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New treatment option for Unspecified Adult Solid Tumor, Protocol Specific
Official title Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI
ClinicalTrials.gov ID: NCT04954599
What this study is testing
What is CP-506?
CP-506 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for unspecified adult solid tumor, protocol specific.
Also referred to as HAP CP-506.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Core:
- Prior radiotherapy to more than 25% of bone marrow
- Not recovered from all acute toxic effects of prior anticancer therapy (excluding CTCAE Grade 1 alopecia or peripheral neuropathy)
- Patients with significant cardiac co-morbidity, such as NYHA Class III or IV CHF, unstable angina, MI within the previous 6 months, or ventricular...
- A marked baseline prolongation of QT/QTc interval (\> 450 ms)
- History of risk factors for Torsade de Pointe (e.g. heart failure, hypokalemia, family history of Long QT syndrome)
See the full eligibility criteria
Who can join
- 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: 6.1. 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...
- Measurable disease on CT scan (RECIST 1.1)
- If female, not pregnant, not breastfeeding, and at least one of the following conditions applies: 8.1. Not a woman of childbearing potential (WOCBP) 8.2. A WOCBP who agrees to follow contraceptive guidance during the...
- 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...
- 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...
What rules you out
- Core:
- Prior radiotherapy to more than 25% of bone marrow
- Not recovered from all acute toxic effects of prior anticancer therapy (excluding CTCAE Grade 1 alopecia or peripheral neuropathy)
- Patients with significant cardiac co-morbidity, such as NYHA Class III or IV CHF, unstable angina, MI within the previous 6 months, or ventricular arrhythmias requiring drug therapy, pacemaker or implanted...
- A marked baseline prolongation of QT/QTc interval (\> 450 ms)
- History of risk factors for Torsade de Pointe (e.g. heart failure, hypokalemia, family history of Long QT syndrome)
- Use of concomitant medication prolonging the QT/QTc interval
- Evidence of uncontrolled infection or infection requiring a concomitant parenteral antibiotic
- Evidence of any other significant clinical disorder or laboratory finding that in the opinion of the Investigator may compromise patient safety during study participation.
- Patients with a diagnosis (or strong suspicion) of a rare genetic disorder related to germline biallelic HR/FA and DNA repair gene mutations, such as Fanconi anemia patients of any subtype, Ataxia telangiectasia...
- Patient or physician plans concomitant chemotherapy, radiation therapy, hormonal and/or biological treatment for cancer including immunotherapy while on study
- Patient has been treated with any investigational drug or investigational therapeutic device within 30 days (60 days in case of biological compound) of initiating study treatment
- Less than 4 weeks since prior major surgery
- Known positive for HIV, Hepatitis B surface antigen positive or Hepatitis C positive with abnormal liver function tests
- Known allergy to alkylating agents
- Central nervous system (CNS) metastases, with the following exception:
- Participants with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to randomization. Note: Participants with carcinomatous meningitis or...
- Invasive malignancy or history of invasive malignancy other than disease under study within the last 3 years, except as noted below: 17.1. Any other invasive malignancy for which the participant was definitively...
- Autoimmune disease (current or history; refer to Table 19) or syndrome that required systemic treatment within the past 2 years Note: Replacement therapies which include physiological doses of corticosteroids for...
- Has a diagnosis of immunodeficiency or is receiving systemic steroids (\>10 mg oral prednisone per day or equivalent) or other immunosuppressive agents within 7 days prior to randomization Note: 19.1. Physiologic doses...
- Receipt of any live vaccine within 30 days prior randomization
- Prior allogeneic/autologous bone marrow or solid organ transplantation
- Has current pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents Note: post-radiation changes in the lung related to prior radiotherapy and/or asymptomatic...
- Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions
- Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intraabdominal abscess
- Recent history of allergen desensitization therapy within 4 weeks of randomization
- Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent...
- Known history of active tuberculosis
- Any psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator Module 1 - monotherapy
- Patients who have received anticancer therapy (including radiotherapy) within 4 weeks of inclusion Module 2 - Carboplatin combination
- Patients who have received anticancer therapy (including radiotherapy) within 4 weeks of inclusion with exclusion of carboplatin. Module 3 - ICI combination
- Patients who have received anticancer therapy (including radiotherapy) within 4 weeks of inclusion with exception of ICI
- Patients progressive under ICI justifying the immediate discontinuation of ICI
- Patients who would not receive further treatment with ICI as standard of care
- Patients with Complete Response under ICI
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Ghent, Belgium
- Maastricht, Limburg, Netherlands
- Rotterdam, Netherlands
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Ghent, Belgium; Maastricht, Limburg, Netherlands; Rotterdam, Netherlands; Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.