Trials Sponsors Conditions Drugs Pricing

Conditions

Lymphoma, Non-Hodgkin's, Adult

Outcome Measures

Primary Outcomes (5)

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
4 months
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
6 months
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
6 months
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
6 months
Dose Optimization: Determine the recommended phase 2 dose of SP-3164 for future studies
• 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
6 months

Study Arms (2)

Dose Escalation

EXPERIMENTAL

For part 1 dose escalation, one patient per dose cohort will be initially recruited (accelerated titration dose-escalation, single-patient cohorts/dose level) for the first two dose levels or until the first instance of a ≥ Grade 2 toxicity (excluding Grade 2 neutropenia and lymphopenia and adverse events unequivocally due to the underlying disease or to an extraneous cause), or dose-limiting toxicity (DLT), whichever occurs earlier. Further cohorts will be recruited in blocks of three patients, i.e., 3+3 dose escalation design.

Drug: SP-3164

Dose Optimization

EXPERIMENTAL

For part 2 dose selection optimization, two dose levels will be selected by the Safety Review Committee (SRC) based on review of all available data on safety, tolerability, PK, PD, and preliminary efficacy from part 1. The dose selection optimization will include only patients with R/R DLBCL and will randomize 1:1 approximately 30 new patients at the two selected dose levels (15 patients to each of the two selected dose levels) before declaring the RP2D. Assessment of PK/PD of SP-3164 will be included in part 2 dose selection optimization.

Interventions

SP-3164Drug

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

Dose EscalationDose Optimization

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis (WHO 2016 criteria) of R/R B-cell NHL in dose escalation (part 1) and limited to R/R DLBCL in dose selection optimization (part 2) confirmed by biopsy and immunophenotyping
Dose escalation: at time of enrollment, R/R B-cell NHL patients per WHO 2016 criteria including DLBCL (including low grade transformed lymphoma), mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma and must:

Sponsors & Collaborators

Salarius Pharmaceuticals, LLC
Industrylead

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Rebecca Griffith-Eskew

CONTACT

+1 254 265 2782 reskew@salariuspharma.com

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 7, 2023

Study Start

March 15, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

Patients with chronic lymphocytic leukemia, high grade B-cell lymphoma, or Richter's syndrome
Patients who have not recovered to Grade 1 toxicity or baseline due to any previous anticancer therapy according to the NCI CTCAE v5.0, excluding Grade 2 alopecia. Lymphopenia ≤ Grade 2 is allowed
Patients with primary central nervous system (CNS) lymphoma or active CNS or meningeal lymphomatous involvement
Persistent diarrhea or malabsorption of ≥ Grade 2 despite medical management
Impaired cardiac function or clinically significant cardiac disease, including symptomatic congestive heart failure, left ventricular ejection fraction (LVEF) \< 50%, unstable angina pectoris or cardiac arrhythmias, baseline QTc (Fridericia) \> 450 milliseconds, long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, myocardial infarct within 6 months of study enrollment, clinically significant pericardial disease
Solid organ transplant recipient
Allogeneic stem cell transplantation (SCT) recipient
Autologous SCT recipient \<100 days from Cycle 1 Day 1 or otherwise not fully recovered from SCT-related toxicity
Completion of CAR-T therapy \< 90 days from Cycle 1 Day 1
Systemic immunosuppressants and chronic systemic corticosteroids (at doses ≥ 10 mg/day of prednisone or equivalent) are prohibited
Malignant disease, other than that being treated in this study. Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) who have undergone potentially curative therapy are not excluded. Other exceptions include malignancies that were treated curatively and have not recurred within 3 years prior to Cycle 1 Day 1 and any malignancy considered indolent and that has never required therapy
Other concurrent severe or uncontrolled concomitant medical conditions that might cause unacceptable safety risks or compromise compliance with the protocol
Pregnant and breastfeeding women
Known history of HIV-positivity; known hepatitis B or hepatitis C virus infection
Men and women of child-bearing potential unwilling to use adequate contraception according to study protocol

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Study Arms (2)

Dose Escalation

Dose Optimization

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Study Arms (2)

Dose Escalation

Dose Optimization

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record