Phase 1/2 Modular Dose Escalation With Cohort Expansion of CP-506 (HAP) in Patients With Solid Tumor Types With High Incidence of HRD/FAD in Monotherapy or With Carboplatin or Patients With Solid Tumour and OPD Receiving ICI

Who is this study for? Patients with Solid Tumor
What treatments are being studied? CP-506
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

A modular, first time in human, open label, multiple dose, accelerated escalation with cohort expansion study of the safety and pharmacokinetics of intravenous infusion of CP-506, a tumor agnostic Hypoxia Activated Prodrug in patients with HRD/FAD solid tumours or tumor types with high incidence of HRD/FAD in monotherapy or in combination with carboplatin or patients with solid tumour and oligoprogressive disease receiving immune checkpoint inhibitors (ICI): a phase I-IIa clinical trial

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female, aged 18 years or more at the time of signing the informed consent

• Be willing and able to provide written informed consent for the trial

• Life expectancy of at least 3 months

• Be willing to have a biopsy collection procedure

• ECOG Performance status \<= 2

• Must have adequate organ and bone marrow function, defined as the following:

‣ 1. ANC ≥ 1500 µL 6.2. Hemoglobin ≥ 9.0 g/dL 6.3. Platelets ≥ 100 000 µL 6.4. Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \>1.5 × ULN 6.5. AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases) 6.6. Creatinine ≤ 1.5 × ULN 6.7. Coagulation: INR ≤ 1.5 × ULN (or within therapeutic ranges for participants on anticoagulant treatment)

• Measurable disease on CT scan (RECIST 1.1)

• If female, not pregnant, not breastfeeding, and at least one of the following conditions applies:

‣ 1. Not a woman of childbearing potential (WOCBP) 8.2. A WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment and shows a negative pregnancy test before the start of the treatment

• If male, must agree to use contraception during the treatment period and for at least 4 weeks after the last dose of study treatment

⁃ Able and willing to comply with the protocol Module 1 - monotherapy

⁃ Have histologically or cytologically-confirmed advanced or metastatic solid tumour for whom no standard of care or known effective treatment options are available

⁃ Have indications of Homologous Recombination (HR) or Fanconi Anaemia (FA) DNA damage repair defects, based on hereditary cancer diagnostics (e.g. BRCA1/2 carriers), dedicated HRD genomic assays (including exome-sequencing) from liquid or tissue biopsies. Presence of such a defect must have been established via a tissue based next generation sequencing test, performed --in a CAP/CLIAcertified (or comparable local or regional certification) laboratory, or via a germline test from one of the following approved providers: Myriad Genetics; Invitae; Ambry; Quest; Color Genomics; MSKCC-IMPACT; GeneDx; Foundation Medicine OR Have cancers with an increased incidence of HRD/FAD: ovarian (41%), breast (18%), pancreas (10%), prostate (9%), and head and neck (5%) OR Patients who were previously responsive to alkylating agent (Partial Response/Complete Response according to RECIST criteria).

⁃ Module 2 - Carboplatin combination

⁃ Patient must be eligible to carboplatin treatment.

⁃ Have histologically or cytologically-confirmed advanced or metastatic solid tumour for whom no standard of care or known effective treatment options are available.

⁃ Receive carboplatin as standard of care: triple negative breast cancer or ovarian cancer.

⁃ Module 3 - ICI combination

⁃ Have histologically or cytologically-confirmed advanced or metastatic solid tumour

⁃ Receiving immune checkpoint inhibitor (ICI) monotherapy as standard of care for at least 6 months prior to the beginning of the study and who are oligoprogressive. Oligoprogression disease is defined as localized treatment failure at one or two anatomic sites, with one to five progressive and measurable (according to RECIST 1.1) lesions, either new or with ≥ 20% growth of their longest diameter (short-axis in lymph nodes), while other tumor manifestations could shrink or grow less than 20% in diameter

Locations
Other Locations
Belgium
Institut Jules Bordet
NOT_YET_RECRUITING
Brussels
UZ Gent
NOT_YET_RECRUITING
Ghent
Netherlands
Academisch Ziekenhuis Maastricht (Leading Centre)
RECRUITING
Maastricht
Erasmus MC
RECRUITING
Rotterdam
Spain
Institut Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
Contact Information
Primary
Ludwig Dubois, PhD
ludwig.dubois@maastrichtuniversity.nl
+31433882909
Time Frame
Start Date: 2023-05-30
Estimated Completion Date: 2027-05
Participants
Target number of participants: 126
Treatments
Experimental: Module 1A Monotherapy Multiple Ascending Dose
Multiple ascending dose cohorts dosing CP-506 monotherapy in all patients up to a maximally tolerated or maximally feasible dose Intervention: Drug: CP-506
Experimental: Module 1B Monotherapy Dose Expansion Cohort
Expansion cohort dosing CP-506 monotherapy in patients at recommended phase 2 dose (RP2D) Intervention: Drug: CP-506
Experimental: Module 2A Combination with carboplatin Multiple Ascending Dose
Multiple ascending dose cohorts dosing CP-506 in combination with carboplatin in all patients up to a maximally tolerated or maximally feasible dose Intervention: Drug: CP-506
Experimental: Module 2B Combination with carboplatin Dose Expansion Cohort
Expansion cohort dosing CP-506 in combination with carboplatin in patients at recommended phase 2 dose (RP2D) Intervention: Drug: CP-506
Experimental: Module 3A Combination with Immune Checkpoint Inhibitor Multiple Ascending Dose
Multiple ascending dose cohorts dosing CP-506 in combination with Immune Checkpoint Inhibitor in all patients up to a maximally tolerated or maximally feasible dose Intervention: Drug: CP-506
Experimental: Module 3B Combination with carboplatin Dose Expansion Cohort
Expansion cohort dosing CP-506 in combination with Immune Checkpoint Inhibitor in patients at recommended phase 2 dose (RP2D) Intervention: Drug: CP-506
Sponsors
Leads: Maastricht University Medical Center
Collaborators: Academisch Ziekenhuis Maastricht, Vall d'Hebron Institute of Oncology, Universitair Ziekenhuis Gent, Erasmus Medical Center, Jules Bordet Institute

This content was sourced from clinicaltrials.gov

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