CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 464 target
Drug / intervention
Lunresertib +2 moredrug
Likely dose
Not stated in record
Key inclusion· 12
  • ✓Age ≥12 years at informed consent
  • ✓Lansky performance status ≥50% for patients ≤16 years, or ECOG 0-1 (or 2 for module 1) for patients >16 years
  • ✓Locally advanced or metastatic resistant or refractory solid tumors
  • ✓Weight ≥40 kg for patients <18 years
Key exclusion· 9
  • ✕Chemotherapy or small molecule antineoplastic agent within 21 days or <5 half-lives (whichever shorter) before study start
  • ✕History or current condition that might confound results or interfere with participation
  • ✕Pregnancy or breastfeeding
  • ✕Life-threatening illness, medical condition, active uncontrolled infection, or organ dysfunction

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT04855656Phase 1RecruitingHigh Momentum
Long Recruiting
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Phase 1/1b Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors

Debiopharm International SA·interventional·Posted Apr 22, 2021·Updated Jun 23, 2026

In Brief

A Phase 1 clinical trial evaluating Lunresertib, RP-3500, and 1 other intervention for Advanced Solid Tumor. Currently recruiting, targeting 464 participants across 22 sites in 4 countries.

Signals

Enrolling ahead of pace

Detailed Summary

The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumor
CountriesCanada, Denmark, United Kingdom, United States
Collaborators--

Timeline

Phase 1Recruiting
2022202320242025202620272028
First PostedApr 22, 2021
Enrollment StartApr 30, 2021
Primary CompletionDec 1, 2027
Study CompletionJun 1, 2028
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 5.2 years agoPrimary completion in 1.4 years

Interventions

Lunresertibdrug

Oral PKMYT1 Inhibitor

RP-3500drug

Oral ATR Inhibitor

Debio0123drug

Oral WEE1 Inhibitor