AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

JRCT ID: jRCT2031220086

Registered date:25/05/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Small Cell Lung Cancer
• Date of first enrollment: 27/09/2021
• Target sample size: 50
• Countries of recruitment: United States,Japan,Austria,Japan,Belgium,Japan,Taiwan,Japan,Singapore,Japan
• Study type: Interventional

Intervention(s)

- Experimental: Phase 1: Dose Exploration
The recommended phase 2 target dose (RP2D) of tarlatamab in combination with AMG 404 will be estimated using a modified toxicity probability interval (mTPI-2) design. A combinationRP2D may be identified based on emerging safety, efficacy, and pharmacodynamic data prior to reaching an maximum tolerated dose (MTD).
Interventions:
-Drug: Tarlatamab
-Drug: AMG 404

- Experimental: Phase 2: Dose Expansion
Participants will receive the RP2D of tarlatamab in combination with AMG 404 identified in Phase 1 (dose exploration) of the study.
Interventions:
-Drug: Tarlatamab
-Drug: AMG 404

Outcome(s)

Primary Outcome

1. Number of Participants with a Dose Limiting Toxicity (DLT) [ Time Frame: 28 days ]
2. Number of Participants with a Treatment-emergent Adverse Event (TEAE) [ Time Frame: 24 months ]
3. Number of Participants with a Treatment-related Adverse Event [ Time Frame: 24 months ]
4. Number of Participants with a Clinically Significant Change from Baseline in Vital Signs [ Time Frame: Baseline to Month 24 ]
5. Number of Participants with a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements [ Time Frame: Baseline to Month 24 ]
6. Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests [ Time Frame: Baseline to Month 24 ]

Secondary Outcome

1. Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: 24 months ]
2. Duration of Response (DOR) [ Time Frame: 24 months ]
3. Disease Control Rate (DCR) [ Time Frame: 24months ]
4. Progression-free Survival (PFS) [ Time Frame: 24 months ]
5. Overall Survival (OS) [ Time Frame: 24 months ]
6. Maximum Observed Concentration (Cmax) of Tarlatamab in Combination with AMG 404 [ Time Frame: 24 months ]
7. Minimum Observed Concentration (Cmin) of Tarlatamab in Combination with AMG 404 [ Time Frame: 24 months ]
8. Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab in Combination with AMG 404 [ Time Frame: 24 months ]

Key inclusion & exclusion criteria

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

Include criteria

1. Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures
2. Age greater than or equal to 18 years old at the same time of signing the informed consent
3. Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum-based regimen
4. Eastern Cooperative Oncology Group (ECOG) 0 to 1
5. Participants with treated brain metastases are eligible provided they meet defined criteria
6. Adequate organ function as defined in protocol

Exclude criteria

1. History of other malignancy within the past 2 years with exceptions
2. Major surgery within 28 days of first dose of tarlatamab
3. Untreated or symptomatic brain metastases and leptomeningeal disease
4. Prior anti-cancer therapy, including anti-PD1 or anti-PDL1 antibody therapy: at least 28 days must have elapsed between any prior anti- cancer therapy and the first planned dose of tarlatamab
Exceptions:
- Participants who received prior chemotherapy must have completed at least 14 days before the first dose of tarlatamab and all treatment-related toxicity resolved to grade <= 1.
- Participants who received prior palliative radiotherapy must have completed at least 7 days before the first dose of tarlatamab
5. Participants who received prior tarlatamab therapy or prior delta-like ligand 3 (DLL3) x cluster of differentiation 3 (CD3) bispecific therapy are not eligible
6. Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents
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
8. Participants with evidence of interstitial lung disease or active, non-infectious pneumonitis
9. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab
10. History of solid organ transplantation
11. History of hypophysitis or pituitary dysfunction
12. Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted

Related Information

• Primary Sponsor: Tagashira Shuzo
• Secondary ID(s): NCT04885998