RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing humanized monoclonal anti-FGFR1 antibody OM-RCA-01 for Renal Cell Carcinoma Metastatic

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.

Official registry: https://clinicaltrials.gov/study/NCT07292168 · Kidney Cancer Research Bureau · enrollment listed as 64

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are humanized monoclonal anti-FGFR1 antibody OM-RCA-01. The registry lists allocation as na. 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).

They plan to enroll about 64 people at 5 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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.

Interventions: humanized monoclonal anti-FGFR1 antibody OM-RCA-01

Primary outcome (registry wording): Primary endpoint in the phase 1b study

Who it is for (from inclusion criteria)

Ages 18 Years to any
Age ≥ 18 years at the time of consent
Body weight ≥ 50 kg
Histologically confirmed metastatic solid tumors:
clear-cell renal cell carcinoma;
non-small cell lung cancer (adenocarcinoma or squamous cell cancer without EGFR and ALK mutations);
prostate cancer (castration-resistant adenocarcinoma);
breast cancer (adenocarcinoma with specified status for estrogen receptors, progesterone receptors, HER2);

Who the registry excludes

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
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
History of or current evidence of any condition, therapy, or laboratory abnormality that could:
Limit interpretation of study results,

Public study contact (from the registry)

Ilya Tsimafeyeu, MD, PhD

9178914943

sten_to@mail.ru

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

5 listed

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)

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FAQ about this NCT record

Is NCT07292168 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07292168?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07292168?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary