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NCT07094113

AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors

Traducción pendiente · disponible pronto
Reclutando Fase 1

Descripción

The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AMG 410 when administered alone or in combination with other agents in participants with advanced or metastatic solid tumors harboring KRAS alterations.

This is a dose-escalation study in which participants will be assigned to multiple dose levels (DLs) of AMG 410, either as monotherapy or in combination with other agents, followed by expansion cohorts. The goal is to determine the Maximum Tolerated Dose (MTD)-the highest dose with acceptable safety and manageable side effects-or the Recommended Phase 2 Dose (RP2D) of AMG 410 in adult participants with KRAS-altered advanced or metastatic solid tumors.

Criterios de Elegibilidad

Inclusion Criteria:

1. Age ≥ 18 years (or \> legal age within the country if it is older than 18 years).

2. Pathologically documented, locally-advanced or metastatic malignancy with any missense mutation in the KRAS gene or evidence of KRAS amplification using an analytically validated KRASWT amplification assay.

3. Participants must have no standard of care treatment options or have actively refused such therapy.

4. Able to swallow and retain per oral administered study treatment.

5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

6. Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as determined by the site investigator.

7. Adequate organ function.

8. Archival (formalin-fixed, paraffin-embedded \[FFPE\]) tumor tissue or block collected within 5 years before screening must be available. Participants without archived tumor tissue may undergo tumor biopsy before AMG 410 dosing (Day1).

Exclusion Criteria:

1. Untreated symptomatic central nervous system or leptomeningeal metastases.

2. Uncontrolled pleural effusion and/or ascites.

3. History of other malignancy within the past 5 years.

4. Active systemic infection or symptoms that indicate an acute and/or uncontrolled infection requiring IV antibiotics within 7days prior to the first dose of study treatment.

5. History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis).

6. Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of study treatment.

7. History of solid organ transplant.

8. Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of study treatment.

9. Presence or history of any of the following viral infections: HIV, Hepatitis C, Hepatitis B, and active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

10. Toxicities from prior anti-tumor therapy (including radiotherapy) not having improved to at least Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1.

11. Therapeutic or palliative radiation therapy within 2 weeks of first dose of study treatment.

12. Major surgery within 28 days of first dose of study treatment.

13. History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.

Información del Ensayo

NCT07094113
Reclutando
Fase 1
434 participantes
Jul 2025
Abr 2028

Ubicaciones35

Australia (3)
Chris OBrien Lifehouse
Camperdown, New South Wales, 2050 Reclutando
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011 Reclutando
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000 Reclutando
Belgium (1)
Universitair Ziekenhuis Gent
Ghent, 9000 Reclutando
Canada (2)
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5 Reclutando
Sir Mortimer B Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2 Reclutando
China (2)
Beijing Cancer Hospital
Beijing, 100142 Reclutando
Jinan Central Hospital
Jinan, Shandong, 250013 Reclutando
Denmark (1)
Rigshospitalet
Copenhagen, 2100 Reclutando
France (2)
Centre Leon Berard
Lyon, 69008 Reclutando
Gustave Roussy
Villejuif, 94805 Reclutando
Germany (1)
Universitaetsklinikum Essen
Essen, 45147 Reclutando
Italy (3)
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162 Reclutando
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126 Reclutando
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona, 37134 Reclutando
Japan (3)
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681 Reclutando
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577 Reclutando
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045 Reclutando
Netherlands (1)
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX Reclutando
South Korea (2)
Asan Medical Center
Seoul, 05505 Reclutando
Seoul National University Hospital
Seoul, 03080 Reclutando
Spain (2)
Fundacion Jimenez Diaz
Madrid, 28040 Reclutando
Hospital Universitario 12 de Octubre
Madrid, 28041 Reclutando
United Kingdom (2)
Sarah Cannon Research Institute UK
London, W1G 6AD Reclutando
Royal Marsden Hospital
Sutton, SM2 5PT Reclutando
United States (10)
City of Hope National Medical Center
Duarte, California, 91010 Reclutando
University of California Los Angeles
Los Angeles, California, 90095 Reclutando
Emory University
Atlanta, Georgia, 30322 Reclutando
Massachusetts General Hospital
Boston, Massachusetts, 02114 Reclutando
Siteman Cancer Center - Washington University
St Louis, Missouri, 63110 Reclutando
Duke Cancer Center
Durham, North Carolina, 27710 Reclutando
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107 Reclutando
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, 37203 Reclutando
Next Oncology
San Antonio, Texas, 78229 Reclutando
Next Virginia
Fairfax, Virginia, 22031 Reclutando