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A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

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

Sakai Mio

Amgen K.K.

Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo

clinicaltrials_japan@amgen.com

Local Contact

Amgen K.K.

Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo

+81-80-7217-8592

clinicaltrials_japan@amgen.com

Recruiting

Oct. 07, 2024

Interventional

non-randomized controlled trial

open(masking not used)

dose comparison control

single assignment

basic science

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 anti-cancer therapy for SCLC.
Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease.
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.

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.

Both

Extensive Stage Small Cell Lung Cancer

- 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

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]

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]

+81-86-235-7534

Sept. 18, 2024

Yes

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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