Clinical trial · Interventional
S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers
A Phase 1a/1b, Open-label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Anti-neoplastic Activity of S095029 (Anti-NKG2A) as Monotherapy and in Combination With Sym021 (Anti-PD-1) in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triplet Combinations of S095029 and Sym021 and an Anti-HER2 mAb or Anti-EGFR mAbs (Futuximab/Modotuximab) in Patients With Metastatic Gastric or Colorectal Cancers
- 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)
The purpose of the study is to investigate the safety, tolerability, and preliminary anti-neoplastic activity of S095029 alone and in combination with Sym021 in patients with advanced solid tumor malignancies followed by an expansion phase of triple combinations. \*The study sponsor has made the decision not to move forward to the expansion part of the study due to strategic considerations, unrelated to any safety issues or concerns. The study will be stopped after completion of dose escalation parts 1a and 1b of the 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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S095029 | Drug | — | UNRESOLVED |
| S95029 and Sym021 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose escalation 1a: S95029
- interventionNames
- Drug: S095029
- type
- EXPERIMENTAL
- label
- Dose escalation 1b: S95029 and Sym021
- interventionNames
- Drug: S95029 and Sym021
Primary outcomes (2)
- measure
- Adverse Events (AEs) (Dose escalation part)
- timeFrame
- Through study completion, up to 2 years
- description
- Incidence, severity, and relationship of AEs
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Dose escalation part: Inclusion Criteria: * Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumor malignancies * Patients with a malignancy not amenable to surgical intervention * Patients with measurable disease and progression radiologically assessed * Patients with disease progression after treatment with available standard of care therapies that are known to confer clinical benefit or who are intolerant to treatment. * Patients with available archived tumor biopsy specimens or agree to mandatory biopsy * Estimated life expectancy ≥ 12 weeks * Adequate haematological function * Adequate renal function * Adequate hepatic function Exclusion Criteria: * Pregnant and lactating women * Major surgery within 4 weeks prior to the first IMP administration or not recovered from the surgery * Patients with serious/active/uncontrolled infection or infection requiring parenteral antibiotics, within 2 weeks prior to first IMP administration * Active Hepatitis B Virus infection * Carriers of HIV antibodies * Patients with active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to first IMP administration * History of organ transplantation * History of gastrointestinal perforation, or intra-abdominal abscess within 28 days of inclusion * History of cirrhosis * History of pulmonary fibrosis or relevant uncontrolled chronic pulmonary condition * Treatment with systemic immunosuppressive therapy * Active autoimmune disease * Administration of a live vaccine within 28 days prior to inclusion
References
Publications (1)
- DERIVEDNaing A, Spreafico A, Barve M, Patnaik A, Ianopoulos X, Drean P, Skartved NJ, Hemon A, Kantari-Mimoun C, He P, Askoxylakis V, Lakhani N. Phase 1 multicenter study of the NKG2A targeting antibody S095029 as a single agent and in combination with anti-PD-1 in patients with advanced malignancies. J Immunother Cancer. 2026 May 8;14(5):e014325. doi: 10.1136/jitc-2025-014325. PMID 42103356