Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

JRCT ID: jRCT2061240070

Registered date:18/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Extensive Stage Small Cell Lung Cancer
• Date of first enrollment: 07/10/2024
• Target sample size: 100
• Countries of recruitment: United States,Japan,Australia,Japan
• Study type: Interventional

Intervention(s)

- Experimental: Part 1 Dose Exploration
Tarlatamab will be administered as a SC injection in Part 1.
Interventions: Drug: Tarlatamab

- Experimental: Part 2 Dose Expansion
Following the selection of a SC dosing regimen in Part 1, tarlatamab will be administered in Part2 at the dose deemed safe and tolerable in Part 1.
Interventions: Drug: Tarlatamab

Outcome(s)

Primary Outcome

1. Number of Participants with Dose-limiting toxicities (DLTs) [Time Frame: Up to day 21]
2. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Up to approximately 24 months]
3. Number of Participants with Changes in Vital Signs [Time Frame: Up to approximately 24 months]
4. Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests [Time Frame: Up to approximately 24 months]

Secondary Outcome

1. Maximum Serum Concentration (Cmax) of Tarlatamab [Time Frame: Up to approximately 12 months]
2. Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab [Time Frame: Up to approximately 12months]
3. Time to Cmax (Tmax) of Tarlatamab [Time Frame: Up to approximately 12 months]
4. Area Under the Concentration-time Curve (AUC) of Tarlatamab [Time Frame: Up to approximately 12months]
5. Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [Time Frame: Up to approximately 24 months]
6. Duration of Response (DOR) per RECIST 1.1 [Time Frame: Up to approximately 24 months]
7. Time to Response (TTR) per RECIST 1.1 [Time Frame: Up to approximately 24 months]
8. Progression-free Survival (PFS) per RECIST 1.1 [Time Frame: Up to approximately 24 months]
9. Time to Progression per RECIST 1.1 [Time Frame: Up to approximately 24 months]
10. Time to Subsequent Therapy [Time Frame: Up to approximately 24 months]
11. Overall Survival (OS) [Time Frame: Up to approximately 24 months]
12.Number of Participants with Anti-tarlatamab Antibody Formation [Time Frame: Up to approximately 24months]

Key inclusion & exclusion criteria

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

Include criteria

1. Participants >= 18 years of age (or >= legal adult age within country if it is older than 18 years) at time of signing informed consent.
2. Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based regimen.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
4. Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver).
5. Participants must be able to have SC injections administered in the abdomen (and/or thigh).
6. Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.

Exclude criteria

1. Participants that have received prior DLL3 targeted therapy.
2. Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids.
Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment).
3. Participants with leptomeningeal disease.
4. Participants with baseline oxygen requirement.

Related Information

• Primary Sponsor: Sakai Mio
• Secondary ID(s): NCT06598306