Study of AMG 256 in Adult Subjects With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 256 in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04362748
• Other study ID #: 20180144
• Status: Completed
• Phase: Phase 1
• Start date: September 15, 2020
• Est. completion date: September 21, 2023

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of AMG 256 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 21, 2023
• Est. primary completion date: September 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Participant has provided informed consent prior to initiation of any study specific activities/procedures.

• Age = 18 years at the time of signing informed consent.

• Life expectancy of > 3 months, in the opinion of the investigator.

• Participant must have histologically or cytologically proven metastatic or locally advanced solid tumors not amenable to curative treatment with surgery or radiation for which:

• No standard therapy exists, or

• Standard therapy has failed, not available, or

• In the investigator's opinion, standard therapy does not result in meaningful clinical benefit.

• 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.

Exclusion Criteria:

• Primary brain tumor, untreated or symptomatic brain metastases and leptomeningeal disease.

• History of other malignancy within the past 2 years, with the following Exceptions:

• Malignancy treated with curative intent and with no known active disease present for = 2 years before enrollment and felt to be at low risk for recurrence by the treating physician.

• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.

• Adequately treated cervical carcinoma in situ without evidence of disease.

• Adequately treated breast ductal carcinoma in situ without evidence of disease.

• Prostatic intraepithelial neoplasia without evidence of prostate cancer.

• Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.

• History of solid organ transplantation.

• Major surgery within 28 days of study day 1.

• Live vaccine therapy within 4 weeks prior to study day 1.

• Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.

• Active infection requiring oral or intravenous therapy.

• Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or cardiac arrhythmia requiring medication.

• History of severe allergic reactions or severe acute hypersensitivity reaction.

• Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 3 months after the last dose of AMG 256.

• Female participants of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 3 months after the last dose of AMG 256.

• Female participants of childbearing potential with a positive pregnancy test assessed within 48 hours prior to day 1 of treatment by a serum pregnancy test.

• Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 5 months after the last dose of AMG 256.

• Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 5 months after the last dose of AMG 256.

• Male participants unwilling to abstain from donating sperm during treatment and for an additional 5 months after the last dose of AMG 256.

• Participant has known sensitivity to any of the products or components to be administered during dosing.

• Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.

• History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participants safety or interfere with the study evaluation, procedures or completion.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• AMG 256
AMG 256 administered as an intravenous (IV) infusion.

Locations

Country	Name	City	State
Australia	Chris OBrien Lifehouse	Camperdown	New South Wales
Australia	Monash Medical Centre	Clayton	Victoria
Australia	St Vincents Hospital Sydney	Darlinghurst	New South Wales
Belgium	Cliniques Universitaires Saint Luc	Bruxelles
Belgium	Universitair Ziekenhuis Gent	Gent
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona	Cataluña
Spain	Hospital Universitari Vall d Hebron	Barcelona	Cataluña
United States	City of Hope National Medical Center	Duarte	California
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Spain, 

References & Publications (1)

Kroenke MA, Starcevic Manning M, Zuch de Zafra CL, Zhang X, Cook KD, Archer M, Lolkema MP, Wang J, Hoofring S, Saini G, Aeffner F, Ahern E, Cabanas EG, Govindan R, Hui M, Gupta S, Mytych DT. Translatability of findings from cynomolgus monkey to human suggests a mechanistic role for IL-21 in promoting immunogenicity to an anti-PD-1/IL-21 mutein fusion protein. Front Immunol. 2024 Jan 26;15:1345473. doi: 10.3389/fimmu.2024.1345473. eCollection 2024. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Dose Limiting Toxicities (DLTs)		28 days
Primary	Number of Participants with Treatment-emergent Adverse Events (TEAEs)		Up to 2.5 Years
Primary	Number of Participants with Treatment-Related Adverse Events		Up to 2.5 Years
Primary	Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement		Up to 2 Years
Primary	Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests		Up to 2 Years
Primary	Maximum Tolerated Dose (MTD) of AMG 256		28 days
Primary	Recommended Phase 2 Dose (RP2D) of AMG 256		28 days
Secondary	Maximum Observed Plasma Concentration (Cmax) of AMG 256		Up to 2.5 Years
Secondary	Time to Achieve Cmax (Tmax) of AMG 256		Up to 2.5 Years
Secondary	Area Under the Plasma Concentration-time Curve (AUC) of AMG 256		Up to 2.5 Years
Secondary	Objective Response (OR)		Up to 2.5 Years
Secondary	Duration of Response (DOR)		Up to 2.5 Years
Secondary	Progression-Free Survival (PFS)		Up to 1 Year
Secondary	Disease Control Rate (DCR)		Up to 2.5 Years
Secondary	Duration of Stable Disease		Up to 2.5 Years
Secondary	Overall Survival (OS)		Up to 2 Years
Secondary	Number of Participants with anti-AMG 256 Antibodies		Up to 2.5 Years

External Links

•   AmgenTrials clinical trials website