Small Cell Lung Cancer
Conditions
Keywords
small cell lung cancer
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.
Interventions
DRUGSC-002
SC-002 will be administered by IV infusion over approximately 30 minutes every 3 weeks
Sponsors
Stemcentrx
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose | 6 months |
| Number of subjects with adverse events as a measure of safety and tolerability | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of SC-002 | Cycle 1 and 4: days 1, 2, 4, 8, 15; Cycles 2, 3, and 5: day 1 only | Standard PK variables to be assessed include AUC, Tmax, Cmax, Ctrough, T1/2, CL, Vss |
| RECIST v1.1 assessed objective response rate | 6 months | — |
Countries
United States
Outcome results
None listed