DeLLphi-310 - A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With YL201 With or Without Anti-PD-L1 in Subjects With Extensive Stage Small Cell Lung Cancer.

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1, I B

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent.
- Participants with histologically or cytologically confirmed ES-SCLC.
- For Parts 1 and 2, participant must have ES-SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.
- For Part 3, participants must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, etoposide, and PD-(L)1 inhibitor in the first-line setting.
- At least 1 measurable lesion as defined by RECIST 1.1.
- Participants must have adequate organ function (cardiac, pulmonary, kidney, bone marrow, and liver).

Criteri di esclusione: 

- Prior delta-like ligand 3 (DLL3) or B7 homolog 3 (B7-H3) targeted therapy.
- Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
- Symptomatic central nervous system (CNS) metastases. Note: Participants with asymptomatic brain metastases are eligible as defined in the protocol.
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Baseline requirement of supplemental oxygen.

Trattamento sperimentale: 

Dose Exploration (Part 1)
Multiple dose levels of YL201 will be explored in combination with tarlatamab administered intravenously (IV) at a fixed dose using one-step dosing.

Dose Expansion (Part 2)
YL201 will be administered at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV at a fixed dose.

Triplet Combination (Part 3)
YL201 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (atezolizumab or durvalumab) administered IV at a fixed dose.

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.

Centri partecipanti

Nord Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-515903-21-00 - NCT06898957

Data di inserimento: 18.11.2025

Promotore

Amgen

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na