Study of AMG 256 in Adult Subjects With Advanced Solid Tumors

Recruiting at 10 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Disqualifiers: Primary brain tumor, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called AMG 256 in adults to see if it is safe and to find the best dose for future studies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

Inclusion Criteria

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

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

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

History of solid organ transplantation

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of AMG 256

8-12 weeks

Dose Expansion

Participants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• AMG 256

Participant Groups

Group I: Dose Expansion Phase: Group 2 Experimental Treatment 1 Intervention

Participants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study.

Group II: Dose Expansion Phase: Group 1 Experimental Treatment 1 Intervention

Participants will be administered with the MTD or RP2D of AMG 256 identified in the dose escalation part of the study.

Group III: Dose Escalation Phase Experimental Treatment 1 Intervention

Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose RP2D of AMG 256.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London