A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)
- Conditions
- oat-cell carcinomaSmall Cell Lung Cancersmall-cell carcinoma10029107
- Registration Number
- NL-OMON54787
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Subject has provided informed consent prior to initiation of any study-specific
activities/procedures • Age > 18 years old at the time of signing the
informed consent • Histologically or cytologically confirmed SCLC: o Parts A,
C, D, E, F and Part G: RR SCLC who progressed or recurred following at least 1
platinum-based regimen; Note: Subjects with a diagnosis of combined small cell
carcinoma with predominant small cells (as determined by the local pathologist)
may be considered for inclusion in the dose escalation phase of part A based on
investigator discretion and after discussion with the medical monitor o Part B:
ED SCLC with ongoing clinical benefit (stable disease [SD], partial response
[PR], or complete response [CR]) following no more than 6 cycles of first-line
platinum-based chemotherapy with the last dose of chemotherapy greater then
equal to 28 days prior to the study day 1 (first-line consolidation setting).
Part B will not be opened. • Eastern Cooperative Oncology Group (ECOG)
performance status of 0-2 • Minimum life expectancy of 12 weeks • RR SCLC only:
at least 2 measurable lesions as defined per modified RECIST 1.1 within 21 days
prior to the first dose of Tarlatamab. Subjects with 1 measurable lesion may be
considered for inclusion after discussion with the Medical Monitor. • Subjects
with treated brain metastases are eligible provided they meet the following
criteria: o Definitive therapy was completed at least 2 weeks prior to the
first dose of Tarlatamab. o There is no evidence of radiographic CNS
progression following definitive therapy and by the time of study screening.
Patients manifesting progression in lesions previously treated with
stereotactic radiosurgery may still be eligible if pseudo progression can be
demonstrated by appropriate means and after discussion with the medical
monitor. o Any CNS disease is asymptomatic for at least 7 days (unless symptoms
are deemed irreversible by the investigator), the patient is off steroids for
at least 7 days (physiologic doses of steroids are permitted), and the subject
is off or on stable doses of anti-epileptic drugs for malignant CNS disease for
at least 7 days. Please refer to section 4.1 of the protocol.
History of other malignancy within the past 2 years prior to first dose of
Tarlatamab except: o Malignancy (other than in situ) treated with curative
intent and with no known active disease present for > 2 years before first
dose of Tarlatamab and felt to be at low risk for recurrence by the treating
physician. o Adequately treated non-melanoma skin cancer or lentigo maligna
without evidence of disease. o Adequately treated in situ cancer without
evidence of disease. o Prostatic intraepithelial neoplasia without evidence of
prostate cancer o Adequately treated urothelial papillary noninvasive carcinoma
• Major surgery within 28 days of first dose Tarlatamab • Untreated (includes
new lesions or progression in previously treated lesions) or symptomatic brain
metastases and leptomeningeal disease • Myocardial infarction and/or
symptomatic congestive heart failure (New York Heart Association > class II)
within 12 months of first dose of Tarlatamab • History of arterial thrombosis
(eg, stroke or transient ischemic attack) within 12 months of first dose of
Tarlatamab • Subject with symptoms and/or clinical signs and/or radiographic
signs that indicate an acute and/or uncontrolled active systemic infection
within 7 days prior to the first dose of investigational product administration
• Prior anti-cancer therapy: at least 28 days must have elapsed between any
prior anti-cancer therapy and first dose of Tarlatamab
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Monotherapy:<br /><br>For all indications:<br /><br>Primary Endpoints • Dose limiting toxicities (DLTs), treatment-emergent adverse<br /><br>events (AEs), treatment-related AEs, and clinically significant changes in<br /><br>vital signs, ECG, physical examinations, and clinical laboratory tests<br /><br><br /><br>Combination Therapy:<br /><br>Primary Endpoints:<br /><br>For subjects with RR SCLC who progressed or recurred following at least 1<br /><br>platinum based regimen:<br /><br>o DLTs), treatment-emergent AEs, treatment-related AEs, and clinically<br /><br>significant changes in vital signs, ECG, physical examinations, and clinical<br /><br>laboratory tests<br /><br><br /><br>Please see protocol section 1 for more information.</p><br>
- Secondary Outcome Measures
Name Time Method