UNKNOWNPhase I/IIEN originalBreast cancerMetastatic / advanced

A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

This trial is no longer recruiting — here are similar active trials

Matched by cancer type/biomarker, currently recruiting.

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The goal of this randomized, double-blind, multi-regional phase 3 study of cadonilimab combined with chemotherapy versus chemotherapy in combination with or without nivolumab for the first-line treatment of participants with HER2-negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma trial is to compare OS between cadonilimab combined with chemotherapy and chemotherapy in combination with or without nivolumab in the ITT population.

RecruitingUnknown phase🇵🇱 PolandColorectal cancerMetastatic / advanced

Metastatic colorectal cancer or mCRC is a cancer that starts in the parts of the large intestine (the colon or rectum) and has already spread to other parts of the body. This cancer can be hard to treat because it can behave differently from one person to another. Over time, treatments may stop working, and side effects can build up. In later treatment stages, there are only a few standard medicine options available. Because of this, studies often look at both how long people live and how treatment affects quality of life. The main aim of this study is to see how long adults in Poland with mCRC live without their cancer getting worse (progression-free survival or PFS) when they receive fruquintinib after at least two previous treatments. Fruquintinib (TAK 113) is a medicine taken by mouth that is designed to slow tumor growth. Other aim is to find out how long adults in Poland with mCRC live while being treated with fruquintinib (overall survival or OS). The study also wants to record how fruquintinib is used in routine care in adults with mCRC in Poland (for example when treatment starts, changes in doses, and how long treatment continues). Another aim is to learn about people with mCRC, such as their medical history and past treatment as well as their quality of life while they are in the study. The study will look at data already existing in the participants' medical charts.

The goal of this clinical trial is to determine the most effective dose of EIK1005 that a person can take safely. Additionally, this study will test how well EIK1005 is tolerated alone and in combination with pembrolizumab in treating patients with advanced cancer.

RecruitingPhase II🇵🇱 PolandLung cancerMetastatic / advanced

The purpose of this study is to evaluate the safety and efficacy of Navlimetostat (BMS-986504) monotherapy or in combination with Izalontamab Brengitecan in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion or MTAP loss after progression on prior therapies.

About the trial

This is an open-label Phase 1/2a study. Once the safety of the BC1 cell line alone has been demonstrated in Phase 1, in Phase 2, patients will be treated with the Bria-OTS regimen (see below) and a clinically available check point inhibitor (CPI). During the monotherapy phase of Phase 1, one patient will be treated intradermally every 2 weeks for 6 weeks (4 doses) with an initial dose of the BC1 cell line. If this dose is tolerated, the next patient will receive an increased dose of BC1. If once again tolerated, the third patient will receive a further dose increase of the BC1. Once at least 3 patients have been safely treated with the BC1 cell line, with no dose-limiting toxicity (DLT), the combinational phase of the study will commence. Following the monotherapy phase, patients will be treated with BC1 and the Bria-OTS regimen (see below) every 3 weeks, plus a CPI at the FDA approved labelled dose and schedule. There will be at least a 2-week spacing between enrollment of each of the first three subjects in the study in order to assess for any early unanticipated risk(s). During the Phase 1 combination and Phase 2 expansion phases, all patients will be treated with BC1 cells as part of the Bria-OTS regimen, which includes cyclophosphamide 300 mg/m2 2-3 days prior to BC1 cell inoculation, and peginterferon alpha-2a administered on the same day, following BC1 cell inoculation.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Potwierdzony histologicznie nawracający rak piersi z przerzutami, na który poprzednie leczenie nie zadziałało (wymogi zależą od typu nowotworu: HER2-dodatni wymaga 2+ leków, hormonochulny wymaga 2+ terapii hormonalnych, potrójnie ujemny wymaga chemioterapii i leków na bazie platyny, przerzuty mózgu muszą być stabilne przez 4 tygodnie i pacjent nie może przyjmować sterydów)
  • •Wiek 18 lat lub więcej
  • •Oczekiwany czas przeżycia co najmniej 4 miesiące
  • •Zadowalający ogólny stan zdrowia (ECOG 2 lub lepiej)
  • •Wszystkie skutki uboczne z poprzedniego leczenia muszą być ustabilizowane i nie przekraczać stopnia 1 (z wyjątkiem łysienia, kontrolowanego zaburzenia hormonalnego i niedokrwistości bez transfuzji)
  • •Poprzednie działania niepożądane związane z immunoterapią nie mogą przekraczać stopnia 2

✗ Disqualifies

  • •Jednoczesne leczenie przeciwnowotworowe
  • •Chemioterapia, radioterapia lub inne leczenie przeciwnowotworowe w ciągu 3 tygodni przed badaniem
  • •Niezagojozone powikłania po zabiegu chirurgicznym
  • •Historia nadwrażliwości na leczenie lub składniki produktu
  • •Poważne zaburzenie funkcji nerek (niski klirens kreatyniny lub wysoki BUN i kreatynina)
  • •Zbyt niskie liczby komórek krwi (granulocyty poniżej 1000 lub płytki poniżej 50 000)
  • •Zaburzenia funkcji wątroby (wysoki bilirubina, fosfataza zasadowa lub enzymy wątrobowe)
  • •Poważne choroby serca (stadium 3-4 według klasyfikacji NYHA)

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 26, 2024
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

Sarcoma Oncology Center

Santa Monica, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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