Trials / Recruiting
RecruitingNCT06147037
A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
The study will be conducted in 2 parts: Part A: optimization of the FPI-2053 dose (treatment with dose level 1 of \[225Ac\]-FPI-2068 - fixed dose). Part B: dose escalation of \[225Ac\]-FPI-2068 with optimal FPI-2053. Part B will commence once the optimal dose of FPI-2053 is determined in Part A. The RP2D will be determined from Part B based on all available safety, efficacy, PK, and dosimetry information.
Conditions
- Advanced Solid Tumor
- Metastatic Colorectal Carcinoma
- Head and Neck Squamous Cell Carcinoma
- Non-small Cell Lung Cancer
- Pancreatic Ductal Adenocarcinoma
- Gastric Cancer
- Renal Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FPI-2053 | FPI-2053 is a bispecific antibody that targets EGFR and cMET |
| DRUG | [111In]-FPI-2107 | \[111In\]-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). |
| DRUG | [225Ac]-FPI-2068 | \[225Ac\]-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. |
Timeline
- Start date
- 2024-07-31
- Primary completion
- 2028-05-12
- Completion
- 2028-05-12
- First posted
- 2023-11-27
- Last updated
- 2026-04-02
Locations
15 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06147037. Inclusion in this directory is not an endorsement.