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
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
NCT #
NCT05162755
Condition(s)
Solid Tumors
Molecular Target(s)
None
Drug Classification(s)
human monoclonal IgG1 antibody that targets the human cell surface molecule NKG2A (CD159a) and blocks interaction with its ligand HLA-E.
Agents(s)
S095029
Phase(s)
I
Mechanism of Action
S095029 (Sym025) is a monoclonal antibody candidate against NKG2A, a receptor for natural killer cells.
Purpose
- How much of study agent 1 can be given alone and in combination with study agent 2 with an acceptable level of side effects• The effects of study agent 1 when given alone and in combination with study agent 2 (good and bad)
- How much of the study agent(s) are absorbed into the blood and how fast they are removed
- If research tests can be used in the future to predict who will benefit from the study agents
Dose escalation part:
- 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
Cohort expansion part 2a:
- Histologically proven metastatic HER2+ gastric cancer
- Have received treatment with first line of standard therapy and eligible for second line
Cohort expansion part 2b:
- Patients with confirmed adenocarcinoma of metastatic colorectal cancer
- Patients must have a wild-type gene status for KRAS (exons 2, 3, 4), NRAS (exons 2, 3, 4) and BRAF (absence of V600E mutation) in a tumor biopsy collected at time of screening.
Dose escalation part:
- 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
Cohort expansion part 2a:
- Same criteria as for Part 1 with the addition of:
- Left ventricle ejection fraction < 50% Cohort expansion part 2b: Exclusion Criteria: Same criteria as for dose escalation part with the addition of:
- Patients with a significant gastrointestinal abnormality
- Patients with skin rash of Grade > 1 from prior anti-EGFR
No restrictions
Location
MCD
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