SC-002 in Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma

Sponsor

Stemcentrx (Industry)

Overall Status

Terminated

CT.gov ID

NCT02500914

Collaborator

(none)

Enrollment

Locations

Arm

38.7

Duration (Months)

8.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Drug: SC-002	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Aug 23, 2018

Actual Study Completion Date :

Aug 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SC-002 Part 1A (Dose Escalation) - IV infusion; safety data will be reviewed prior to dose escalation decision. Dose escalation will complete when recommended dose (RD) is determined. RD will be the maximum tolerated dose (MTD) or lower dose that provides adequate PK exposure, immunogenicity, and preliminary evidence of antitumor activity with tolerability. Part 1B (Dose Expansion) - IV infusion; once MTD and/or RD has been determined in Part 1A, an expansion cohort of approximately 60 patients with SCLC or LCNEC will be enrolled to further characterize the safety profile and clinical activity of the RD. Patients may continue treatment until disease progression, unacceptable toxicity, or withdrawal of consent.	Drug: SC-002 SC-002 will be administered by IV infusion over approximately 30 minutes every 3 weeks

Arm

Intervention/Treatment

Experimental: SC-002

Part 1A (Dose Escalation) - IV infusion; safety data will be reviewed prior to dose escalation decision. Dose escalation will complete when recommended dose (RD) is determined. RD will be the maximum tolerated dose (MTD) or lower dose that provides adequate PK exposure, immunogenicity, and preliminary evidence of antitumor activity with tolerability. Part 1B (Dose Expansion) - IV infusion; once MTD and/or RD has been determined in Part 1A, an expansion cohort of approximately 60 patients with SCLC or LCNEC will be enrolled to further characterize the safety profile and clinical activity of the RD. Patients may continue treatment until disease progression, unacceptable toxicity, or withdrawal of consent.

Drug: SC-002

SC-002 will be administered by IV infusion over approximately 30 minutes every 3 weeks

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose [6 months]
Number of subjects with adverse events as a measure of safety and tolerability [6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Ann Arbor	Michigan	United States	48109
2	Saint Louis	Missouri	United States	63110
3	New York	New York	United States	10065
4	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

Stemcentrx

Investigators

Study Director: Julia Lawrence, D.O., Novella Clinical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stemcentrx

ClinicalTrials.gov Identifier:

NCT02500914

Other Study ID Numbers:

SCRX002-001

First Posted:

Jul 17, 2015

Last Update Posted:

Oct 5, 2018

Last Verified:

Oct 1, 2018

Keywords provided by Stemcentrx

small cell lung cancer

Additional relevant MeSH terms:

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma, Neuroendocrine

Study Results

No Results Posted as of Oct 5, 2018