OncoMatch/Clinical Trials/NCT06147037

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

Is NCT06147037 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including FPI-2053 and [111In]-FPI-2107 for advanced solid tumor.

Phase 1RecruitingAstraZenecaNCT06147037Data as of May 2026

Treatment: FPI-2053 · [111In]-FPI-2107 · [225Ac]-FPI-2068 — 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).

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Colorectal Cancer

Head and Neck Squamous Cell Carcinoma

Non-Small Cell Lung Carcinoma

Pancreatic Cancer

Gastric Cancer

Renal Cell Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: any prior anti-cancer therapy

Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the participant refuses standard therapy.

Cannot have received: systemic radiopharmaceutical

Previous treatment with any systemic radiopharmaceutical

Cannot have received: radiation therapy

Exception: within 28 days prior to the first dose of [111In]-FPI-2107

Radiation therapy (RT) within 28 days prior to the first dose of [111In]-FPI-2107

Lab requirements

Blood counts

Kidney function

Liver function

Adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

Research Site · Irvine, California
Research Site · Palo Alto, California
Research Site · Santa Monica, California
Research Site · Chicago, Illinois
Research Site · Boston, Massachusetts

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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