A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

Part of paid clinical trials in Irvine, California.

Sponsor
AstraZeneca
Study ID
NCT06147037
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • FPI-2053 — DRUG
    FPI-2053 is a bispecific antibody that targets EGFR and cMET
  • [111In]-FPI-2107 — DRUG
    \[111In\]-FPI-2107 is an imaging agent in which indium-111 is conjugated to FPI-2053. Participants will have a fixed dose of \[111In\]-FPI-2107 followed by imaging scans (with or without pre-administration of FPI-2053).
  • [225Ac]-FPI-2068 — DRUG
    \[225Ac\]-FPI-2068 is a radiopharmaceutical therapy in which an alpha emitter, actinium-225, is conjugated to FPI-2053. Participants will be dosed through IV administration every 56 days for up to 3 cycles of the Treatment Period.

Study Details

This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of \[225Ac\]-FPI-2068, \[111In\]-FPI-2107, and FPI-2053 in metastatic and/or recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC, GC, RCC).

Key Dates

Start date
Jul 31, 2024
Status verified
May 2026
Primary completion
May 12, 2028
Completion
May 12, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Exploration and Dose Escalation
    The study conducted in two parts: Part A Dose Exploration and Part B Dose Escalation FPI-2053 dose exploration to determine the optimal pre-dose administration of FPI-2053 with a fixed dose of \[225Ac\]-FPI-2068. \[225Ac\]-FPI-2068 dose escalation with the optimal dose of FPI-2053 as determined in Part A.

Primary Outcome Measure

Evaluate safety and tolerability of [111In]-FPI-2107, FPI-2053, and [225Ac]-FPI-2068 [ Time Frame: From informed consent up to approximately 5 years post last administration ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Research SiteIrvineCalifornia92618-
Research SitePalo AltoCalifornia94304-
Research SiteSanta MonicaCalifornia90404-
Research SiteChicagoIllinois60637-
Research SiteBostonMassachusetts02215-
Research SiteSt LouisMissouri63110-
Research SiteOmahaNebraska68130-
Research SiteClevelandOhio44195-
Research SitePittsburghPennsylvania15237-
Research SiteHoustonTexas77030-
Research SiteSeattleWashington98109-

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