Clinical trial · Interventional
A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
A Phase I, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of SPYK04 as Monotherapy in Patients With Locally Advanced or Metastatic Solid Tumors
NCT04511845CI-TRIAL-00119835completedPhase 1ClinicalTrials.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)
Phase I, open-label, multi-center study
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 |
|---|---|---|---|
| Locally Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPYK04 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose escalation cohort of SPYK04
- description
- Patients will receive SPYK04 at escalated dose.
- interventionNames
- Drug: SPYK04
- type
- EXPERIMENTAL
- label
- Expansion part in NSCLC, ovarian cancer and other solid tumors
- description
- Patients will receive SPYK04 at the recommended dose.
- interventionNames
- Drug: SPYK04
Primary outcomes (9)
- measure
- Safety and tolerability of SPYK04 (Dose limiting toxicities) [Dose escalation]
- timeFrame
- From first dose until the end of Cycle 1 (approximately 35 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: (Both Part I and Part II) * Age \>= 18 years at time of signing informed consent form * ECOG performance status of 0 or 1 * Patients with a locally advanced, recurrent, or metastatic solid tumor for which standard therapy either does not exist or has proven ineffective or intolerable (Part I only) * Patients with measurable and/or evaluable disease per RECIST v1.1 * Patients with MAPK pathway alterations positive solid tumor (i.e., BRAF, K/N/H-RAS mutations) (Part II only) * Patients with measurable disease per RECIST v1.1 * Patients with KRAS mutated NSCLC (NSCLC cohort) * Patients with KRAS mutated Ovarian Cancer (Ovarian Cancer cohort) * Patients with RAS mutated solid tumor (Biopsy cohort) Exclusion Criteria: (Both Part I and Part II) * Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), unstable angina, or myocardial infarction within the previous 6 months or unstable arrhythmias within the previous 3 months * Patients with primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases * Patients with current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular disease, pulmonary disease, or renal disease, ongoing or active infection) * Patients with a history or complication of interstitial lung disease (ILD)
References
Publications (0)
Data not yet available
No reference posted for this study.