SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT02099058

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 in subjects with advanced solid tumors. Enrollment is closed for Arms A and D.

NCT02099058 Advanced Solid Tumors Cancer

5 Interventions

Name: Osimertinib

Description: It is administered orally everyday.

Type: Drug

Arm E (ABBV-399 plus Osimertinib)

Name: Nivolumab

Description: It is an intravenous infusion administered every 14 days.

Type: Drug

Arm D (ABBV-399 plus Nivolumab)

Name: ABBV-399

Description: It is administered by infusion in 21-day dosing cycles.

Type: Drug

Monotherapy ABBV-399 (21-day dosing cycles) Arm A (ABBV-399 plus Erlotinib)

Name: ABBV-399

Description: It is administered by infusion in 28-day dosing cycles.

Type: Drug

Arm E (ABBV-399 plus Osimertinib) Monotherapy ABBV-399 (28-day dosing cycles) Arm D (ABBV-399 plus Nivolumab)

Name: Erlotinib

Description: It is administered orally everyday.

Type: Drug

Arm A (ABBV-399 plus Erlotinib)

Primary Outcomes

Description: AUC (0-t) = Area under the serum concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.

Measure: Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)

Time: Up to 24 months

Description: Maximum observed plasma concentration (Cmax)

Measure: Maximum observed plasma concentration (Cmax)

Time: Up to 24 months

Description: Time to Cmax (Tmax)

Measure: Time to Cmax (Tmax)

Time: Up to 24 months

Measure: Terminal elimination half life

Time: Up to 24 months

Secondary Outcomes

Description: ORR is defined as the proportion of the subjects who have a complete response (CR) or partial response (PR).

Measure: Objective response rate (ORR)

Time: Up to 24 months

Description: PFS is defined as the time from the first dose date of ABBV-399 to either disease progression or death, whichever occurs first.

Measure: Progression free survival (PFS)

Time: Up to 24 months

Description: DOR is defined as the time from the subject's initial CR or PR to the time of disease progression.

Measure: Duration of overall response (DOR)

Time: Up to 24 months
Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment

There are 2 SNPs

SNPs

1 L858R

- Subject must have metastatic NSCLC with documented Epidermal Growth Factor Receptor (EGFR) mutation(s) known to be sensitive to osimertinib, including del19, L858R, G719X or L861Q. --- L858R ---

2 L861Q

- Subject must have metastatic NSCLC with documented Epidermal Growth Factor Receptor (EGFR) mutation(s) known to be sensitive to osimertinib, including del19, L858R, G719X or L861Q. --- L858R --- --- L861Q ---


HPO Nodes