ACTIVE_NOT_RECRUITING

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

Conditions

Advanced Solid Tumors Safety Tolerability Pharmacokinetics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2023-06-13

Study Completion:2026-04-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05800964

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

STUDY_DIRECTOR

Amgen

Study Locations (Sites)

City of Hope National Medical Center

Duarte, California, 91010

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

New York University Cancer Institute

New York, New York, 10016

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

United States

Next Oncology

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Amgen

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-13

Study Completion Date2026-04-10

Study Record Updates

Study Start Date2023-06-13

Study Completion Date2026-04-10

Terms related to this study

Keywords Provided by Researchers

Safety
Tolerability
Pharmacokinetics

Additional Relevant MeSH Terms

Advanced Solid Tumors