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NCT05546268

Study of Oral MRT-2359 in Selected Cancer Patients

StatusActive, Not Recruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary completion moved at least 6 months later.

See at-risk trials from Monte Rosa Therapeutics, Inc

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Record History

All 31 versions: 31 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 2026 to Dec 2026 Show 4 more changesShow less
    • Eligibility criteria expanded, about 33 words
    • Primary endpoints: details revised at 1 of 2 entries
    • Secondary endpoints: details revised at 2 of 11 entries
    • Study description expanded, about 2 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 22 to 17
    v30
  3. Site details revised at 2 of 22 sitesv29
  4. Site details revised at 1 of 22 sitesv28
  5. Study sites: 20 to 22v27
Show 25 earlier versionsHide 25 earlier versions
  1. Site details revised at 4 of 20 sitesv26
  2. Site details revised at 1 of 20 sitesv25
  3. Site details revised at 2 of 20 sitesv24
  4. Site details revised at 1 of 20 sitesv23
  5. Study sites: 21 to 20v22
  6. Site details revised at 1 of 21 sitesv21
  7. Site details revised at 1 of 21 sitesv20
  8. Site details revised at 1 of 21 sitesv19
  9. Site details revised at 1 of 21 sitesv18
  10. Site details revised at 1 of 21 sitesv17
  11. Site details revised at 1 of 21 sitesv16
  12. Site details revised at 1 of 21 sitesv15
  13. Eligibility criteria expanded, about 19 wordsv14 Show 5 more changesShow less
    • Enrollment target: 135 to 174
    • Study sites: 19 to 21
    • Interventions: Oral MRT-2359 (Drug), Oral MRT-2359 (Drug), Oral MRT-2359 (Drug), Oral MRT-2359 (Drug) to Oral MRT-2359 (Drug), Oral MRT-2359 (Drug), Oral MRT-2359 (Drug), Oral MRT-2359 (Drug), Oral MRT-2359 (Drug), Oral MRT-2359 (Drug)
    • Secondary endpoints: 7 to 11
    • Study arms: 4 to 6
  14. Study sites: 20 to 19v13
  15. Site details revised at 1 of 20 sitesv12
  16. Eligibility criteria expanded, about 33 words
    • Enrollment target: 133 to 135
    • Study sites: 9 to 20
    • Start date: Oct 27, 2022 to Oct 12, 2022
    v11
  17. Study sites: 8 to 9v10
  18. Site details revised at 1 of 8 sitesv9
  19. Site details revised at 1 of 8 sitesv8
  20. Site details revised at 1 of 8 sitesv7
  21. Site details revised at 1 of 8 sitesv6
  22. Site details revised at 2 of 8 sitesv5
  23. Start date changed from estimate of Oct 2022 to Oct 27, 2022
    • Site details revised at 1 of 8 sites
    v4
  24. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 8 of 8 sites
    v3
  25. Secondary endpoints revised (7)
    • Study title shortened, about 3 words
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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
Timeframe: 28 days
Phase 2 Evaluates preliminary anti-tumor activity of MRT-2359 by overall response rate (ORR) as determined by RECIST 1.1
Timeframe: 56 days (up to approximately 24 months from screening to end of study participation

Secondary (11)

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 serious adverse events (SAEs)
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 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 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
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
Show 6 moreShow less
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)
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, AUC0inf, mean residence time, accumulation ratio, etc.
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as DCR
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as PFS
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as OS
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as PSA response

Arms and interventions

Phase 1 Dose EscalationExperimental

Patients with NSCLC, SCLC, high-grade neuroendocrine cancer of any primary site, any solid tumors with L-MYC or N-MYC amplification, or DLBCL

Phase 2 Expansion - NSCLCExperimental

Patients with NSCLC with high or low L-MYC or N-MYC expression

Phase 2 Expansion - SCLCExperimental

Patients with SCLC

Phase 2 Expansion - L-MYC or N-MYC amplified solid tumorsExperimental

Patients with L-MYC or N-MYC amplified solid tumors

Phase 2 Expansion - HR-positive, HER2-negative breast cancerExperimental

Patients with HR-positive, HER2-negative breast cancer in combination with fulvestrant

Phase 2 Expansion - Prostate CancerExperimental

Patients with prostate cancer in combination with enzalutamide

Drugs: Oral MRT-2359

Sites

17 sites in 1 country