Solid Tumor
Conditions
Keywords
Adults, Advanced solid tumors, Sym21, Futuximab/modotuximab, Triplet combination, Anti-EGFR, Anti-HER2
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.
Interventions
DRUGS095029
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.
DRUGS95029 and Sym021
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.
Sponsors
Institut de Recherches Internationales Servier
ADIR, a Servier Group company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) (Dose escalation part) | Through study completion, up to 2 years | Incidence, severity, and relationship of AEs |
| Incidence of dose limiting toxicities (DLTs) (Dose escalation part) | At the end of Cycle 1 (each cycle is 28 days) | DLTs observed during a 28-day period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | Through study completion, up to 2 years | — |
| Clinical Benefit Rate (CBR) | Through study completion, up to 2 years | Assessment based on complete response, partial response and stable disease ≥ 6 months |
| Duration of response (DOR) | Through study completion, up to 2 years | — |
| Progression Free Survival (PFS) | Through study completion, up to 2 years | — |
| Overall Survival (OS) | Through study completion, up to 2 years | — |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORNehal Lakhani MD, MD, PhD
Director of Clinical Research START Midwest
Outcome results
None listed