Clinical trial · Interventional
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer
- 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 clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.
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 Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FLX475 (tivumecirnon) | Drug | — | UNRESOLVED |
| pembrolizumab (KEYTRUDA®) | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1a: Monotherapy Dose Escalation
- description
- Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy.
- interventionNames
- Drug: FLX475 (tivumecirnon)
- type
- EXPERIMENTAL
- label
- Part 1b: Combination Dose Escalation
- description
- Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 in combination with pembrolizumab.
- interventionNames
- Drug: FLX475 (tivumecirnon)
- Drug: pembrolizumab (KEYTRUDA®)
- type
- EXPERIMENTAL
- label
- Part 2a: Monotherapy Expansion Cohorts
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented advanced or metastatic cancer ineligible for standard therapies with one of the following histologies * Dose Escalation: non-small cell lung cancer, head and neck squamous cell carcinoma, nasopharyngeal carcinoma, metastatic triple negative breast cancer, urothelial carcinoma, gastric cancer, esophageal carcinoma, cervical cancer, classical Hodgkin lymphoma * Dose Expansion: nasopharyngeal carcinoma, lymphoma, head and neck squamous cell carcinoma, cervical cancer, non-small cell lung cancer, triple-negative breast cancer * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Evaluable disease at baseline (at least one measurable target lesion by imaging for expansion cohorts) * Tumor available for biopsy Exclusion Criteria: * History of allergy or severe hypersensitivity to biologic agents * History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immuno-oncology treatment * Active autoimmune disease or serious autoimmune disease within past 2 years requiring systemic therapy * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required steroids, or symptoms of active pneumonitis * Prior allogeneic hematopoietic stem cell transplant within 5 years, or prior allogeneic organ transplant * Active graft-versus-host disease
References
Publications (0)
Data not yet available