Clinical trial NCT02500914: SC-002 in Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma
Official title: A Phase 1a/1b Dose Escalation and Expansion Study of Single-agent SC-002 in Subjects With Relapsed or Refractory Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Small Cell Lung Cancer
Keywords: small cell lung cancer
Lead sponsor: Stemcentrx
Sponsor class: INDUSTRY
First posted: 2015-07-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1a/1b study of SC-002 in patients with relapsed small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC). SC-002 is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody linked to a potent chemotherapy.

The purpose of this study is to assess the safety and tolerability of SC-002 at different dose levels, to determine the highest dose of SC-002 that can be given to patients with SCLC or LCNEC, to evaluate the side effects of SC-002, and to assess the anti-cancer activity of SC-002.

Detailed description: Part 1A is a dose escalation study in patients with small cell lung cancer or large cell neuroendocrine carcinoma with cytologically confirmed, limited or extensive SCLC or LCNEC that have relapsed or refractory limited or extensive disease following no more than 2 prior chemotherapy regimens.

Part 1B is an expansion study where patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in patients with SCLC or LCNEC and further characterize PK, immunogenicity and target expression and possible relationship to clinical outcome.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed SCLC (either limited or extensive disease) or LCNEC, that has relapsed from the most current treatment or was refractory to treatment
* Evidence of progressive disease during or following no more than 2 prior chemotherapy regimens
* Measurable disease as defined by RECIST
* ECOG performance status of 0 or 1
* Adequate hematological and organ function as confirmed by laboratory values
* Treatment with anticancer/investigational drugs, therapy ≤ 4 weeks prior to first dose of SC-002

Exclusion Criteria:

* Active central nervous system metastases
* Uncontrolled cardiac disease
* Positive serology for hepatitis B or hepatitis C or known HIV infection
* Presence of any condition that may increase the risks associated with study participation and interfere with the interpretation of study results

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: 6 months
measure: Number of subjects with adverse events as a measure of safety and tolerability
timeFrame: 6 months
Secondary outcomes:
measure: Pharmacokinetics of SC-002
timeFrame: Cycle 1 and 4: days 1, 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 only
measure: RECIST v1.1 assessed objective response rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Novella Clinical
name: Julia Lawrence, D.O.
role: STUDY_DIRECTOR
References:
citation: Morgensztern D, Johnson M, Rudin CM, Rossi M, Lazarov M, Brickman D, Fong A. SC-002 in patients with relapsed or refractory small cell lung cancer and large cell neuroendocrine carcinoma: Phase 1 study. Lung Cancer. 2020 Jul;145:126-131. doi: 10.1016/j.lungcan.2020.04.017. Epub 2020 May 12.