Clinical trial NCT05162755: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Keywords: Adults
Advanced solid tumors
Sym21
Futuximab/modotuximab
Triplet combination
Anti-EGFR
Anti-HER2
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: ADIR, a Servier Group company
First posted: 2021-12-17
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events (AEs) (Dose escalation part)
timeFrame: Through study completion, up to 2 years
measure: Incidence of dose limiting toxicities (DLTs) (Dose escalation part)
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Through study completion, up to 2 years
measure: Clinical Benefit Rate (CBR)
timeFrame: Through study completion, up to 2 years
measure: Duration of response (DOR)
timeFrame: Through study completion, up to 2 years
measure: Progression Free Survival (PFS)
timeFrame: Through study completion, up to 2 years
measure: Overall Survival (OS)
timeFrame: Through study completion, up to 2 years
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: The START Center for Cancer Care
state: Texas
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
Study officials:
affiliation: Director of Clinical Research START Midwest
name: Nehal Lakhani MD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: