Overview
Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, a PARP Inhibitor, in Patients With Locally Advanced or Metastatic Solid Tumors
Status:
Recruiting
Recruiting
Trial end date:
2023-08-01
2023-08-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Rhizen Pharmaceuticals SA
Criteria
Inclusion Criteria.1. Provision of full informed consent prior to any study-specific procedures.
2. Patients must be ≥18 years of age, at the time of signing informed consent.
3. 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.
4. 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.
5. 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.
6. ECOG performance status 0 to 2.
7. Use of contraception measures
Exclusion Criteria:
1. Patients with HER2 positive breast cancer
2. Patients receiving anticancer therapy
3. Patient who has not recovered from acute toxicities of previous therapy except
treatment-related alopecia.
4. Prior treatment with a PARP inhibitor
5. Major surgery within 4 weeks of starting study treatment or any patient who has not
recovered from the effects of major surgery.
6. Patient with symptomatic uncontrolled brain metastasis.
7. Pregnancy and lactation
8. Patients with uncontrolled disease