A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors
- Conditions
- Non Small Cell Lung CancerPancreatic Ductal AdenocarcinomaTriple Negative Breast CancerColorectal Cancer
- Registration Number
- NCT03267316
- Lead Sponsor
- Cantargia AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 167
Inclusion Criteria:<br><br> 1. Age = 18 year.<br><br> 2. Measurable disease in accordance to iRECIST by computed tomography (CT) or magnetic<br> resonance imaging (MRI) scan, no more than 6 weeks prior to screening.<br><br> 3. At least 4 weeks since the last dose of radiation therapy, immunotherapy, or<br> surgery; at least 6 weeks for therapy which is known to have delayed toxicity; at<br> least 4 weeks since treatment with biologic/targeted therapies.<br><br> 4. Eastern Cooperative Oncology Group (ECOG) performance status =1.<br><br> 5. Histologically or cytologically confirmed diagnosis of unresectable stage III or<br> stage IV squamous or non-squamous NSCLC (applicable Part II, Combination - NSCLC<br> (NCG) arm only).<br><br> - Subjects must be eligible to receive first line standard chemotherapy regimen<br> with cisplatin/gemcitabine or a second line standard chemotherapy regimen with<br> cisplatin/gemcitabine after relapsing from first line with pembrolizumab<br> monotherapy.<br><br> - Subjects with actionable mutations (EGFR, ALK, ROS) can be enrolled if they<br> have previously progressed to all approved standard of care targeted therapies<br> and the next line of standard therapy is a platinum doublet.<br><br> 6. Histologically or cytologically confirmed diagnosis of unresectable stage III or<br> stage IV non-squamous NSCLC (applicable Part II, Combination - non-squamous NSCLC<br> NCP arm only).<br><br> - Subjects must be eligible to receive first line standard chemotherapy regimen<br> with carboplatin/pemetrexed or a second line standard chemotherapy regimen with<br> carboplatin/pemetrexed after relapsing from first line with pembrolizumab<br> monotherapy.<br><br> - Subjects with actionable mutations (EGFR, ALK, ROS) can be enrolled if they<br> have previously progressed to all approved standard of care targeted therapies<br> and the next line of standard therapy is a platinum doublet.<br><br> 7. Newly diagnosed, treatment na?ve, histologically confirmed, unresectable, locally<br> advanced or metastatic (stage III or stage IV) PDAC (applicable Part II, Combination<br> - PDAC arms only).<br><br> - Subjects must be eligible to receive treatment with nab-paclitaxel and<br> gemcitabine.<br><br>Exclusion Criteria:<br><br> 1. Subjects receiving live vaccination, etanercept or other TNF-a inhibitors or any<br> other investigational agents during or just prior to (within 28 days of first study<br> drug administration) participation in this study.<br><br> 2. Clinical evidence of an active metastatic second malignancy.<br><br> 3. Subjects with a life expectancy <12 weeks.<br><br> 4. Uncontrolled or significant cardiovascular disease defined as New York Heart<br> Association Classification III, or IV.<br><br> 5. Immunocompromised subject currently receiving systemic therapy.<br><br> 6. Other medical conditions that in the opinion of the investigator disqualify the<br> subject for inclusion.<br><br> 7. Applicable Part II, Combination - NSCLC (NCG and NCP) arms only<br><br> - Prior lines of treatment with anti-cancer medication other than pembrolizumab<br> administered as 1st line.<br><br> - Known tumor EGFR mutation, unless contraindication to EGFR-directed therapy or<br> if the subject has progressed to all approved anti-EGFR therapies.<br><br> - Known tumor ALK rearrangements, unless contraindication to ALK-directed therapy<br> or ALK-directed therapy not available or if the subject has progressed to all<br> approved anti-EGFR therapies.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
- Secondary Outcome Measures
Name Time Method Maximum concentration (Cmax);Terminal half-life (t1/2);Clearance (CL);Apparent volume of distribution during the terminal phase (VZ);Area under the curve from time 0 to infinity (AUC0-8);Anti-drug antibodies (ADA) against CAN04;Preliminary signs of efficacy as assessed by tumor response