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A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours

F

Fusion Pharmaceuticals

Status and phase

Enrolling
Phase 1

Conditions

NTSR1 Expressing Solid Tumours
Gastric Cancer
Neuroendocrine Differentiated (NED) Prostate Cancer
Squamous Cell Carcinoma of Head and Neck
Pancreatic Ductal Adenocarcinoma (PDAC)
Ewing Sarcoma
Colorectal Cancer

Treatments

Drug: [225]-FPI-2059
Drug: [111In]-FPI-2058

Study type

Interventional

Funder types

Industry

Identifiers

NCT05605522
FPI-2059-101

Details and patient eligibility

About

This is a first-in-human Phase 1 clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and biodistribution of [225Ac]-FPI-2059 and [111In]-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid tumours.

Full description

This is a first-in-human, Phase 1, non-randomized, multi-centre, open-label clinical trial designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2058, as well as the pharmacodynamics and preliminary anti-tumour activity of [225Ac]-FPI-2059 in participants with neurotensin receptor 1 (NTSR1)-expressing advanced, metastatic and/or recurrent solid tumours.

The study will employ a 3+3 dose escalation design to identify the recommended phase 2 dose (RP2D) and regimen of [225Ac]-FPI-2059 administered intravenously every 56 days.

After the RP2D for [225Ac]-FPI-2059 is determined, enrolment will continue into an expansion cohort, to confirm the safety and tolerability of the RP2D, as well as to identify any preliminary evidence of efficacy in selected NTSR1-expressing tumour types.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Signed ICF prior to initiation of any study-specific procedures
  • Histologically and/or cytologically confirmed solid tumor that is metastatic or locally advanced, inoperable, or recurrent. Solid tumors indications may include PDAC, CRC, NED prostate cancer, gastric cancer, SCCHN, and Ewing sarcoma.
  • Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the patient refuses standard therapy
  • Measurable disease per RECIST v.1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Sufficient target expression in at least one measurable lesion as determined by imaging following injection of [111In]-FPI-2058
  • Adequate organ function
  • Tumor tissue (either archival within the last 24 months or fresh biopsy)

Key Exclusion Criteria:

  • Previous treatment with any radiopharmaceutical
  • Contraindications to or inability to perform the imaging procedures required in this study
  • Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents within certain amount of time prior to administration of the first dose of [111In]-FPI-2058
  • Radiation therapy (RT) within 28 days prior to the first dose of [111In]-FPI-2058
  • Patients with known CNS metastatic disease
  • Concurrent severe and/or uncontrolled illness that would limit compliance with study requirements
  • Known or suspected allergies or contraindication to the investigational treatment
  • Received any type of vaccine within 30 days prior to the first dose of [111In]-FPI-2058

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

42 participants in 2 patient groups

Phase 1 Dose Escalation
Experimental group
Treatment:
Drug: [111In]-FPI-2058
Drug: [225]-FPI-2059
Phase 1 Dose Expansion
Experimental group
Treatment:
Drug: [111In]-FPI-2058
Drug: [225]-FPI-2059

Trial contacts and locations

8

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Central trial contact

Clinical Trials Fusion Pharmaceuticals

Data sourced from clinicaltrials.gov

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