Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT06433219
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tuvusertib (M1774) — DRUG
    Tuvusertib will be administered orally.
  • Niraparib — DRUG
    Niraparib will be administered orally. If selected from Part A, Niraparib will be administered orally in combination with Tuvusertib.
  • Lartesertib (M4076) — DRUG
    Lartesertib will be administered orally. If selected from Part A, Lartesertib will be administered orally in combination with Tuvusertib

Study Details

The purpose of this study is to measure the effect and safety of treatment with tuvusertib combined with either niraparib or lartesertib in participants with epithelial ovarian cancer and to assess any differences between tuvusertib monotherapy and combination therapy. The participants will previously have progressed while treated with a poly ADP ribose polymerase (PARP) inhibitor. The primary objectives of this study are to assess the effect of the treatment in terms of overall response, i.e. whether the tumor disappears, shrinks, remains unchanged, or gets worse and safety in terms of adverse events.

Key Dates

Start date
Oct 30, 2024
Status verified
May 2026
Primary completion
Jun 14, 2026
Completion
Jun 14, 2026

Study Design

Enrollment
63 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A, Arm 1: Tuvusertib with Niraparib
    In Part A, participants will be randomized to one of 2 arms to receive tuvusertib in combination with either niraparib or lartesertib.
  • Experimental: Part A, Arm 2: Tuvusertib with Lartesertib
    In Part A, participants will be randomized to one of 2 arms to receive tuvusertib in combination with either niraparib or lartesertib.
  • Experimental: Part B (dose optimization), dosing regimen 1 :Tuvusertib+Niraparib or Tuvusertib +Lartesertib
    In Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy.
  • Experimental: Part B (dose optimization), dosing regimen 2: Tuvusertib + Niraparib or Tuvusertib + Lartesertib
    In Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy.
  • Experimental: Part B: Tuvusertib Monotherapy
    In Part B, the most favorable combination treatment from Part A will be further explored at 2 different dosing regimens and compared to tuvusertib monotherapy.

Primary Outcome Measure

Part A and Part B: Confirmed Objective Response (OR) According to RECIST v1.1 as Assessed by Investigator [ Time Frame: Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205-
University of California San Francisco - UCSF Medical CenterSan FranciscoCalifornia94158-
Centricity Research Cancer Center - DBA CRRI John B. Amos Cancer Center ResearchColumbusGeorgia31904-
University of Chicago Comprehensive Cancer Center at Silver Cross - Carolyn J. Czerkies PavilionChicagoIllinois60637-
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-
Icahn School of Medicine at Mount Sinai PRIME - Mount Sinai - PRIMENew YorkNew York10029-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Next Oncology - VirginiaFairfaxVirginia22031-
Virginia Cancer Specialists, PCFairfaxVirginia22031-

Find similar trials in Little Rock, AR

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Arkansas for Medical Sciences· Little Rock, ARUniversity of California San Francisco - UCSF Medical Center· San Francisco, CACentricity Research Cancer Center - DBA CRRI John B. Amos Cancer Center Research· Columbus, GAUniversity of Chicago Comprehensive Cancer Center at Silver Cross - Carolyn J. Czerkies Pavilion· Chicago, ILUniversity of Michigan Rogel Cancer Center· Ann Arbor, MIIcahn School of Medicine at Mount Sinai PRIME - Mount Sinai - PRIME· New York, NY

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