Safety, Pharmacokinetics and Anti-tumor Activity of RP121... | NCT05002868

Studies
Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, in Patients With Solid Tumors

NCT05002868

Sponsor

Rhizen Pharmaceuticals SA

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

23Actual

Phase

Phase 1

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
Platinum-Sensitive Peritoneal Cancer

Interventions

RP12146

Countries

Czechia
Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 5, 2021Actual

Primary Completion Date

Apr 25, 2024Actual

Completion Date

Apr 25, 2024Actual

First Submitted Date

Aug 5, 2021

First Submission Date that Met QC Criteria

Aug 5, 2021

First Posted Date

Aug 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2024

Last Update Posted Date

Sep 19, 2024Actual

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Label	Type	Description	Intervention Names
RP12146	Experimental	RP12146 will be administered orally daily (QD or BID)	Drug: RP12146

Name	Type	Description	Arm Group Labels	Other Names
RP12146	Drug	starting dose of 100 mg QD	RP12146

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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.	2 years

Secondary Outcomes

Measure	Description	Time Frame
Tmax	Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of RP12146	Day 1 to Day 28
Cmax	Pharmacokinetics: Maximum Concentration (Cmax) of RP12146

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria.

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Multiscan s.r.o.		Hořovice		268 31	Czechia
SP ZOZ University Hospital in Krakow Oncology Clinic, 50 Kopernika Street

ID	Term
D055752	Small Cell Lung Carcinoma
D001943	Breast Neoplasms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases