Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors

Recruiting at 16 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Must not be taking: Checkpoint inhibitors, Immunosuppressive corticosteroids

Disqualifiers: Primary brain tumor, Recent malignancy, Organ transplant, Active infection, Autoimmune disease, others

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

Compensation: Varies

Number of Visits: 1988

11 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests two experimental drugs, AMG 994 and AMG 404, in patients with advanced cancer. The goal is to find the safest dose and see how well patients can handle these treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had anti-tumor therapy within 21 days, a checkpoint inhibitor within 9 weeks, or live vaccine therapy within 4 weeks before starting the study. It's best to discuss your specific medications with the study team.

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

Inclusion Criteria

Hepatic function, as follows: Total bilirubin (TBL) ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN for participants with liver metastasis Aspartate transaminase (AST) ≤ 3 x ULN or ≤ 5 x ULN for participants with liver metastasis Alanine aminotransferase (ALT) ≤ 3 x ULN or ≤ 5 x ULN for participants with liver metastasis Alkaline phosphatase ≤ 2.5 x ULN or ≤ 5 x ULN for participants with liver metastasis

- Standard systemic therapy has failed or is not available.

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

Exclusion Criteria

Prior/Concomitant Therapy

Other Exclusions

-- Participants with NSCLC squamous cell carcinoma (Part 1), MSLN negative NSCLC squamous cell carcinoma (Part 2), or MSLN negative NSCLC adenocarcinoma (Part 2) once the participant has been screened for MSLN expression.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Exploration

Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of AMG 994, in combination with AMG 404

Up to Day 28 of Cycle 1 (one cycle = 28 days)

Weekly visits for AMG 994, every 4 weeks for AMG 404

Dose Expansion

Participants will be administered with the MTD or RP2D of AMG 994 identified in the dose escalation part of the study, in combination with AMG 404

Up to approximately 19.32 months

Weekly visits for AMG 994, every 4 weeks for AMG 404

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 140 days after last dose

Treatment Details

Interventions

• AMG 404
• AMG 994

Participant Groups

Group I: Part 2: Dose Expansion Experimental Treatment 2 Interventions

Participants will be administered with the MTD or RP2D of AMG 994 identified in the dose escalation part of the study, in combination with AMG 404.

Group II: Part 1c: Dose Exploration Experimental Treatment 2 Interventions

Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of AMG 994, in combination with AMG 404.

Group III: Part 1b: Dose Exploration Experimental Treatment 2 Interventions

Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of AMG 994, in combination with AMG 404.

Group IV: Part 1a: Dose Exploration Experimental Treatment 2 Interventions

Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of AMG 994, in combination with AMG 404.

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