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JOURNAL ONKOLOGIE – STUDIE

Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors

Rekrutierend

NCT-Nummer:
NCT05800964

Studienbeginn:
Juni 2023

Letztes Update:
11.04.2024

Wirkstoff:
AMG 305

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Studienlocations
(3 von 19)

Universitaetsklinikum Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Wuerzburg
97078 Wuerzburg
(Bayern)
GermanyRekrutierend» Google-Maps
City of Hope National Medical Center
91010 Duarte
United StatesRekrutierend» Google-Maps
Hackensack University Medical Center
07601 Hackensack
United StatesRekrutierend» Google-Maps
New York University Cancer Institute
10016 New York
United StatesRekrutierend» Google-Maps
Thomas Jefferson University
19107 Philadelphia
United StatesRekrutierend» Google-Maps
Sarah Cannon Research Institute
37203 Nashville
United StatesRekrutierend» Google-Maps
Peter MacCallum Cancer Centre
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Institut Universitaire du Cancer Toulouse Oncopole
31059 Toulouse cedex 9
FranceRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa-shi
JapanRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Hospital Clinic i Provincial de Barcelona
08036 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Madrid Sanchinarro
28050 Madrid
SpainRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

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)

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

Pre-screening:

- Participant has provided informed consent prior to initiation of any pre screening

study specific activities/procedures.

- Participants with histologically or cytologically documented solid tumor diseases

expressing cadherin-3 and mesothelin (by mRNA in the Cancer Genome Atlas Program

[TCGA] database), including CRC, NSCLC, mesothelioma, pancreatic cancer, gastric

cancer, head and neck cancer, cervical carcinoma, uterine carcinoma, and breast cancer

Clinical study:

- Participant has provided inform 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 solid tumor diseases,

including CRC, NSCLC, mesothelioma, pancreatic cancer, GC, head and neck cancer,

cervical carcinoma, uterine carcinoma, and breast cancer. 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 Exclusion Criteria:

- 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

- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent

drainage procedures

- 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)

- Anticancer therapies including radiotherapy (with the exception of palliative

radiation) chemotherapy or molecularly targeted treatments or tyrosine kinase

inhibitors (TKI) within 4 weeks or 5 half lives (whichever is longer) of

administration of a first dose of study treatment; immunotherapies/monoclonal

antibodies within 3 weeks of administration of a first dose of study treatment.

- 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

- 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

Studien-Rationale

Primary outcome:

1. Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) (Time Frame - Day 1 to Day 28)

2. Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs) (Time Frame - Up to a maximum of 2 years):
Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests, as assessed by the investigator, will also be reported as TEAEs.

3. Percentage of Participants who Experience Treatment-Related Adverse Events (Time Frame - Up to a maximum of 2 years)

Secondary outcome:

1. Maximum Serum Concentration (Cmax) of AMG 305 (Time Frame - Up to a maximum of 2 years)

2. Minimum Serum Concentration (Cmin) of AMG 305 (Time Frame - Up to a maximum of 2 years)

3. Area Under the Concentration-Time Curve (AUC) of AMG 305 (Time Frame - Up to a maximum of 2 years)

4. Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (Time Frame - Up to a maximum of 2 years):
ORR is defined as best overall response (BOR) of complete response (CR) or partial response (PR), Clinical Benefit Rate (defined as BOR of CR, PR, or stable disease [SD] with duration of 24 weeks or longer) based on RECIST v1.1.

5. ORR based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST) (Time Frame - Up to a maximum of 2 years):
ORR is defined as immune best overall response (iBOR) of immune complete response (iCR) or immune partial response (iPR), Clinical Benefit Rate (defined as iBOR of iCR, iPR, or immune stable disease [iSD] with duration of 24 weeks or longer) based on iRECIST.

6. Duration of Response (DOR) (Time Frame - Up to a maximum of 2 years):
DOR is defined as the time from the first documentation of objective response until the first documentation of disease progression or death due to any cause, whichever occurs first) by RECIST v1.1 and iRECIST.

7. Time to Progression (Time Frame - Up to a maximum of 2 years):
Time to progression is defined as the time rom first AMG 305 dose until the first documentation of radiological disease progression by RECIST v1.1 and iRECIST.

8. Progression-Free Survival (PFS) (Time Frame - Up to a maximum of 2 years):
PFS is defined as the time from first AMG 305 dose until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first) by RECIST v1.1 and iRECIST.

9. Overall Survival (OS) at 1 Year (Time Frame - 1 year)

10. OS at 2 Years (Time Frame - 2 years)

Studien-Arme

  • Experimental: Part A: Dose Exploration
    Participants will receive escalating doses of AMG 305.
  • Experimental: Part B: Dose Expansion
    Participants with non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic cancer, and other solid tumors will receive the RP2D identified in Part A.

Geprüfte Regime

  • AMG 305:
    Short-term intravenous (IV) infusion

Quelle: ClinicalTrials.gov


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