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

Advanced Solid Tumors Clinical Trial

Official title:

Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05800964
• Other study ID #: 20220073
• Secondary ID: 2022-502867-39
• Status: Recruiting
• Phase: Phase 1
• Start date: June 13, 2023
• Est. completion date: January 14, 2027

Study information

• Verified date: June 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: January 14, 2027
• Est. primary completion date: May 13, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Australia	Chris OBrien Lifehouse	Camperdown	New South Wales
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
France	Institut Universitaire du Cancer Toulouse Oncopole	Toulouse cedex 9
France	Gustave Roussy	Villejuif
Germany	Universitaetsklinikum Dresden	Dresden
Germany	Universitaetsklinikum Essen	Essen
Germany	Universitaetsklinikum Wuerzburg	Wuerzburg
Japan	National Cancer Center Hospital East	Kashiwa-shi	Chiba
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona	Cataluña
Spain	Hospital Universitari Vall d Hebron	Barcelona	Cataluña
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Madrid Sanchinarro	Madrid
United States	City of Hope National Medical Center	Duarte	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	New York University Cancer Institute	New York	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Next Oncology	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Japan,  Korea, Republic of,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who Experience Dose Limiting Toxicities (DLTs)		Day 1 to Day 28
Primary	Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs)	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.	Up to a maximum of 2 years
Primary	Percentage of Participants who Experience Treatment-Related Adverse Events		Up to a maximum of 2 years
Secondary	Maximum Serum Concentration (Cmax) of AMG 305		Up to a maximum of 2 years
Secondary	Minimum Serum Concentration (Cmin) of AMG 305		Up to a maximum of 2 years
Secondary	Area Under the Concentration-Time Curve (AUC) of AMG 305		Up to a maximum of 2 years
Secondary	Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)	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.	Up to a maximum of 2 years
Secondary	ORR based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)	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.	Up to a maximum of 2 years
Secondary	Duration of Response (DOR)	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.	Up to a maximum of 2 years
Secondary	Time to Progression	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.	Up to a maximum of 2 years
Secondary	Progression-Free Survival (PFS)	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.	Up to a maximum of 2 years
Secondary	Overall Survival (OS) at 1 Year		1 year
Secondary	OS at 2 Years		2 years

External Links

•   AmgenTrials clinical trials website