OM-RCA-01 (anti-FGFR1 antibody) for metastatic tumors that express FGFR1

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.

This trial will try OM-RCA-01, an IV antibody given every two weeks, in adults with metastatic cancers whose tumors test positive for FGFR1 and who have progressed after standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kidney Cancer Research Bureau (Academic / other)
• Drugs / interventions: Chemotherapy, immunotherapy, Radiation
• Locations: 5 sites (Kazan' and 4 other locations)
• Trial ID: NCT07292168 on ClinicalTrials.gov

What this trial studies

This open-label, non-randomized Phase 1b/2 basket trial enrolls patients with different metastatic solid tumors that share FGFR1 expression and treats all participants with the monoclonal antibody OM-RCA-01. The Phase 1b portion focuses on safety and finding an appropriate dose, and the Phase 2 portion looks for early signs that tumor growth slows, using RECIST 1.1 measurable disease criteria. Patients are assigned to tumor-specific cohorts (renal cell, NSCLC, prostate, breast, and head and neck) but enrollment is based on FGFR1 immunohistochemistry (≥2+). Dosing is by intravenous infusion every two weeks while the disease is controlled and treatment is tolerated.

Who should consider this trial

Good fit: Adults (≥18 years, ≥50 kg) with metastatic clear-cell renal cell carcinoma, non-small cell lung cancer (without EGFR/ALK mutations), castration-resistant prostate cancer, certain breast cancers, or head and neck tumors that show FGFR1 expression (IHC ≥2+) and who have progressed after at least two lines of standard therapy are ideal candidates.

Not a fit: Patients whose tumors do not express FGFR1, who have effective standard treatment options available, or who do not meet performance or safety criteria are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, OM-RCA-01 could offer a new targeted treatment option that slows tumor growth in patients with FGFR1-positive metastatic cancers who have limited alternatives.

How similar studies have performed: This approach is novel for a monoclonal antibody specifically targeting FGFR1, with limited prior clinical data for FGFR1-directed antibodies though non-selective pan-FGFR inhibitors have shown activity in other disease settings.

Eligibility criteria

Inclusion Criteria:

1. Signed and dated Informed Consent Form confirming voluntary participation in the study.
2. Age ≥ 18 years at the time of consent.
3. Body weight ≥ 50 kg.
4. Histologically confirmed metastatic solid tumors:

   1. clear-cell renal cell carcinoma;
   2. non-small cell lung cancer (adenocarcinoma or squamous cell cancer without EGFR and ALK mutations);
   3. prostate cancer (castration-resistant adenocarcinoma);
   4. breast cancer (adenocarcinoma with specified status for estrogen receptors, progesterone receptors, HER2);
   5. head and neck tumors (squamous carcinoma, salivary gland cancer).
5. Immunohistochemical expression of FGFR1 of 2+ or higher.
6. Documented disease progression after at least two lines of standard therapy, or lack of available or feasible alternative standard treatment options for any reason.
7. Presence of at least one measurable lesion according to RECIST 1.1 criteria.
8. Availability of formalin-fixed and paraffin-embedded tumor tissue samples for biomarker analysis.
9. ECOG performance status 0 or 1.
10. Adequate organ function, confirmed by laboratory test results obtained within 7 days prior to Cycle 1 Day 1, meeting the following parameters:

    * Hemoglobin level ≥ 90 g/L
    * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
    * Platelet count ≥ 100 × 10⁹/L
    * Serum creatinine level ≤ 1.5 × upper limit of normal (ULN)
    * Glomerular Filtration Rate (GFR) ≥ 30 mL/min
    * AST and ALT ≤ 3 × ULN (≤ 5 × ULN in patients with liver metastases)
    * Serum phosphorus within normal limits (≥ lower limit of normal and ≤ upper limit of normal)
    * Serum calcium ≥ lower limit of normal
    * Serum potassium ≥ lower limit of normal (note: use of medications to increase potassium during screening is permitted)
11. Life expectancy of more than 12 weeks.
12. Absence of any psychological, familial, social or geographical circumstances that could potentially serve as an obstacle to the fulfillment of the study protocol and follow-up procedures according to the prescribed schedule and the ability of the study participant to follow the requirements of the protocol; these circumstances should be discussed with the patient before inclusion in the study.
13. Women capable of childbearing must be using an effective method of contraception.

Exclusion Criteria:

1. Participation in another clinical trial or concomitant treatment with any investigational drug, or administration of any investigational anticancer therapy within 28 days prior to inclusion in this study.
2. Presence of central nervous system (CNS) metastases and/or medullary carcinomatosis at the time of inclusion.

   Exception: Patients with CNS metastases who have received therapy may participate if they have been clinically stable for at least 1 month prior to enrollment, defined by:
   * No evidence of new or progressive CNS metastases
   * No ongoing steroid therapy
   * Stable mental status sufficient to provide informed consent
3. History of or current evidence of any condition, therapy, or laboratory abnormality that could:

   * Limit interpretation of study results,
   * Prevent completion of the study protocol, or
   * Pose a risk to patient safety or well-being. This includes any serious or unstable general medical, psychiatric, or other conditions potentially jeopardizing safety, informed consent, or compliance.
4. Any second malignancy within the previous 5 years, except for adequately treated cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma of the skin with limited growth, provided these are well controlled.
5. Known regular use of illicit substances or recreational drugs, or a history of drug abuse or alcoholism within the past year.
6. Plans to conceive during the study period, current pregnancy, or lactation.
7. Known HIV-positive status.
8. Known active hepatitis B or C infection.
9. Evidence of active bleeding or hemorrhagic diathesis.
10. Radiation therapy within 14 days prior to inclusion.
11. Receipt of any anti-tumor treatments including:

    * Surgery or tumor embolization within 14 days prior to the first OM-RCA-01 dose, or
    * Chemotherapy, immunotherapy, biological therapy, investigational therapy, or endocrine therapy (except ongoing androgen deprivation therapy for prostate cancer) within 14 days or within two half-lives of the drug (whichever is longer) prior to the first OM-RCA-01 dose.
12. Prior treatment with any FGFR-inhibiting or FGFR-blocking agents.

Where this trial is running

Kazan' and 4 other locations

• Republican Dispensary of Tatarstan — Kazan', Russia (Active_not_recruiting)
• A.I. Kryzhanovsky Krasnoyarsk Regional Cancer Center — Krasnoyarsk, Russia (Recruiting)
• Hadassah Medical — Moscow, Russia (Recruiting)
• I.P. Pavlov First Saint Petersburg State Medical University — Saint Petersburg, Russia (Recruiting)
• Republican Clinical Oncology Dispensary — Ufa, Russia (Recruiting)

Study contacts

• Study coordinator: Ilya Tsimafeyeu, MD, PhD

Conditions Renal Cell Carcinoma Metastatic; Prostate Cancer Metastatic; Non-small Cell Lung Cancer Metastatic; Breast Cancer Metastatic; Head & Neck Cancer; metastatic cancer; resistance; monoclonal antibody