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

JRCT ID: jRCT2031240106

Registered date:24/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced Solid Tumors
• Date of first enrollment: 07/03/2024
• Target sample size: 515
• Countries of recruitment: Australia,Japan,Korea,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Experimental: Group A: AMG 355 monotherapy
Specified dose on specified days
Intervention: Drug: AMG 355

Experimental: Group B: AMG 355 and pembrolizumab
Specified dose on specified days
Interventions:
Drug: AMG 355
Drug: Pembrolizumab

Outcome(s)

Primary Outcome

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

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 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Age >= 18 years at the time of signing informed consent.
2. 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.
3. Eastern Cooperative Oncology Group Performance status 0 or 1.
4. Life expectancy of > 3 months, in the opinion of the investigator.
5. 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.
6. 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.

Exclude criteria

1. 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.
2. 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.
3. 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.
4. 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.
5. History of organ transplantation.
6. History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
7. 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.

Related Information

• Primary Sponsor: Iizumi Sakura
• Secondary ID(s): NCT06131398