AMG 256 for Cancer

No longer recruiting at 13 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AMG 256 for advanced solid tumors, which are cancers no longer treatable with surgery or radiation. The main goal is to assess the safety of AMG 256 and determine the right dose for future studies. Researchers will try different doses to identify the safest and most effective one. Individuals with solid tumors that have spread, do not respond to standard treatments, or have no other treatment options might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that AMG 256 is likely to be safe for humans?

Research shows that AMG 256 remains in the early stages of human testing, particularly for those with advanced solid tumors. As this is among the first trials in humans, limited information exists about its safety. This type of study aims to determine the maximum safe dosage.

Researchers closely monitor for side effects or problems in these early studies. They seek the safest dose that remains effective. Currently, the primary goal is to assess how well people tolerate AMG 256 and identify any side effects. Detailed data on tolerance is not yet available.

Since this study is in its early stages, the focus is on ensuring safety before expanding to larger groups. Although early trials often involve unknowns, careful monitoring helps maintain participant safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

AMG 256 is unique because it targets advanced solid tumors by potentially offering a new mechanism of action that differs from the current standard treatments such as chemotherapy, radiation, or targeted therapies. Unlike traditional methods that often attack both healthy and cancerous cells, AMG 256 aims to selectively target tumor cells, which could lead to fewer side effects and improved patient outcomes. Researchers are excited about AMG 256 because it represents a novel approach in cancer treatment, with the potential to improve efficacy and safety profiles compared to existing options.

What evidence suggests that AMG 256 could be an effective treatment?

Research is investigating AMG 256 as a potential treatment for advanced solid tumors. Although new, early animal studies have shown promising results. For instance, at medium to high doses, AMG 256 did not significantly harm the immune system, suggesting safety at these levels. However, further research is needed to confirm its effectiveness in humans. This trial includes a Dose Escalation Phase to determine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of AMG 256. Following this, the Dose Expansion Phase will administer the identified MTD or RP2D to further evaluate its safety and effectiveness. Current studies focus primarily on finding the optimal dose for future trials. ^{2 6 7 8 9}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• AMG 256

How Is the Trial Designed?

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

Citations

1. jitc.bmj.com jitc.bmj.com/content/8/Suppl_3/A254.1

417 Design and rationale of a phase 1 study evaluating ... This first-in-human (FIH) study will assess safety, tolerability, and estimated dosing of AMG 256 monotherapy in patients with advanced solid tumors.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10858450/

Translatability of findings from cynomolgus monkey to ... AMG 256 elicited ADA in 28 of 33 subjects (84.8%). However, ADA responses were only robust and exposure-impacting at the 2 lowest doses. At mid to high doses, ...

3. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04362748/

Clinical Trial: NCT04362748 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 (RP2 ...

4. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/bitstreams/61c67b42-6cce-49c4-b116-f94ccca9e8d0/download

417 Design and rationale of a phase 1 study evaluating AMG ... This first-in-human (FIH) study will assess safety, tolerability, and estimated dosing of AMG. 256 monotherapy in patients with advanced solid tumors. Methods ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/15/5/e088578

A phase I, open-label, multicentre, first-in-human study to ... AMG 404 monotherapy was tolerable at the tested doses, with encouraging antitumour activity observed across tumour types.

6. medchemexpress.com medchemexpress.com/latikafusp.html?srsltid=AfmBOorCkrn_XzTZ3vKhl1wsO5w0CbMIRFVALIKnWbUdoO7wH2DsTic2

Latikafusp (AMG 256) | Anti-PD-1 Antibody/IL-21 Mutein Latikafusp is designed to prime and extend the activity of cytotoxic and memory T cells and induce anti-tumor immunity. Latikafusp has the potential for solid ...

7. app.trialscreen.org app.trialscreen.org/trials/phase-1-advanced-solid-tumors-amg-256-adult-subjects-trial-nct04362748

Study of AMG 256 in Adult Subjects With Advanced Solid ... 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 (RP2 ...

8. amgen.com amgen.com/products/safety-data-sheets

Safety Data Sheets To the best of our knowledge, the information provided in each SDS is accurate, and based on data available to Amgen, as of the date of the Safety Data Sheet.

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2021/214665Orig1s000MultidisciplineR.pdf

214665Orig1s000 - accessdata.fda.gov Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG ... data were compared to safety data from patients with KRAS G12C-mutated tumors when.