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

CL1-95029-001

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.

2021-10-15

2024-02-01

2024-07-31

Active (not recruiting)

Early phase I

51

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 Cohort expansion part 2a: Inclusion Criteria: * Histologically proven metastatic HER2+ gastric cancer * Have received treatment with first line of standard therapy and eligible for second line Exclusion Criteria: Same criteria as for Part 1 with the addition of: - Left ventricle ejection fraction \< 50% Cohort expansion part 2b: Inclusion Criteria: * 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. 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

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2024-04-09