Advanced Cancer, Metastatic Cancer
Conditions
Keywords
Immuno-oncology, Bispecific antibody, Dose escalation, Cohort expansion, OX40, CD137 (4-1BB), invoX, Pembrolizumab, PD-1
Brief summary
This is a Phase 1/1b, multicenter, open label study to evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination with Pembrolizumab, in Subjects with Advanced Malignancies
Interventions
DRUGFS120
Dosing of participants with FS120 or the combination pembrolizumab will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) or once every 3 weeks (Q3W) until confirmed progressive disease (CPD)/immune-confirmed progressive disease (iCPD) or unacceptable toxicity.
Sponsors
Merck Sharp & Dohme LLC
invoX Pharma Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Measurable disease * Eastern Cooperative Oncology Group Performance Status 0-1. * Highly effective contraception if risk of conception exists * A female subject is eligible if not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or is a WOCBP that uses highly effective contraception * Subjects with HIV who are healthy and how a low risk of acquired immunodeficiency syndrome related outcomes * For combination part: Subjects must have histologically confirmed locally advanced, unresectable or metastatic solid tumours where there is regulatory approval for use of pembrolizumab as a monotherapy agent
Exclusion criteria
* Prior systemic anticancer therapy within 28 days or 5- half-lives, whichever is shorter, before the first dose of study drug. * Prior therapy with any OX40 agonist, CD137 (4-1BB) agonist, CD40 agonist, GITR, or CD27 targeting therapy (single agent or combination). * Prior radiotherapy within 2 weeks of start of study treatment. * HIV infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease. * Uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis, primary CNS tumours, or solid tumours with CNS metastases as the only measurable disease. * Prior history of any grade ≥3 immune-related AE (irAE) that has not improved to grade ≤1; any grade ≥3 irAE that resulted in discontinuation of treatment, significant (grade ≥3 NCI CTCAE Version 5.0) treatment-related cytokine release syndrome. * Use of immunosuppressive agents, hypersensitivity or intolerance to monoclonal antibodies or their excipients, persistent grade ≥1 NCI CTCAE Version 5 toxicity related to prior therapy or any condition that would significantly impair and/or prohibit the participant's participation in the study, as per the investigator's judgement. * Vaccination with a live vaccine within 30 days before first dose of study drug. * Participants with a known additional malignancy that is progressing or has required active treatment in the past 3 years. * Participants with severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs) | 24 months | Safety and tolerability will be evaluated by collection of AEs, SAEs and DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. |
| Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) | 24 months | Toxicity will be evaluated according to the NCI CTCAE Version 5.0. |
Countries
Spain, United States
Outcome results
None listed