S095029
DrugS095029 will be administered via IV infusion every 2 weeks. Once the DLT evaluations period at the second dose level is completed and it is deemed as safe, the dose escalation part 1b will be initiated.
NCT Number: NCT05162755
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Princess Margaret Cancer Centre, Toronto, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Dose escalation part:
Inclusion criteria
Exclusion criteria
S095029 will be administered via IV infusion every 2 weeks. Once the DLT evaluations period at the second dose level is completed and it is deemed as safe, the dose escalation part 1b will be initiated.
Sym021 will be administered at a fixed dose of 200mg. S095029 will be administered via IV infusion every 2 weeks. Once the RP2D dose of S95029 in combination with Sym21 is defined, dose expansion will begin.
Time frame: Through study completion, up to 2 years
Incidence, severity, and relationship of AEs
Time frame: At the end of Cycle 1 (each cycle is 28 days)
DLTs observed during a 28-day period
Time frame: Through study completion, up to 2 years
Time frame: Through study completion, up to 2 years
Assessment based on complete response, partial response and stable disease ≥ 6 months
Time frame: Through study completion, up to 2 years
Time frame: Through study completion, up to 2 years
Time frame: Through study completion, up to 2 years
Institut de Recherches Internationales Servier
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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