Primary (Parts 1 and 2)• To evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of tarlatamab Primary (Part 3)Evaluate safety of reduced mandatory monitoring…
ID
Source
Brief title
Condition
- Other condition
- Respiratory tract neoplasms
Synonym
Health condition
kleincellig longkanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary (Part 1 Only)
• objective response (OR) (complete response [CR] and partial response [PR])
• incidence of treatment-emergent adverse events (TEAEs)
• serum concentrations of tarlatamab
Primary (All Parts)
• OR (CR and PR)
Secondary outcome
Secondary (All parts):
1.
• duration of response (DOR)
• disease control (DC)
• duration of DC
• progression-free survival (PFS)
2.
• OR
• DOR
• DC
• duration of DC
• PFS
• overall survival (OS)
3.
• incidence of TEAEs
4.
• serum concentrations of tarlatamab
5.
• incidence of anti-tarlatamab antibody formation
Background summary
The phase 1 FIH Study 20160323 evaluating the safety, tolerability and
anti-tumor activity of tarlatamab in SCLC is currently ongoing. The available
safety and preliminary efficacy data from the dose exploration phase and the
CRS mitigation cohort (with dexamethasone) demonstrate tarlatamab is well
tolerated, with a manageable safety profile and signs of preliminary efficacy.
There are currently no approved third-line therapies for relapsed ED SCLC, and
third-line therapies used in this population typically have limited overall
survival (OS) benefit .Thus, there is an urgent unmet medical need for new
therapies in the third- and later-line setting.
A detailed description of the chemistry, pharmacology, efficacy, and safety of
tarlatamab is provided in the Investigator*s Brochure.
Please refer to section 2.2 of the protocol.
Study objective
Primary (Parts 1 and 2)
• To evaluate safety and efficacy (per Response Evaluation Criteria in Solid
Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of tarlatamab
Primary (Part 3)
Evaluate safety of reduced mandatory monitoring period in cycle 1 at selected
dose of tarlatamab
Primary (All Parts)
• Evaluate anti-tumor activity of tarlatamab as determined by objective
response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR)
Secondary (All parts):
• Evaluate anti-tumor activity of tarlatamab as determined by other measures
per RECIST 1.1 by BICR
• Evaluate anti-tumor activity of tarlatamab as assessed by ORR and other
measures per RECIST 1.1 by investigator
• Evaluate the safety and tolerability of tarlatamab
• Characterize the pharmacokinetics (PK) of tarlatamab
• Evaluate the immunogenicity of tarlatamab
Study design
Open-label, 2 part study evaluating tarlatamab monotherapy. Part 1: will
evaluate 2 dose levels of tarlatamab (10 mg or 100 mg). Part 2 will be a dose
expansion phase at the selected target dose (10 mg or 100 mg) based on an
interim analysis of Part 1. Part 3 will be conducted after completing
enrollment of Parts 1 and 2, and will enroll up to approximately 30 additional
subjects at the selected dose, with modified cycle 1 monitoring criteria.
Intervention
Tarlatamab will be administered as a short-term IV infusion every 2 weeks in a
28-day cycle as monotherapy, with the exception in C1 (D1, D8, D15).
Study burden and risks
See section E of ABR-form.
Minervum 7061
Breda 4817 ZK
NL
Minervum 7061
Breda 4817 ZK
NL
Listed location countries
Age
Inclusion criteria
o Male and female subjects (>= 18 years of age) at the time of signing the
inform consent
o Histologically or cytologically confirmed relapsed/refractory SCLC
o Subject who progressed or recurred following 1 platinum-based regimen and at
least 1 other prior line of therapy
(Note: [1] re-treatment with a platinum-based regimen is considered a second
line of therapy; [2] platinum-based regimen followed by checkpoint
inhibitor/anti-programmed death ligand 1 [PD-L1] as maintenance therapy is
considered 1 line of therapy; [3] in countries where standard of care first
line systemic treatment includes platinum
containing chemotherapy in combination with PD-L1 inhibitor, it is required
that subjects have failed PD-L1 inhibitor as part of their first line systemic
treatment or are ineligible to receive PDL1 inhibitor therapy.
For more information, see section 5.1 of the protocol.
Exclusion criteria
- Untreated or symptomatic brain metastases and leptomeningeal disease.
- Has evidence of interstitial lung disease or active, non-infectious
pneumonitis.
- Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe,
life-threatening immune-mediated adverse events or infusion-related reactions
including those that lead to permanent discontinuation while on treatment with
immuno-oncology agents.
- Unresolved toxicity from prior anti-tumor therapy, defined as not having
resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
grade 1, or to levels dictated in the eligibility criteria with the exception
of alopecia or toxicities from prior anti-tumor therapy that are considered
irreversible (defined as having been present and stable for > 21 day) which may
be allowed if they are not otherwise described in the exclusion criteria AND
there is agreement to allow by both the investigator and Amgen.
For more information, see section 5.2 of the protocol.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-002566-40-NL |
| ClinicalTrials.gov | NCT05060016 |
| CCMO | NL78140.056.21 |