Phase 2 Expansion - SCLC for High-grade Neuroendocrine Cancer of Any Primary Site

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mary Crowley Cancer Research, Dallas, TX
High-grade Neuroendocrine Cancer of Any Primary Site+11 More
Oral MRT-2359 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer of any primary site, diffuse large B-cell lymphoma (DLBCL), and tumors with L-MYC or N-MYC amplification. Patients receive escalating doses of a GSPT1 molecular glue degrader MRT-2359 to determine safety, tolerability, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of MRT-2359. Once the MTD and/or RP2D is identified, additional patients enroll to Phase 2 study, which includes molecular biomarkers stratification or selection, namely mRNA expression or amplification of L-MYC and N-MYC genes.

Eligible Conditions

  • High-grade Neuroendocrine Cancer of Any Primary Site
  • NSCLC With High or Low L-MYC or N-MYC Expression
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • SCLC With High or Low L-MYC or N-MYC Expression
  • Small Cell Lung Cancer (SCLC)
  • Phase 1
  • Phase 2
  • Tumor With L-MYC and N-MYC Amplification
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Solid Tumors With L-MYC or N-MYC Amplification

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for High-grade Neuroendocrine Cancer of Any Primary Site

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: 24 months

18 months
Phase 1 preliminary anti-tumor activity: ORR (RECIST 1.1/Revised Response Criteria for Malignant Lymphoma),duration of response for complete response(CR)/partial response(PR), disease control rate, progression-free survival, overall survival
Phase 1 safety and tolerability of MRT-2359 (orally over a 28-day cycle) by the nature, incidence, and severity of all treatment-emergent adverse events (TEAEs), including treatment-related TEAEs and SAEs
24 months
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as DoR (in patients with the best overall response of CR or PR), DCR, PFS, and OS
Phase 2 Dose Expansion evaluates the safety and tolerability of MRT-2359 administered orally over a 28-day cycle by the nature, incidence, and severity of all TEAEs, including treatment-related TEAEs and SAEs according to the NCI CTCAE, version 5.0
28 days
Phase 1 Dose Escalation characterizes the PK profile of MRT-2359 by standard primary PK parameters including, but not limited to, AUC, Cmax, tmax, and t1/2
Phase 1 Evaluates safety and tolerability of MRT-2359 over a 28-day cycle by the occurrence and frequency of dose limiting toxicities (DLTs) for determination of the MTD and/or RP2D
Phase 2 Dose Expansion further characterizes the PK profile of MRT-2359 by evaluating MRT-2359 plasma concentration to establish PK parameters including, but not limited to, Cmax, tmax, AUC0-t, AUC0-inf, mean residence time, accumulation ratio, etc.
Month 24
Phase 2 Evaluates preliminary anti-tumor activity of MRT-2359 by overall response rate (ORR) as determined by RECIST 1.1
7 days
Phase 1 Dose Escalation evaluates the effect of a high-fat meal on the relative bioavailability of MRT-2359 by standard primary PK parameters including, but not limited to, AUC and Cmax

Trial Safety

Safety Progress

1 of 3

Other trials for High-grade Neuroendocrine Cancer of Any Primary Site

Trial Design

4 Treatment Groups

Phase 2 Expansion - SCLC
1 of 4
Phase 2 Expansion - L-MYC or N-MYC amplified solid tumors
1 of 4
Phase 2 Expansion - NSCLC
1 of 4
Phase 1 Dose Escalation
1 of 4
Experimental Treatment

133 Total Participants · 4 Treatment Groups

Primary Treatment: Phase 2 Expansion - SCLC · No Placebo Group · Phase 1 & 2

Phase 2 Expansion - SCLC
Drug
Experimental Group · 1 Intervention: Oral MRT-2359 · Intervention Types: Drug
Phase 2 Expansion - L-MYC or N-MYC amplified solid tumors
Drug
Experimental Group · 1 Intervention: Oral MRT-2359 · Intervention Types: Drug
Phase 2 Expansion - NSCLC
Drug
Experimental Group · 1 Intervention: Oral MRT-2359 · Intervention Types: Drug
Phase 1 Dose Escalation
Drug
Experimental Group · 1 Intervention: Oral MRT-2359 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
Closest Location: Mary Crowley Cancer Research · Dallas, TX
Photo of Dallas  1Photo of Dallas  2Photo of Dallas  3
2021First Recorded Clinical Trial
1 TrialsResearching High-grade Neuroendocrine Cancer of Any Primary Site
19 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a solid tumor with L-MYC or N-MYC amplification.
You have a solid tumor with L-MYC or N-MYC amplification.
You have a selected advanced solid tumor or DLBCL for which there are no further standard therapeutic options available.
You have a predicted life expectancy of ≥ 3 months and an ECOG performance status ≤ 2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.