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PARP Inhibitor

RP-3500 + Olaparib for Chronic Lymphocytic Leukemia (CORONADO CLL Trial)

Phase 1 & 2
Recruiting
Led By Boyu Hu, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Immunophenotype consistent with CLL
Must not have
Prior history of certain malignancies
Recent stem cell transplant or active graft-versus-host disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Summary

This trial is testing a combination of camonsertib and olaparib in patients with a specific type of blood cancer who have not responded to other treatments. The drugs aim to block the cancer cells' ability to fix their damaged DNA, causing them to die. Olaparib is an oral medication that blocks DNA repair pathways and has shown promising results in various cancers, including breast, ovarian, and prostate cancers.

Who is the study for?
Adults (≥18 years) with chronic lymphocytic leukemia that's relapsed or refractory after at least two treatments. They must have specific genetic mutations, adequate organ function, and no major health issues like severe liver impairment or active central nervous system involvement. Participants need to be able to swallow pills, follow the study schedule, and use effective contraception.
What is being tested?
The trial is testing a combination of two drugs: RP-3500 and Olaparib in patients whose leukemia cells show deficiencies in DNA damage repair pathways. It's an open-label phase Ib/II study which means everyone gets the treatment combo and researchers track its effects.
What are the potential side effects?
While not explicitly listed here, common side effects for cancer drugs like RP-3500 and Olaparib may include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, diarrhea or constipation. Specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My blood cancer type matches CLL.
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I can swallow pills.
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I have been diagnosed with chronic lymphocytic leukemia.
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My condition did not improve after 2 previous treatments.
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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had cancer before.
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I recently had a stem cell transplant or I have active graft-versus-host disease.
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I have had lung inflammation or lung disease in the past.
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I have a serious liver condition.
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I am not taking any strong medication that affects liver enzymes or certain drug transporters.
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I have a condition that affects my stomach or intestines.
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My condition has progressed to Richter's Transformation.
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My chronic lymphocytic leukemia (CLL) has spread to my brain.
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I need steroids for my health condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate (ORR)
Rate of dose-limiting toxicities (DLTs) during the DLT evaluation period
Secondary study objectives
DoR as defined as the interval of time from the date of initial documented response (PR or better as per 2018 iwCLL criteria for response) to the time of progression
OS as defined as the time from registration until death from any cause
Progression-free survival (PFS) as defined as the time from study drug initiation to the time documented disease progression (as assessed by 2018 iwCLL criteria) or death from any cause
+1 more

Side effects data

From 2022 Phase 3 trial • 220 Patients • NCT03106987
39%
Nausea
24%
Asthenia
18%
Fatigue
18%
Anaemia
14%
Diarrhoea
12%
Constipation
11%
Vomiting
11%
Abdominal pain
9%
Abdominal pain upper
9%
Dyspnoea
8%
Headache
7%
Cough
5%
Dry mouth
5%
Leukopenia
5%
Dizziness
5%
Neutropenia
5%
Muscle spasms
5%
Blood creatinine increased
4%
Alanine aminotransferase increased
4%
Dysgeusia
3%
Decreased appetite
3%
Flatulence
3%
Lymphopenia
3%
Insomnia
3%
Paraesthesia
3%
Aspartate aminotransferase increased
3%
Thrombocytopenia
3%
Dyspepsia
3%
Dry skin
3%
Platelet count decreased
3%
Contusion
3%
Blood urea increased
3%
COVID-19 pneumonia
3%
Influenza
3%
Skin infection
3%
Urinary tract infection
3%
Hot flush
3%
Hypertension
3%
Back pain
1%
Gingivitis
1%
Oesophageal squamous cell carcinoma
1%
Bell's palsy
1%
Aphthous ulcer
1%
Neurotoxicity
1%
Syncope
1%
Dysphonia
1%
Chest pain
1%
Oedema peripheral
1%
Creatinine renal clearance decreased
1%
Cystitis
1%
Rhinorrhoea
1%
Illness
1%
Mucosal inflammation
1%
Fall
1%
Hypotension
1%
Oropharyngeal pain
1%
Pruritus
1%
Hypercholesterolaemia
1%
Gastrooesophageal reflux disease
1%
Sluggishness
1%
COVID-19
1%
Tinnitus
1%
Blood albumin decreased
1%
Vertigo
1%
Weight decreased
1%
Pyrexia
1%
Radius fracture
1%
Neuropathy peripheral
1%
Eye irritation
1%
Palpitations
1%
Alopecia
1%
Genital herpes
1%
Neutrophil count decreased
1%
Hypothyroidism
1%
Tremor
1%
Gamma-glutamyltransferase increased
1%
Gastroenteritis cryptosporidial
1%
Rash
1%
Lymphocyte count decreased
1%
Bronchitis
1%
Dry eye
1%
Pleural infection
1%
Rhinitis
1%
Sinusitis
1%
Hypermagnesaemia
1%
Hypocalcaemia
1%
Hypokalaemia
1%
Hypomagnesaemia
1%
Hyponatraemia
1%
Sciatica
1%
Peripheral sensory neuropathy
1%
Polyneuropathy
1%
Tachycardia
1%
Odynophagia
1%
Stomatitis
1%
Rash maculo-papular
1%
Arthritis
1%
Bone pain
1%
Flank pain
1%
Hypercreatinaemia
1%
Muscular weakness
1%
Musculoskeletal pain
1%
Myalgia
1%
Osteoporosis
1%
Blood alkaline phosphatase increased
1%
Blood bilirubin increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib (BRCA1/2 +ve)
Placebo (BRCA1/2 +ve)
Olaparib (BRCA1/2 -ve)
Placebo (BRCA1/2 -ve)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Phase Ib: Dose EscalationExperimental Treatment1 Intervention
To assess the MTD of RP-3500 in combination with olaparib
Group II: Phase II: Dose Expansion Enrichment CohortExperimental Treatment1 Intervention
All subjects enrolled into the enrichment cohort must have a del(11q) and/or ATM mutation
Group III: Phase II: Dose Expansion Eligible Subjects CohortExperimental Treatment1 Intervention
Cohort will include all other eligible subjects for Dose Expansion.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Chronic Lymphocytic Leukemia (CLL) include targeted therapies such as PARP inhibitors and agents targeting DNA damage repair (DDR) pathways. Olaparib, a PARP inhibitor, works by preventing cancer cells from repairing their DNA, leading to cell death, especially in cells with existing DNA repair deficiencies. RP-3500, likely a novel DDR pathway agent, would similarly exploit the impaired DNA repair mechanisms in CLL cells. These treatments are crucial for CLL patients as they offer a more precise approach, targeting the cancer cells' vulnerabilities while sparing normal cells, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.
Poly(ADP-ribose) polymerase inhibitor CEP-8983 synergizes with bendamustine in chronic lymphocytic leukemia cells in vitro.PARP1 expression, activity and ex vivo sensitivity to the PARP inhibitor, talazoparib (BMN 673), in chronic lymphocytic leukaemia.

Find a Location

Who is running the clinical trial?

Repare TherapeuticsIndustry Sponsor
9 Previous Clinical Trials
1,279 Total Patients Enrolled
University of UtahLead Sponsor
1,127 Previous Clinical Trials
1,793,158 Total Patients Enrolled
Boyu Hu, MDPrincipal InvestigatorHuntsman Cancer Institute
1 Previous Clinical Trials
18 Total Patients Enrolled
~11 spots leftby Aug 2025
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