Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Debiopharm International SA
Study ID
NCT04855656
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lunresertib — DRUG
    Oral PKMYT1 Inhibitor
  • RP-3500 — DRUG
    Oral ATR Inhibitor
  • Debio0123 — DRUG
    Oral WEE1 Inhibitor

Study Details

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.

Key Dates

Start date
Apr 30, 2021
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
464 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Lunresertib Single-Agent, Dose Escalation and Food-effect Study
    Patients receive lunresertib orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified.
  • Experimental: Phase 1: Lunresertib in combination with RP-3500, Dose Escalation Study
    Patients receive lunresertib with RP-3500 orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified.
  • Experimental: Phase 1: Lunresertib in combination with Debio 0123, Dose Escalation Study
    Patients receive lunresertib with Debio 0123 orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified.

Primary Outcome Measure

Safety and Tolerability of lunresertib either in monotherapy or in combination with RP-3500 or with Debio 0123 in patients with eligible advanced solid tumors [ Time Frame: Up to 90 days after last administration of study intervention ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
# 1019, UCLA, Westwood Cancer CenterLos AngelesCalifornia90095-
#1025, University of California San FranciscoSan FranciscoCalifornia94158-
#1012, YaleNew HavenConnecticut06520-
#1017, Mayo ClinicJacksonvilleFlorida32224-
#1002, Dana Farber Cancer InstituteBostonMassachusetts02215-
#1023, START MidwestGrand RapidsMichigan49503-
#1016, Mayo ClinicRochesterMinnesota55902-
#1011, Washington UniversitySt LouisMissouri63130-
#1032, Northwell Health Cancer InstituteNew Hyde ParkNew York11042-
#1004, Memorial Sloan Kettering Cancer InstituteNew YorkNew York10065-
#1008, Columbia UniversityNew YorkNew York10032-
#1010, University of PennsylvaniaPhiladelphiaPennsylvania19104-
#1007, Rhode Island HospitalProvidenceRhode Island02903-
#1030, Women & Infants Hospital of Rhode IslandProvidenceRhode Island02903-
#1001, The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-
#1013, The University of UtahSalt Lake CityUtah84112-
#1027, University of VirginiaCharlottesvilleVirginia22903-

Find similar trials in Los Angeles, CA

By research site
# 1019, UCLA, Westwood Cancer Center· Los Angeles, CA#1025, University of California San Francisco· San Francisco, CA#1012, Yale· New Haven, CT#1017, Mayo Clinic· Jacksonville, FL#1002, Dana Farber Cancer Institute· Boston, MA#1023, START Midwest· Grand Rapids, MI

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