FS120 Phase 1/1b Study in Patients With Advanced Malignancies

A Phase 1/1b 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

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

Study Overview

• Status: Recruiting
• Conditions: Metastatic Cancer; Advanced Cancer
• Intervention / Treatment: Drug: FS120

• Study Type: Interventional
• Enrollment (Estimated): 277
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: invoX Clinical Trials; Phone Number: +44 2038 820886; Email: info@invoxpharma.com

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall d'Hebron
    • Contact: Enriqueta Felip Font, Ldo.
  • Barcelona, Spain, 08023
    • Recruiting
    • NEXT Oncology, Hospital Quironsalud Barcelona
    • Contact: Fabricio Racca, MD
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
    • Contact: Guillermo De Velasco Oria De Rueda, Ldo.
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Fundación Jiménez Díaz
    • Contact: Victor Moreno, Ldo.
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clínico Universitario de Valencia
    • Contact: Andrés Cervantes Ruiperez, Ldo.
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Completed
      • Yale University
  • Texas
    • Houston, Texas, United States, 77030
      • Completed
      • MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • South Texas Accelerated Research Therapeutics (START)
      • Contact: Kyriakos Papadopoulos, MD
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Huntsman Cancer Institute, University of Utah
      • Contact: Siwen Hu-Lieskovan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FS120; Open-label study where FS120 will be administered as monotherapy or in combination with pembrolizumab in dose escalation and expansion cohorts	Drug: FS120; 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.; Other Names: Pembrolizumab (KEYTRUDA®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs)	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.	24 months
Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)	Toxicity will be evaluated according to the NCI CTCAE Version 5.0.	24 months

Collaborators and Investigators

• Sponsor: invoX Pharma Limited
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pembrolizumab; Dose escalation; PD-1; OX40; Immuno-oncology; Bispecific antibody; Cohort expansion; CD137 (4-1BB); invoX
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Pembrolizumab
• Other Study ID Numbers: FS120-19101; 2021-002820-19 (EudraCT Number); MK-3475-C82 (Other Identifier: Merck Sharp & Dohme LLC); KEYNOTE-C82 (Other Identifier: Merck Sharp & Dohme LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No