Phase 1
Completed N=23
AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
Source: ClinicalTrials.gov NCT04885998 ↗Enrolled (actual)
23
Serious AEs
48.6%
Results posted
Oct 2024
Primary outcomePrimary: Part 1: Number of Participants Who Experienced Dose-limiting Toxicity (DLT) — 0; 1; 1 Participants
Summary
The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of tarlatamab in combination with AMG 404.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Number of Participants Who Experienced Dose-limiting Toxicity (DLT) |
0; 1; 1 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
7; 5; 3; 8; 6; 5 | — |
| SECONDARY Objective Response Rate Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
57.1; 20.0; 66.7; 37.5 | — |
| SECONDARY Duration of Response Per Modified RECIST v1.1 |
NA; 6.0; 8.1; 11.2 | — |
| SECONDARY Disease Control Rate Per Modified RECIST v1.1 |
57.1; 60.0; 66.7; 50.0 | — |
| SECONDARY Progression-free Survival Per Modified RECIST v1.1 |
6.5; 3.8; 6.5; 7.4 | — |
| SECONDARY Overall Survival |
NA; NA; 6.5; NA | — |
| SECONDARY Maximum Observed Concentration (Cmax) of Tarlatamab in Combination With AMG 404 |
2.98; 8.12; 28.1; 3.29; 5.54; 21.2 | — |
| SECONDARY Trough Concentration (Ctrough) of Tarlatamab in Combination With AMG 404 |
0.380; 0.893; 6.59 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 to 336 Hours (AUC0-336) of Tarlatamab in Combination With AMG 404 |
378; 1060; 4180; 336; 621; 3950 | — |
Eligibility Criteria
Inclusion Criteria
- Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures
- Age greater than or equal to 18 years old at the same time of signing the informed consent
- Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum-based regimen
- Eastern Cooperative Oncology Group (ECOG) 0 to 1
- Participants with treated brain metastases are eligible provided they meet defined criteria
- Adequate organ function as defined in protocol
Exclusion Criteria
- History of other malignancy within the past 2 years with exceptions
- Major surgery within 28 days of first dose of tarlatamab
- Untreated or symptomatic brain metastases and leptomeningeal disease
- 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
- Participants who received prior tarlatamab therapy or prior delta-like ligand 3 (DLL3) x cluster of differentiation 3 (CD3) bispecific therapy are not eligible
- 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
- 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
- Participants with evidence of interstitial lung disease or active, non-infectious pneumonitis
- 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
- History of solid organ transplantation
- History of hypophysitis or pituitary dysfunction
- 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
Data sourced from ClinicalTrials.gov (NCT04885998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.