Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-25 @ 3:08 PM
Study NCT ID:
NCT07292168
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Expressing Fibroblast Growth Factor Receptor 1
Sponsor:
Kidney Cancer Research Bureau
Organization:
Study Overview
Official Title:
A Phase 1b/2 Study Evaluating the Safety and Preliminary Efficacy of OM-RCA-01, an Anti-FGFR1 Monoclonal Antibody, in Patients With Metastatic Cancers Expressing FGFR1.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAGNOT
Brief Summary:
One of the most relevant targets in the field of novel targeted anticancer therapy is the family of receptors to fibroblast growth factor receptors (FGFRs). FGFR1 is the main representative of the FGFR family.
The goal of this clinical trial is to learn if monoclonal anti-FGFR1 antibody (OM-RCA-01) works to treat metastatic cancers expressing FGFR1. It will also learn about the safety of drug OM-RCA-01. The main questions it aims to answer are:
1. What medical problems do participants have when receiving drug OM-RCA-01?
2. What dose of the drug should patients receive in the next studies?
3. Does tumor growth slow down in patients receiving OM-RCA-01?
All patients in this study will receive the antibody treatment. The drug will be given through a vein (by IV infusion) every two weeks, for as long as the disease remains under control and the treatment is well tolerated.
The goal of this clinical trial is to learn if monoclonal anti-FGFR1 antibody (OM-RCA-01) works to treat metastatic cancers expressing FGFR1. It will also learn about the safety of drug OM-RCA-01. The main questions it aims to answer are:
1. What medical problems do participants have when receiving drug OM-RCA-01?
2. What dose of the drug should patients receive in the next studies?
3. Does tumor growth slow down in patients receiving OM-RCA-01?
All patients in this study will receive the antibody treatment. The drug will be given through a vein (by IV infusion) every two weeks, for as long as the disease remains under control and the treatment is well tolerated.
Detailed Description:
FGFR1 is expressed on cells of various tumors, enabling their development. Currently, there are no reported monoclonal antibodies that block FGFR1, and only one chemically synthesized non-selective pan-FGFR inhibitor has been approved in the treatment of FGFR1-positive relapsed or refractory myeloid/lymphoid neoplasms.
OM-RCA-01 is an original innovative targeting drug focused on blocking FGFR1. OM-RCA-01 binds to the extracellular part of FGFR1. The main mechanism of action is blocking the activation processes of FGFR1. In studies, OM-RCA-01 was found to be a high-affinity and specific to FGFR1 antibody, inhibiting the phosphorylation of the receptor and the subsequent intracellular cascade. The amount of human protein in the structure of the humanized antibody is 92.9%.
The present clinical trial is a Phase 1b/2, multicenter, open-label, non-randomized, cohort study designed to evaluate the safety and preliminary efficacy of the monoclonal antibody OM-RCA-01 in patients with metastatic solid tumors expressing FGFR1.
This study adopts a basket trial design, enrolling patients based on the shared molecular characteristic of FGFR1 expression regardless of tumor histology. This approach enables the assessment of the anti-FGFR1 antibody's activity across multiple tumor types simultaneously.
Patients with FGFR1 expression meeting inclusion criteria (see the relevant section) will be enrolled into one of five tumor-specific cohorts:
* Renal cell carcinoma (RCC);
* Non-small cell lung cancer (NSCLC);
* Head and neck cancer (HNC);
* Breast cancer (BC);
* Prostate cancer (PCa) A total of 58 patients will be included. The study drug is administered intravenously, every 14 days till disease progression (RECIST 1.1) or unexaptable toxicity (CTCAE v.5.0).
OM-RCA-01 is an original innovative targeting drug focused on blocking FGFR1. OM-RCA-01 binds to the extracellular part of FGFR1. The main mechanism of action is blocking the activation processes of FGFR1. In studies, OM-RCA-01 was found to be a high-affinity and specific to FGFR1 antibody, inhibiting the phosphorylation of the receptor and the subsequent intracellular cascade. The amount of human protein in the structure of the humanized antibody is 92.9%.
The present clinical trial is a Phase 1b/2, multicenter, open-label, non-randomized, cohort study designed to evaluate the safety and preliminary efficacy of the monoclonal antibody OM-RCA-01 in patients with metastatic solid tumors expressing FGFR1.
This study adopts a basket trial design, enrolling patients based on the shared molecular characteristic of FGFR1 expression regardless of tumor histology. This approach enables the assessment of the anti-FGFR1 antibody's activity across multiple tumor types simultaneously.
Patients with FGFR1 expression meeting inclusion criteria (see the relevant section) will be enrolled into one of five tumor-specific cohorts:
* Renal cell carcinoma (RCC);
* Non-small cell lung cancer (NSCLC);
* Head and neck cancer (HNC);
* Breast cancer (BC);
* Prostate cancer (PCa) A total of 58 patients will be included. The study drug is administered intravenously, every 14 days till disease progression (RECIST 1.1) or unexaptable toxicity (CTCAE v.5.0).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: