A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
Phase 1 trial tests new targeted radiation therapy for advanced solid tumors
Plain English Summary
A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours is a Phase 1 clinical trial sponsored by AstraZeneca studying 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. This study is testing a new drug called [225Ac]-FPI-2068, which is a type of targeted radiation therapy, along with an imaging agent and another drug called FPI-2053. It is for adults with advanced solid tumors that have spread or cannot be removed by surgery, and for whom standard treatments are no longer working or are not suitable. Participants will receive the study drugs through an IV, and will undergo imaging scans. The study involves dose escalation to find the right dose. There are no standard alternatives being tested in this trial; patients may have already tried other treatments. The trial aims to enroll 70 participants.
Official 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).
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with specific types of advanced solid tumors that have spread or cannot be removed by surgery. Patients whose cancer has progressed despite previous treatments and for whom no other effective standard therapy is available or suitable. Must have measurable disease and a good general health status (ECOG 0 or 1). Cannot have received previous treatment with other radiopharmaceuticals, have certain other medical conditions, or have untreated brain metastases. This trial is studying 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, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcomes measure how safe and well-tolerated the study drugs are, and to determine the correct dose of the radiation therapy, ensuring it can be given safely to patients. The specific primary outcome measures are: Evaluate safety and tolerability of [111In]-FPI-2107, FPI-2053, and [225Ac]-FPI-2068 (From informed consent up to approximately 5 years post last administration); Determine radiation dose of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest. (Within 56 days of administration); Determine the RP2D of [225Ac]-FPI-2068, given with or without FPI-2053 (56 days post administration); Determine the effect of predose administration of varying doses of FPI-2053 on the radiation dosimetry of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest. (56 days post-administration). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial is important because it explores a novel targeted radiation therapy that aims to deliver cancer-killing radiation directly to tumor cells, potentially offering a new treatment option for pa This research targets 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, where improved treatment options are needed.
Investor Insight
This Phase 1 trial represents an early-stage investment in a novel radiopharmaceutical therapy platform targeting common and difficult-to-treat solid tumors, with potential for significant market impa Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the specific type of cancer you have and if it matches the types being studied. Understand that this is a dose-escalation study, meaning the dose of the radiation therapy will be carefully increased to find the safest and most effective level. Participation involves regular clinic visits for drug administration, imaging scans, and monitoring for side effects over several years. This trial is currently recruiting participants. The trial is being conducted at 15 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: SEQUENTIAL
- Masking: NONE
- Enrollment: 70 participants
Interventions
- 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.
Primary Outcomes
- Evaluate safety and tolerability of [111In]-FPI-2107, FPI-2053, and [225Ac]-FPI-2068 (From informed consent up to approximately 5 years post last administration)
- Determine radiation dose of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest. (Within 56 days of administration)
- Determine the RP2D of [225Ac]-FPI-2068, given with or without FPI-2053 (56 days post administration)
- Determine the effect of predose administration of varying doses of FPI-2053 on the radiation dosimetry of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest. (56 days post-administration)
Secondary Outcomes
- Assess preliminary anti-tumor activity of [225Ac]-FPI-2068 (Approximately 5 years post final administration)
- Tumor uptake of [111In]-FPI-2107 (Within 56 days of administration)
- Pharmacokinetics (PK) of [111In]-FPI-2107, and [225Ac]-FPI-2068, by measuring changes in clearance, AUC, Cmax, and half-life. (From first dose of investigation product until 56 days after the last dose of investigational product.)
- To assess the immunogenicity of [111In]-FPI-2107, [225Ac]-FPI-2068, and FPI-2053 (From first dose of investigation product until 56 days after the last dose of investigational product.)
Full Eligibility Criteria
Key Inclusion Criteria: Histologically and/or cytologically confirmed solid tumor that is metastatic, locally advanced, recurrent or inoperable. 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. Measurable disease as defined by RECIST Version 1.1 ECOG Performance status of 0 or 1 Adequate organ function Key Exclusion Criteria: Previous treatment with any systemic radiopharmaceutical Prior anti-cancer therapy unless adequate washout and recovery from toxicities Contraindications to or inability to perform the imaging procedures required in this study Radiation therapy (RT) within 28 days prior to the first dose of \[111In\]-FPI-2107 Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month) Patients with known CNS metastatic disease unless treated and stable
Trial Locations
- Research Site, Irvine, California, United States
- Research Site, Palo Alto, California, United States
- Research Site, Santa Monica, California, United States
- Research Site, Chicago, Illinois, United States
- Research Site, Boston, Massachusetts, United States
- Research Site, St Louis, Missouri, United States
- Research Site, Omaha, Nebraska, United States
- Research Site, Cleveland, Ohio, United States
- Research Site, Pittsburgh, Pennsylvania, United States
- Research Site, Houston, Texas, United States
- ...and 5 more locations
Frequently Asked Questions
What is clinical trial NCT06147037?
NCT06147037 is a Phase 1 INTERVENTIONAL study titled "A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours." It is currently recruiting and is sponsored by AstraZeneca. The trial targets enrollment of 70 participants.
What conditions does NCT06147037 study?
This trial investigates treatments for 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. The primary condition under study is Advanced Solid Tumor.
What treatments are being tested in NCT06147037?
The interventions being studied include: FPI-2053 (DRUG), [111In]-FPI-2107 (DRUG), [225Ac]-FPI-2068 (DRUG). FPI-2053 is a bispecific antibody that targets EGFR and cMET
What does Phase 1 mean for NCT06147037?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT06147037?
This trial is currently "Recruiting." It started on 2024-07-31. The estimated completion date is 2028-05-12.
Who is sponsoring NCT06147037?
NCT06147037 is sponsored by AstraZeneca. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06147037?
The trial aims to enroll 70 participants. The trial is currently recruiting and accepting new participants.
How is NCT06147037 designed?
This is a interventional study, uses non_randomized allocation, follows a sequential design, employs none masking.
What are the primary outcomes being measured in NCT06147037?
The primary outcome measures are: Evaluate safety and tolerability of [111In]-FPI-2107, FPI-2053, and [225Ac]-FPI-2068 (From informed consent up to approximately 5 years post last administration); Determine radiation dose of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest. (Within 56 days of administration); Determine the RP2D of [225Ac]-FPI-2068, given with or without FPI-2053 (56 days post administration); Determine the effect of predose administration of varying doses of FPI-2053 on the radiation dosimetry of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest. (56 days post-administration). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06147037 being conducted?
This trial is being conducted at 15 sites, including Irvine, California; Palo Alto, California; Santa Monica, California; Chicago, Illinois and 11 more sites (United States, Canada).
Where can I find official information about NCT06147037?
The official record for NCT06147037 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06147037. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06147037 testing in simple terms?
This study is testing a new drug called [225Ac]-FPI-2068, which is a type of targeted radiation therapy, along with an imaging agent and another drug called FPI-2053. It is for adults with advanced solid tumors that have spread or cannot be removed by surgery, and for whom standard treatments are no longer working or are not suitable.
Why is this trial significant?
This trial is important because it explores a novel targeted radiation therapy that aims to deliver cancer-killing radiation directly to tumor cells, potentially offering a new treatment option for pa
What are the potential risks of participating in NCT06147037?
The main risks involve side effects from the study drugs, which can include reactions at the injection site, fatigue, nausea, and potential damage to healthy organs from radiation. Specific risks related to radiopharmaceuticals include potential for radiation exposure to others and the need for precautions. The study will closely monitor for any unexpected or severe side effects. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06147037?
Ask your doctor about the specific type of cancer you have and if it matches the types being studied. Understand that this is a dose-escalation study, meaning the dose of the radiation therapy will be carefully increased to find the safest and most effective level. Participation involves regular clinic visits for drug administration, imaging scans, and monitoring for side effects over several years. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06147037 signal from an investment perspective?
This Phase 1 trial represents an early-stage investment in a novel radiopharmaceutical therapy platform targeting common and difficult-to-treat solid tumors, with potential for significant market impa This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive the study drugs through an IV, and will undergo imaging scans. The study involves dose escalation to find the right dose. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.