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Report for Clinical Trial NCT02092909

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase 1/2 Open-Label, Multiple-dose, Dose-escalation Study to Evaluate the Safety and Tolerability of IMO-8400 in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia

Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 90% of the patients with Waldenström's macroglobulinemia. MYD88 is a key linker protein in the signaling pathway of Toll Like Receptors (TLRs) 7, 8, and 9, and IMO-8400 is an oligonucleotide specifically designed to inhibit TLRs 7,8, and 9. The scientific hypothesis for use of IMO-8400 to treat patients with Waldenström's macroglobulinemia depends on the inhibition of mutant MYD88 signaling in the TLR pathway, thereby interrupting the proliferation of cell populations responsible for the propagation of the disease.

NCT02092909 Waldenstrom's Macroglobulinemia
MeSH:Waldenstrom Macroglobulinemia
HPO:Monoclonal immunoglobulin M proteinemia

1 Interventions

Name: IMO-8400

Description: IMO-8400 at escalating dose levels by subcutaneous injection
Type: Drug
Group Labels: 1

IMO-8400 at escalating dose levels


Primary Outcomes

Description: Safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia: Assessment of adverse events

Measure: Safety and Tolerability of IMO-8400 in Patients With Waldenstrom's Macroglobulinemia

Time: Up to 24 weeks

Secondary Outcomes

Description: Best Overall Response using criteria from the VIth International Workshop in Waldenstrom's Macroglobulinemia

Measure: Best Overall Response

Time: Up to 24 weeks

Description: To identify an appropriate dose of IMO-8400 for further clinical evaluation via evaluation of DLT at each dose level

Measure: Identify the Number of Patients Experiencing DLTs at Each Dose Level

Time: 28 days

Description: Pharmacokinetics of escalating dose levels of IMO 8400 administered by SC injection - Cmax.

Measure: Pharmacokinetics of Escalating Dose Levels of IMO 8400 Administered by SC Injection - Cmax.

Time: Cycle 1 Week 1 Day 1: Samples were obtained pre-dose (within 1 hr prior to injection) and post-dose at 1 hr (+/-5 min), 2 hrs (+/-10 min) and 4 hrs (+/-15 min)

Description: Pharmacokinetics of escalating dose levels of IMO 8400 administered by SC injection - AUC0-t (hr*ng/mL) .

Measure: Pharmacokinetics of Escalating Dose Levels of IMO 8400 Administered by SC Injection - AUC0-t (hr*ng/mL)

Time: Cycle 1 Week 1 Day 1: Samples were obtained pre-dose (within 1 hr prior to injection) and post-dose at 1 hr (+/-5 min), 2 hrs (+/-10 min) and 4 hrs (+/-15 min)

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L265P

Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 90% of the patients with Waldenström's macroglobulinemia. --- L265P ---



HPO Nodes


HPO: