Informations générales (source: ClinicalTrials.gov)
Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
Interventional
Phase 1
Amgen (Voir sur ClinicalTrials)
juin 2023
février 2028
09 mai 2025
The primary objective of this study is to:
- Evaluate the safety and tolerability of AMG 305 in adult participants
- Determine the optimal biologically active dose (OBD), at or below the maximum
tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as
the maximum tolerated target dose
- Determine the recommended phase 2 dose (RP2D)
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Antoine HOLLEBECQUE | 18/06/2024 12:25:35 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut Universitaire du Cancer Toulouse Oncopole - 31059 - Toulouse cedex 9 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Participant has provided informed consent to the main study prior to initiation of
any study specific activities/procedures
- Male or female participants age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Participants with histologically or cytologically documented selected solid tumor
diseases. Participants must have exhausted available standard of care (SOC) systemic
therapy or must not be candidates for such available therapy
- For dose expansion cohorts: participants with at least 1 measurable lesion ≥10 mm
which has not undergone biopsy within 3 months of screening scan. This lesion cannot
be biopsied at any time during the study
- Life expectancy > 3 months
- Adequate organ function
Key
- Participant has provided informed consent to the main study prior to initiation of
any study specific activities/procedures
- Male or female participants age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Participants with histologically or cytologically documented selected solid tumor
diseases. Participants must have exhausted available standard of care (SOC) systemic
therapy or must not be candidates for such available therapy
- For dose expansion cohorts: participants with at least 1 measurable lesion ≥10 mm
which has not undergone biopsy within 3 months of screening scan. This lesion cannot
be biopsied at any time during the study
- Life expectancy > 3 months
- Adequate organ function
Key
- Untreated central nervous system (CNS) metastases, leptomeningeal disease, or spinal
cord compression
- History of other malignancy within the past 2 years
- Ongoing or active infection (including chronic or localized)
- Any pleural effusion or pericardial effusion within 4 weeks or ascites requiring
recurrent drainage procedures or other medical intervention within 2 weeks prior to
the first dose of the investigational products.
- Known interstitial lung disease
- Positive test for human immunodeficiency virus (HIV)
- Positive hepatitis B surface antigen or positive hepatitis C virus ribonucleic acid
(RNA) by polymerase chain reaction (PCR)
- History of non-infectious/immune-checkpoint inhibitor related pneumonitis that
required corticosteroids, or current or suspected pneumonitis that cannot be ruled
out by imaging at screening.
- Anticancer therapies including radiotherapy (with the exception of palliative
radiation) chemotherapy or molecularly targeted treatments or tyrosine kinase
inhibitors (TKI) within 4 weeks of administration of the first dose of AMG 305;
checkpoint inhibitor therapy within 3 months of the first dose of AMG 305; or other
immunotherapies/monoclonal antibodies within 3 weeks of administration of the first
dose of AMG 305.
- Has had a major surgery within 4 weeks of administration of a first dose of study
treatment
- Autoimmune disorders requiring chronic systemic steroid therapy or any other form of
immunosuppressive therapy while on study (eg, ulcerative colitis, Crohn's disease)
- Live and/or live-attenuated vaccines received within 28 days (or longer, if required
locally) prior to the first dose of AMG 305
- Participants with unresolved toxicities from prior anti-tumor therapies to Common
Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 or better, with
the exception of alopecia and grade 2 peripheral neuropathy, which has been
unchanged within the last 2 months and there is agreement to allow by both the
investigator and sponsor
- Currently receiving treatment in another investigational device or drug study
- Female participants of childbearing potential or male participants unwilling to use
protocol specified method of contraception
- Females who are pregnant, breastfeeding or who plan to breastfeed or become pregnant
while on study
- History or evidence of any other clinically significant disorder, condition, or
disease (with the exception of those outlined above) that, in the opinion of the
investigator or Amgen physician, if consulted, would pose a risk to participant
safety or interfere with the study evaluation, procedures or completion