RP-3500 and Olaparib in DNA Damage Repair Pathway Deficient Relapsed/Refractory Chronic Lymphocytic Leukemia

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT05405309
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • RP-3500 — DRUG
    RP-3500 is a highly potent and selective Ataxia telangiectasia and Rad3 related inhibitor (ATRi) and has demonstrated significant preclinical activity.
  • Olaparib — DRUG
    Olaparib is an oral poly (adenosine diphosphate-ribose) polymerase inhibitor (PARPi) that inhibits PARP's function by competitively binding to the Nicotinamide adenine dinucleotide (NAD+) binding site, which PARP requires as a cofactor to operate.

Study Details

This is an open-label, multicenter, phase Ib/II study of the combination of RP-3500 and olaparib in Relapsed/Refractory Chronic Lymphocytic Leukemia (R/R CLL) patients with DDR deficiencies.

Key Dates

Start date
Sep 23, 2022
Status verified
May 2025
Primary completion
Oct 24, 2023
Completion
Jan 10, 2025

Study Design

Enrollment
5 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ib: Dose Level -1
    To assess the MTD of RP-3500 in combination with olaparib. Patients will receive RP-3500 40mg daily and olaparib 100mg BID. Both drugs are given with intermittent dosing of 2 days per week and each cycle is 21 days.
  • Experimental: Phase Ib: Dose Level 1
    To assess the MTD of RP-3500 in combination with olaparib. Patients will receive RP-3500 50mg daily and olaparib 100mg BID. Both drugs are given with intermittent dosing of 2 days per week and each cycle is 21 days.
  • Experimental: Phase Ib: Dose Level 2
    To assess the MTD of RP-3500 in combination with olaparib. Patients will receive RP-3500 80mg daily and olaparib 100mg BID. Both drugs are given with intermittent dosing of 2 days per week and each cycle is 21 days.
  • Experimental: Phase Ib: Dose Level 3
    To assess the MTD of RP-3500 in combination with olaparib. Patients will receive RP-3500 80mg daily and olaparib 150mg BID. Both drugs are given with intermittent dosing of 2 days per week and each cycle is 21 days.
  • Experimental: Phase II: Dose Expansion Enrichment Cohort
    Subjects enrolled into the enrichment cohort must have a del(11q) and/or ATM mutation.
  • Experimental: Phase II: Dose Expansion Eligible Subjects Cohort
    Cohort will include all other eligible subjects for Dose Expansion.
  • Experimental: Phase Ib (prior to Aug2023 amendment): Original Dose Level 1
    To assess the MTD of RP-3500 in combination with olaparib. Before the Aug2023 amendment, patients enrolled at Dose Level 1 received RP-3500 40mg daily and olaparib 100mg BID. Both drugs were given with intermittent dosing of 3 days per week and each cycle was 28 days.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Camonsertib (RP-3500) in Combination With Olaparib [ Time Frame: up to 28 days after initiation of study drug ]

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute at the University of UtahSalt Lake CityUtah84112-

Find similar trials in Salt Lake City, UT

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Huntsman Cancer Institute at the University of Utah· Salt Lake City, UT

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