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A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06131398
Recruitment Status : Recruiting
First Posted : November 14, 2023
Last Update Posted : May 30, 2024
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:

The primary objectives of this study are to:

  • Evaluate the safety and tolerability of AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors
  • Determine the recommended phase 2 dose and the maximum tolerated dose for AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: AMG 355 Drug: Pembrolizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 515 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 355 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Actual Study Start Date : March 7, 2024
Estimated Primary Completion Date : February 8, 2027
Estimated Study Completion Date : February 8, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A: AMG 355 monotherapy
Specified dose on specified days
Drug: AMG 355
Short-term intravenous (IV) infusion

Experimental: Group B: AMG 355 and pembrolizumab
Specified dose on specified days
Drug: AMG 355
Short-term intravenous (IV) infusion

Drug: Pembrolizumab
Short-term IV infusion
Other Name: Keytruda




Primary Outcome Measures :
  1. Number of Participants Who Experience a Dose Limiting Toxicity (DLT) [ Time Frame: Day 1 to Day 21 ]
  2. Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) [ Time Frame: Up to 2 years ]
    Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests, as assessed by the investigator, will also be reported as TEAEs.

  3. Number of Participants Who Experience a Treatment-related AE [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Maximum Observed Serum Concentration (Cmax) of AMG 355 [ Time Frame: Up to 85 days ]
  2. Minimum Observed Serum Concentration (Cmin) of AMG 355 [ Time Frame: Up to 85 days ]
  3. Area Under the Concentration-time Curve (AUC) of AMG 355 [ Time Frame: Up to 85 days ]
  4. Confirmed Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). [ Time Frame: Up to 2 years ]
  5. Clinical Benefit per RECIST v1.1 [ Time Frame: Up to 2 years ]
  6. Duration of Response per RECIST v1.1 [ Time Frame: Up to 2 years ]
  7. Time to Progression by RECIST v1.1 [ Time Frame: Up to 2 years ]
  8. Progression-free Survival (PFS) by RECIST v1.1 [ Time Frame: Up to 2 years ]
  9. Overall Survival [ Time Frame: Up to 2 years ]
  10. Change From Baseline in C-C motif chemokine receptor 8 (CCR8+) Expression Between Pre and On Treatment Tumor Samples [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Age ≥ 18 years at the time of signing informed consent.
  • Participants with histologically or cytologically confirmed metastatic or locally advanced solid tumors who have relapsed after and/or are refractory to or ineligible for established and available therapies with known clinical benefit at time of pre-screening:

    • Group A: NSCLC, CRC, GC, and melanoma. Additional indications may be explored in consultation with Medical Monitor.
    • Group B: NSCLC, CRC, GC. Additional indications may be explored in consultation with Medical Monitor.
  • Eastern Cooperative Oncology Group Performance status 0 or 1.
  • Life expectancy of > 3 months, in the opinion of the investigator.
  • At least 1 measurable lesion as defined by modified RECIST 1.1 guidelines. Note: this lesion must not be used for the required biopsies on the study.
  • Participants must be willing to undergo 1 or more biopsies as follows:

    • Fresh biopsy prior to enrollment is preferred or, if fresh tissue is not obtainable, an archival tumor sample may be acceptable if the sample was obtained within 6 months of enrollment and participant has not received any other treatment since sample was obtained, consult the Medical Monitor.
    • Mandatory fresh biopsy during cycle 2 (before the restaging of CT-scan) of treatment with AMG 355 (± pembrolizumab).

Note: Samples must consist of a minimum of 10 (20 preferred) freshly-cut, serially, sectioned, unstained slides. A formalin-fixed, paraffin embedded block is preferred if available, but in lieu of a block, unstained slides or fresh wet tissue is acceptable.

Key Exclusion Criteria:

  • Participant who received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137), and was discontinued from that treatment due to an immune-related adverse events.
  • Untreated or symptomatic brain metastases and leptomeningeal disease Note: participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  • Chronic intake of systemic corticosteroids (eg prednisone > 10 mg/day or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • History of organ transplantation.
  • History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • History of any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis.

Other protocol-defined inclusion/exclusion criteria apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06131398


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
United States, Kansas
Alliance for Multispecialty Research Kansas City Recruiting
Merriam, Kansas, United States, 66204
United States, Texas
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Australia, South Australia
The Queen Elizabeth Hospital Recruiting
Woodville South, South Australia, Australia, 5011
Japan
National Cancer Center Hospital East Recruiting
Kashiwa-shi, Chiba, Japan, 277-8577
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT06131398    
Other Study ID Numbers: 20220028
First Posted: November 14, 2023    Key Record Dates
Last Update Posted: May 30, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: http://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Advanced Solid Tumors
AMG 355
Pembrolizumab
Pharmacokinetics
Non-small Cell Lung Cancer (NSCLC)
Colorectal Cancer (CRC)
Gastric Cancer (GC)
Melanoma (MEL)
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action