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

Amgen

Status and phase

Active, not recruiting

Phase 1

Conditions

Small Cell Lung Cancer

Treatments

Drug: Tarlatamab

Drug: AMG 404

Study type

Interventional

Funder types

Industry

Identifiers

NCT04885998

2020-005957-26 (EudraCT Number)

20200439

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

23 participants in 2 patient groups

Phase 1: Dose Exploration

Experimental group

Description:

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 combination RP2D may be identified based on emerging safety, efficacy, and pharmacodynamic data prior to reaching an maximum tolerated dose (MTD).

Treatment:

Drug: AMG 404

Drug: Tarlatamab

Phase 2: Dose Expansion

Experimental group

Description:

Participants will receive the RP2D of tarlatamab in combination with AMG 404 identified in Phase 1 (dose exploration) of the study.

Treatment:

Drug: AMG 404

Drug: Tarlatamab