A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
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| ClinicalTrials.gov Identifier: NCT06147037 |
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Recruitment Status :
Recruiting
First Posted : November 27, 2023
Last Update Posted : May 10, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Solid Tumor Metastatic Colorectal Carcinoma Head and Neck Squamous Cell Carcinoma Non-small Cell Lung Cancer Pancreatic Ductal Adenocarcinoma | Drug: FPI-2053 Drug: [111In]-FPI-2107 Drug: [225Ac]-FPI-2068 | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 110 participants |
| Allocation: | N/A |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours |
| Estimated Study Start Date : | June 28, 2024 |
| Estimated Primary Completion Date : | December 30, 2026 |
| Estimated Study Completion Date : | December 30, 2027 |
| Arm | Intervention/treatment |
|---|---|
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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. |
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. |
- Evaluate safety and tolerability of [111In]-FPI-2107, FPI-2053, and [225Ac]-FPI-2068 [ Time Frame: Approximately 4 years post final administration ]• Incidence of Adverse Events and evaluation of dosimetry
- Radiation dose of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest. [ Time Frame: Within 56 days of administration ]
- For Part A, evaluate the impact of pre-dose administration of FPI-2053 on the radiation dosimetry of [111In]-FPI-2107 (whole body, organs, and selected regions of interest)
- Estimate the effect of pre-dose administration of FPI-2053 on the radiation dosimetry of [225Ac]-FPI-2068 (whole body, organs, and selected regions of interest)
- Maximum tolerated dose of [225Ac]-FPI-2068 and FPI-2053 [ Time Frame: 56 days post administration ]Determine the RP2D of [225Ac]-FPI-2068, given with or without FPI-2053
- Assess preliminary anti-tumor activity of [225Ac]-FPI-2068 [ Time Frame: Approximately 4 years post final administration ]• Tumour assessments will be based on RECIST v1.1 (Eisenhauer et al, 2009) and will be performed approximately every 8 weeks (± 1 week) after the first [225Ac]-FPI-2068 dose, or as clinically indicated.
- Tumor uptake of [111In]-FPI-2107 [ Time Frame: Approximately 56 days of final administration ]• Tumor uptake of [111In]-FPI-2107 in selected regions of interest on SPECT/CT and/or planar images
- Pharmacokinetics (PK) of [111In]-FPI-2107, and [225Ac]-FPI-2068, by measuring changes in clearance, AUC, Cmax, and half-life. [ Time Frame: Approximately 56 days of final administration ]• Determine the plasma concentrations and PK parameters of [111In]-FPI-2107, and [225Ac]-FPI-2068 and the effect of pre-dose administration of FPI-2053 on the plasma concentrations and PK parameters of [111In]-FPI-2107.
- To assess the immunogenicity of [111In]-FPI-2107, [225Ac]-FPI-2068, and FPI-2053 [ Time Frame: Approximately 56 days of final administration ]• Presence of ADA for [111In]-FPI-2107, [225Ac]-FPI-2068, and FPI-2053
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06147037
| Contact: Clinical Trials Fusion Pharmaceuticals Clinical Operations | 1 (888) 506-4215 | clinicaltrials@fusionpharma.com |
| United States, California | |
| Hoag Hospital | Recruiting |
| Irvine, California, United States, 92618 | |
| Contact: Gary Ulaner, MD 949-557-0252 Gary.ulaner@hoag.org | |
| Contact: Beth Thomsen 949-557-0285 Beth.thomsen@hoag.org | |
| Principal Investigator: Gary Ulaner, MD | |
| Stanford Hospital and Clinics | Not yet recruiting |
| Stanford, California, United States, 94305 | |
| Contact: David Marcellus 650-723-4547 dmarcel2@stanford.edu | |
| Principal Investigator: Andrei Iagaru, MD | |
| United States, Illinois | |
| University of Chicago | Not yet recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Aditya Juloori, MD ajuloori@uchicagomedicine.org | |
| Contact: Veronika Seseri vseseri@bsd.uchicago.edu | |
| Principal Investigator: Aditya Juloori, MD | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Not yet recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Heather Jacene, MD 617-632-3767 hjacene@bwh.harvard.edu | |
| Contact: Kristen Harrington 617-582-8218 KristenV_Harrington@dfci.harvard.edu | |
| Principal Investigator: Heather Jacene, MD | |
| United States, Missouri | |
| Washington University in St. Louis | Not yet recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Richard Wahl, MD 314-747-9237 rwahl@wustl.edu | |
| Contact: John Crandall 314-747-5561 jcrandall@wustl.edu | |
| Principal Investigator: Richard Wahl, MD | |
| United States, Pennsylvania | |
| UPMC Hillman Cancer Center Research Pavilion | Withdrawn |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| MD Anderson Cancer Center | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jordi Rodon Ahnert, MD 713-792-5603 JRodon@mdanderson.org | |
| Contact: Yang Lu, MD (713) 792-5768 ylu10@mdanderson.org | |
| Principal Investigator: Jordi Rodon Ahnert, MD | |
| United States, Washington | |
| University of Washington/Fred Hutchinson Cancer Center | Not yet recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Delphine Chen, MD 206-606-6777 dlchen7@uw.edu | |
| Contact: Heather White hwhite@fredhutch.org | |
| Principal Investigator: Delphine Chen, MD | |
| Canada, Quebec | |
| CHUM | Not yet recruiting |
| Montréal, Quebec, Canada, H2X 0C1 | |
| Contact: Daniel Juneau, MD 514-890-8180 daniel.juneau.med@ssss.gouv.qc.ca | |
| Principal Investigator: Daniel Juneau, MD | |
| CIUSSS de l'Estrie - CHUS | Not yet recruiting |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Contact: Michel Pavic, MD 8193461110 ext 74816 Michel.Pavic@USherbrooke.ca | |
| Contact: Christine Lawson 819-346-1110 ext 12942 christine.lawson.ciussse-chus@ssss.gouv.qc.ca | |
| Sub-Investigator: Éric Turcotte, MD | |
| Principal Investigator: Michel Pavic, MD | |
| Study Director: | Lisa Jean-Louis | Fusion Pharmaceuticals Inc. |
| Responsible Party: | Fusion Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT06147037 |
| Other Study ID Numbers: |
FPI-2068-101 |
| First Posted: | November 27, 2023 Key Record Dates |
| Last Update Posted: | May 10, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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FPI-2068 FPI-2107 FPI-2053 FPI-1784 Actinium-225 225Ac Indium-111 111In Solid tumors Targeted alpha therapy TAT Epidermal growth factor receptor EGFR Mesenchymal-epithelial transition factor cMET |
Bispecific antibody Radioimmuno-SPECT agent Radioimmuno-therapeutic agent Monoclonal antibody Bifunctional chelating agent Radiopharmaceutical therapy Alpha particle emitter Directed bispecific monovalent antibody bsAb Bifunctional chelate mCRC HNSCC NSCLC PDAC RLT |
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Carcinoma Squamous Cell Carcinoma of Head and Neck Colorectal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Carcinoma, Squamous Cell Head and Neck Neoplasms |
Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |