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

NCT04648202 | Active Not Recruiting Phase 1 FDA Drug

• 4 other identifiers: FS120-191012021-002820-19MK-3475-C82KEYNOTE-C82
• Study Type: interventional
• Target: 82
• Locations: 2 countries
• Sites: 9

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

Conditions

Advanced Cancer; Metastatic Cancer

Keywords

Immuno-oncology; Bispecific antibody; Dose escalation; Cohort expansion; OX40; CD137 (4-1BB); invoX; Pembrolizumab; PD-1

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

FS120

EXPERIMENTAL

Open-label study where FS120 will be administered as monotherapy or in combination with pembrolizumab in dose escalation and expansion cohorts

Drug: FS120

Interventions

FS120 DRUG

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.

Also known as: Pembrolizumab (KEYTRUDA®)

FS120

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• invoX Pharma Limited: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (9)

Yale University

New Haven, Connecticut, 06511, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229, United States

Location

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

Location

NEXT Oncology, Hospital Quironsalud Barcelona

Barcelona, 08023, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 1, 2020
• Study Start: November 18, 2020
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2024-10

Locations

US (4); ES (5)