reaction to cetuximab, history of allergy to red meat or tick bites, or history of positive test results for immunoglobulin E antibodies against cetuximab * Patients who have an active, known, or suspected autoimmune disease NOTE: Other protocol defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.