Health TrialsbyHealthPanel

Study of SP-3164 in Relapsed or Refractory Non-Hodgkin's Lymphoma

ConditionLymphoma, Non-Hodgkin's, Adult
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSalarius Pharmaceuticals, LLC

About this trial

The purpose of this research is to help researchers find out if SP-3164 is safe and if it may be of benefit in the treatment of patients with Non-Hodgkin's lymphoma that has progressed after prior treatment, or that never responded to previous treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

require treatment in the opinion of the Investigator

received at least 2 lines of systemic therapy for B-cell NHL

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • SP-3164

    Drug

    SP-3164, an oral next generation cereblon-binding molecular glue 'protein degrader'

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Dose EscalationExperimental treatment 1 intervention
Group B: Dose OptimizationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Escalation: Characterize the Safety of SP-3164

Dose Escalation (Part 1) • To characterize the safety, dose limiting toxicities (DLTs), and maximum tolerated dose (MTD) of SP-3164

Time frame
4 months
2

Dose Escalation: Assess Dose Limiting Toxicities of SP-3164

Dose Escalation (Part 1) • To characterize the safety, dose limiting toxicities (DLTs), and maximum tolerated dose (MTD) of SP-3164

Time frame
6 months
3

Dose Escalation: Assess the Maximum Tolerated Dose of SP-3164

Dose Escalation (Part 1) • To characterize the safety, dose limiting toxicities (DLTs), and maximum tolerated dose (MTD) of SP-3164

Time frame
6 months
4

Dose Optimization: Further characterize the safety of the 2 selected doses of SP-3164 from Part 1 (dose escalation)

Dose Selection Optimization (Part 2) • To further characterize the safety of the two selected doses of SP-3164 from part 1 and determine the recommended phase 2 dose (RP2D) of SP-3164 for future studies

Time frame
6 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Salarius Pharmaceuticals, LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: