Solid TumorPhase 1NCT05002868
Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, in Patients With Solid Tumors
A Phase 1 study testing RP12146 in people with Solid Tumor and Extensive-stage Small-cell Lung Cancer, run by Rhizen Pharmaceuticals SA at 6 sites in 2 countries.
Trial summary
An open-label, two-part Phase I/Ib study of RP12146 in adult patients with locally advanced or metastatic solid tumors. The first part (Part 1) is a Phase I dose-escalation, 3+3 design, open-label, MTD determination study and will enroll patients who have tumors known to harbour DNA repair deficiencies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Extensive-stage Small-cell Lung Cancer, Locally Advanced Breast Cancer
- What is being tested?
- RP12146
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 5 Oct 2021to 25 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of full informed consent prior to any study-specific procedures.
- Patients must be ≥18 years of age, at the time of signing informed consent.
- Dose escalation phase, patients with histologically and/or cytologically confirmed malignant solid tumor whose disease has progressed following at least one standard therapy and who have no other acceptable standard treatment options. Tumor types will include breast, ovarian, fallopian tube, or peritoneal cancer, extensive-stage small cell lung cancer (ES-SCLC), prostate, pancreatic, colorectal gastric, biliary tract, and endometrial cancer.
- Dose-expansion phase patients with histologically and/or cytologically confirmed malignant solid tumor (breast, ovarian, fallopian tube, or peritoneal cancer, extensive-stage small cell lung cancer (ES-SCLC), with one of the documented deleterious mutations of specified HRR genes and whose disease has progressed following at least one standard therapy.
- Patients with at least one measurable lesion per RECIST version 1.1 at baseline that can be accurately assessed by CT-scan or MRI and is suitable for repeated assessment at follow up-visits.
- ECOG performance status 0 to 2.
- Use of contraception measures
Who cannot join
- Patients with HER2 positive breast cancer
- Patients receiving anticancer therapy
- Patient who has not recovered from acute toxicities of previous therapy except treatment-related alopecia.
- Prior treatment with a PARP inhibitor
- Major surgery within 4 weeks of starting study treatment or any patient who has not recovered from the effects of major surgery.
- Patient with symptomatic uncontrolled brain metastasis.
- Pregnancy and lactation
- Patients with uncontrolled disease
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Poland5 sites
SP ZOZ University Hospital in Krakow Oncology Clinic, 50 Kopernika Street
Krakow, 50 Kopernika Street
Klinika Onkologii ICZMP
Lodz, 93-338
Pratia Poznań Medical Center
Poznan
Clinical Trials Site Nasz Lekarz
Torun
Maria Skłodowska-Curie Memorial National Oncology Institute
Warsaw
About this study
Official title: A Multi-center, Open-label, Phase I/Ib Study to Assess the Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, a Poly (ADP-ribose) Polymerase (PARP) Inhibitor, in Patients With Locally Advanced or Metastatic Solid Tumors
An open-label, two-part Phase I/Ib study of RP12146 in adult patients with locally advanced or metastatic solid tumors. The first part (Part 1) is a Phase I dose-escalation, 3+3 design, open-label, MTD determination study and will enroll patients who have tumors known to harbour DNA repair deficiencies. The second part (Part 2) is a Phase Ib, dose-expansion at the MTD (or optimal dose) and will enroll patients with a confirmed deleterious HRR mutation in their tumor as identified by a central genomics testing laboratory.
- Conditions
- Solid Tumor, Extensive-stage Small-cell Lung Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, Platinum-sensitive Ovarian Cancer, Platinum-Sensitive Fallopian Tube Carcinoma
- Being tested
- RP12146
- Keywords
- PARP
- Medical subject headings
- Small Cell Lung Carcinoma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP12146Drug
starting dose of 100 mg QD
| Study group | Role | What they receive |
|---|---|---|
| RP12146 | Experimental | RP12146 will be administered orally daily (QD or BID) Receives: Drug: RP12146 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of RP12146 in patients with locally advanced or metastatic solid tumors
The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 28-day cycle of treatment
Measured: 28 days
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients will be monitored for adverse events and both related and as well as non-related adverse events will be captured during the study. All adverse events (irrespective of causality) will be reported.
Measured: 2 years
Secondary outcomes (6)
Tmax
Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of RP12146
Measured: Day 1 to Day 28
Cmax
Pharmacokinetics: Maximum Concentration (Cmax) of RP12146
Measured: Day 1 to Day 28
AUC
Pharmacokinetics: Area Under the Concentration Curve (AUC) of RP12146
Measured: Day 1 to Day 28
Overall response rate (ORR)
Sum of the percentages of Complete Response and Partial Response
Measured: 2 years
Clinical benefit rate (CBR)
Sum of the percentages of Complete response, partial response and stable disease
Measured: 2 years
Progression free survival (PFS)
It is defined as time from the first dose of study treatment to documented disease progression
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start5 Oct 2021
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhizen Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002868
- Sponsor's protocol ID
- RP12146-2101
- Status last verified
- Sep 2024
- First submitted
- 5 Aug 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Phase I/Ib Study to Assess the Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, a Poly (ADP-ribose) Polymerase (PARP) Inhibitor, in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05002868
- Acronym / sponsor ID
- RP12146-2101
- Conditions
- Solid Tumor, Extensive-stage Small-cell Lung Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, Platinum-sensitive Ovarian Cancer, Platinum-Sensitive Fallopian Tube Carcinoma
- Keywords
- PARP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Rhizen Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, two-part Phase I/Ib study of RP12146 in adult patients with locally advanced or metastatic solid tumors. The first part (Part 1) is a Phase I dose-escalation, 3+3 design, open-label, MTD determination study and will enroll patients who have tumors known to harbour DNA repair deficiencies. The second part (Part 2) is a Phase Ib, dose-expansion at the MTD (or optimal dose) and will enroll patients with a confirmed deleterious HRR mutation in their tumor as identified by a central genomics testing laboratory.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RP12146 | Experimental | Drug: RP12146RP12146 will be administered orally daily (QD or BID) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of full informed consent prior to any study-specific procedures.
- Patients must be ≥18 years of age, at the time of signing informed consent.
- Dose escalation phase, patients with histologically and/or cytologically confirmed malignant solid tumor whose disease has progressed following at least one standard therapy and who have no other acceptable standard treatment options. Tumor types will include breast, ovarian, fallopian tube, or peritoneal cancer, extensive-stage small cell lung cancer (ES-SCLC), prostate, pancreatic, colorectal gastric, biliary tract, and endometrial cancer.
- Dose-expansion phase patients with histologically and/or cytologically confirmed malignant solid tumor (breast, ovarian, fallopian tube, or peritoneal cancer, extensive-stage small cell lung cancer (ES-SCLC), with one of the documented deleterious mutations of specified HRR genes and whose disease has progressed following at least one standard therapy.
- Patients with at least one measurable lesion per RECIST version 1.1 at baseline that can be accurately assessed by CT-scan or MRI and is suitable for repeated assessment at follow up-visits.
Key exclusion criteria (8 listed)
- Patients with HER2 positive breast cancer
- Patients receiving anticancer therapy
- Patient who has not recovered from acute toxicities of previous therapy except treatment-related alopecia.
- Prior treatment with a PARP inhibitor
- Major surgery within 4 weeks of starting study treatment or any patient who has not recovered from the effects of major surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RP12146starting dose of 100 mg QD | Drug | RP12146 |
Primary outcome
Maximum tolerated dose (MTD) of RP12146 in patients with locally advanced or metastatic solid tumors
Time frame: 28 days
The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 28-day cycle of treatment
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0
Time frame: 2 years
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients will be monitored for adverse events and both related and as well as non-related adverse events will be captured during the study. All adverse events (irrespective of causality) will be reported.
6 secondary outcomes
Tmax
Time frame: Day 1 to Day 28
Cmax
Time frame: Day 1 to Day 28
AUC
Time frame: Day 1 to Day 28
Overall response rate (ORR)
Time frame: 2 years
Clinical benefit rate (CBR)
Time frame: 2 years
Progression free survival (PFS)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RP12146 in people with Solid Tumor and Extensive-stage Small-cell Lung Cancer, run by Rhizen Pharmaceuticals SA at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) of RP12146 in patients with locally advanced or metastatic solid tumors (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.