Actively Recruiting
Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI
Led by Maastricht University Medical Center · Updated on 2025-10-07
126
Participants Needed
5
Research Sites
204 weeks
Total Duration
On this page
Sponsors
M
Maastricht University Medical Center
Lead Sponsor
E
Erasmus Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Willing and able to provide written informed consent
- Life expectancy of at least 3 months
- Willing to undergo biopsy collection
- ECOG Performance status of 0, 1, or 2
- Adequate organ and bone marrow function including ANC ≥ 1500/µL, hemoglobin ≥ 9.0 g/dL, platelets ≥ 100,000/µL, bilirubin ≤ 1.5 × ULN (or direct bilirubin ≤ ULN if total bilirubin >1.5 × ULN), AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases), creatinine ≤ 1.5 × ULN, and INR ≤ 1.5 × ULN or within therapeutic range if on anticoagulants
- Measurable disease on CT scan according to RECIST 1.1
- If female, not pregnant or breastfeeding and either not of childbearing potential or agrees to contraception and negative pregnancy test before treatment
- If male, agrees to use contraception during treatment and for 4 weeks after last dose
- Able and willing to comply with the protocol
- Module 1: Histologically or cytologically confirmed advanced or metastatic solid tumor with HRD/FAD defects or cancers with increased HRD/FAD incidence or prior response to alkylating agents
- Module 2: Eligible for carboplatin and diagnosed with triple negative breast cancer or ovarian cancer
- Module 3: Receiving immune checkpoint inhibitor monotherapy for at least 6 months with oligoprogressive disease
You will not qualify if you...
- Prior radiotherapy to more than 25% of bone marrow
- Not recovered from acute toxic effects of prior anticancer therapy except mild alopecia or neuropathy
- Significant cardiac conditions (e.g., NYHA Class III/IV heart failure, recent myocardial infarction, unstable angina, serious arrhythmias, pacemaker exceptions)
- Marked prolongation of QT/QTc interval (>450 ms) or risk factors for Torsade de Pointe
- Use of medications that prolong QT/QTc interval
- Uncontrolled infection or infection needing parenteral antibiotics
- Any other significant clinical disorder compromising safety
- Diagnosis or suspicion of rare genetic DNA repair disorders (e.g., Fanconi anemia)
- Concurrent chemotherapy, radiation, hormonal, or biological cancer treatments including immunotherapy
- Investigational drug/device use within 30 days (60 days for biologics)
- Less than 4 weeks since major surgery
- Known HIV, hepatitis B or C with abnormal liver tests
- Allergy to alkylating agents
- CNS metastases except stable asymptomatic with no steroid need for 14 days; leptomeningeal spread excluded
- Recent invasive malignancy except certain treated cancers or stable low-risk prostate cancer
- Autoimmune disease needing systemic treatment within 2 years (replacement endocrinopathy therapy excluded)
- Immunodeficiency or systemic immunosuppressive treatment within 7 days prior to randomization
- Live vaccine within 30 days prior to randomization
- Prior bone marrow or solid organ transplantation
- Current or history of pneumonitis requiring immunosuppressive treatment
- Recent uncontrolled ascites, pleural or pericardial effusions
- Recent gastrointestinal conditions requiring surgery or abscess
- Allergen desensitization therapy within 4 weeks prior to randomization
- Cirrhosis or unstable liver/biliary disease
- Active tuberculosis
- Psychiatric or other conditions interfering with safety or compliance
- Recent anticancer therapy within 4 weeks prior to inclusion, with exceptions based on module and treatment type
- Progressive disease under immune checkpoint inhibitors justifying discontinuation
- Patients not continuing immune checkpoint inhibitors as standard care
- Patients with complete response under immune checkpoint inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Institut Jules Bordet
Brussels, Belgium
Not Yet Recruiting
2
UZ Gent
Ghent, Belgium, 9000
Not Yet Recruiting
3
Academisch Ziekenhuis Maastricht (Leading Centre)
Maastricht, Limburg, Netherlands, 6229HX
Actively Recruiting
4
Erasmus MC
Rotterdam, Netherlands
Actively Recruiting
5
Institut Vall d'Hebron
Barcelona, Spain, 08035
Not Yet Recruiting
Research Team
L
Ludwig Dubois, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here