Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by Thomas Hope (ucsf)

Description

Summary

Phase 1 of this study will evaluate the safety and tolerability of 177Lu-FAP-2286 and determine the recommended Phase 2 dose (RP2D) in patients with advanced solid tumors. Phase 2 of this study is designed to evaluate objective response rate (ORR) in patients with specific solid tumors.

Official Title

LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of 177Lu-FAP-2286 in Patients With an Advanced Solid Tumor

Keywords

Solid Tumor 177Lu-FAP-2286 68Ga-FAP-2286 theranostic FAP-2286 FAP fibroblast activation protein dosimetry CAF cancer-associated fibroblasts Peptide-Targeted Radioligand Therapy PTRT Peptide Receptor RadionuclideTherapy PRRT TRT Targeted radioligand therapy Target radionuclide therapy Lutetium-177 Gallium-68 Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  • Be ≥ 18 years of age at the time the ICF is signed.
  • Consent to submission of archival tumor tissue, if available.
  • Adequate bone marrow, hepatic, and renal function.
  • ECOG performance status of 0 or 1.
  • Life expectancy of at least 6 months.
  • Measurable disease per RECIST v1.1.

Phase 1 only:

• Patients must have an advanced/metastatic solid tumor that is refractory to or has progressed following prior treatment and has no satisfactory alternative treatment options.

Patient enrolled in Phase 2 will have one of several specific tumor types with advanced or recurrent or metastatic disease following prior therapy.

You CAN'T join if...

  • Active second malignancy that may interfere with the safety or efficacy assessments of this study
  • Symptomatic and/or untreated central nervous system (CNS) metastases or leptomeningeal disease or with primary tumor of CNS origin. Patients must be clinically stable for at least 4 weeks without steroid treatment
  • Received anticancer treatment ≤ 14 days prior to receiving study treatment (≤ 28 days prior in case of checkpoint inhibitor or other antibody therapies)
  • Received prior radiopharmaceutical therapy or radioembolization, or prior extensive external beam radiation therapy (EBRT) to bone marrow or any prior EBRT to kidney, or received any EBRT within 2 weeks prior to administration of study treatment
  • Ongoing adverse effects from anticancer treatment > Grade 1, with the exception of alopecia
  • Known incompatibility with contrast media for CT or PET scans. Infection requiring systemic antibiotics within 2 weeks prior to administration of study treatment
  • Impaired cardiac function or clinically significant cardiac disease
  • Severe urinary incontinence, voiding dysfunction, or urinary obstruction
  • Minor surgery ≤ 5 days, or major surgery ≤ 21 days, prior to administration of study treatment.
  • Any other condition that may increase the risk associated with study participation or interfere with its interpretation.
  • Refusal to use highly effective method of contraception, as applicable
  • Pregnant or breastfeeding
  • Any other condition that may increase the risk associated with study participation or interfere with its interpretation.

Locations

  • UCSF Medical Center not yet accepting patients
    San Francisco California 94158 United States
  • University of Texas MD Anderson Cancer Center not yet accepting patients
    Houston Texas 77030 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Clovis Oncology, Inc.
ID
NCT04939610
Phase
Phase 1/2
Study Type
Interventional
Last Updated