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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06131398
• Other study ID #: 20220028
• Status: Recruiting
• Phase: Phase 1
• Start date: March 7, 2024
• Est. completion date: February 8, 2028

Study information

• Verified date: June 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 515
• Est. completion date: February 8, 2028
• Est. primary completion date: February 8, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• AMG 355
Short-term intravenous (IV) infusion
• Pembrolizumab
Short-term IV infusion

Locations

Country	Name	City	State
Australia	The Queen Elizabeth Hospital	Woodville South	South Australia
Japan	National Cancer Center Hospital East	Kashiwa-shi	Chiba
Korea, Republic of	Asan Medical Center	Seoul
Poland	Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy	Warszawa
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United States	City of Hope National Medical Center	Duarte	California
United States	Alliance for Multispecialty Research Kansas City	Merriam	Kansas
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Japan,  Korea, Republic of,  Poland,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experience a Dose Limiting Toxicity (DLT)		Day 1 to Day 21
Primary	Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)	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.	Up to 2 years
Primary	Number of Participants Who Experience a Treatment-related AE		Up to 2 years
Secondary	Maximum Observed Serum Concentration (Cmax) of AMG 355		Up to 85 days
Secondary	Minimum Observed Serum Concentration (Cmin) of AMG 355		Up to 85 days
Secondary	Area Under the Concentration-time Curve (AUC) of AMG 355		Up to 85 days
Secondary	Confirmed Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).		Up to 2 years
Secondary	Clinical Benefit per RECIST v1.1		Up to 2 years
Secondary	Duration of Response per RECIST v1.1		Up to 2 years
Secondary	Time to Progression by RECIST v1.1		Up to 2 years
Secondary	Progression-free Survival (PFS) by RECIST v1.1		Up to 2 years
Secondary	Overall Survival		Up to 2 years
Secondary	Change From Baseline in C-C motif chemokine receptor 8 (CCR8+) Expression Between Pre and On Treatment Tumor Samples		Up to 2 years

External Links

•   AmgenTrials clinical trials website