A dose escalation trial to assess the safety and tolerability of multiple doses of the CAN04 antibody, in patients with solid malignant tumors.
- Conditions
- Solid malignant tumors, in the following two indicationsNon-Small Cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC),MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10073364Term: Ductal adenocarcinoma of pancreasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-001111-36-ES
- Lead Sponsor
- Cantargia AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 116
1. Ability to understand and willingness to provide written informed consent before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the subject).
2. Age = 18 year.
3. Measurable disease in accordance to irRC by computed tomography (CT) or magnetic resonance imaging (MRI) scan, no more than 6 weeks prior to screening.
4. At least 4 weeks since the last dose of chemotherapy, radiation therapy, immunotherapy, or surgery; at least 6 weeks for therapy which is known to have delayed toxicity; at least 4 weeks since treatment with biologic/targeted therapies.
5. Eastern Cooperative Oncology Group (ECOG) performance status =1.
6. Adequate bone marrow, hepatic, renal and coagulation function.
7. Clinical laboratory values at screening:
? Serum creatinine <1.5xULN
? Hemoglobin >9.0 g/dL
? Absolute neutrophil count >1000/µL in Part I and >1500/µL in Part II
? Platelets >75x109/L
? Total bilirubin <1.5x ULN
? Aspartate Transaminase (AST) and Alanine Transaminase (ALT) =3x ULN (for subjects with hepatic metastases <5x ULN)
? Prothrombin Time (PT) & Partial Thromboplastin Time (PTT) within 1.5x institutional ULN. In case there are no normal ranges available for the PT test, the international normalized ratio (INR) test may be used instead of PT. At screening, subjects should have an INR <1.5x ULN.
Additional inclusion criterion for Part I
8. Subjects with histologically or cytologically confirmed, unresectable, locally advanced or metastatic NSCLC, PDAC, CRC or TNBC tumor, relapsed or refractory to standard therapy or for which there is no standard therapy.
Additional inclusion criterion for Part II:
9. Arm A, Arm B and Arm E: Subjects with histologically or cytologically confirmed, unresectable, locally advanced or metastatic squamous or non-squamous NSCLC or PDAC, relapsed or refractory to standard of care therapy or for whom there is no standard therapy.
10. All arms: Presence of tumor lesions amenable to biopsy and willingness to undergo repeat biopsies of these tumor lesions.
11. Arm C only:
11a: Subjects with histologically or cytologically confirmed diagnosis of unresectable stage IIIB or stage IV squamous or non-squamous NSCLC
11b: Subjects must be eligible to receive a first line standard chemotherapy regimen with cisplatin/gemcitabine or a second line standard chemotherapy regimen with cisplatin/gemcitabine after relapsing from first line with pembrolizumab monotherapy.
11c: Subjects who underwent (neo)adjuvant treatments are eligible if the (neo)adjuvant treatment ended at least 6 months prior to inclusion.
12. Arm D only:
12a: Subjects with newly diagnosed, treatment na?ve, histologically or cytologically confirmed, unresectable, locally advanced or metastatic (stage III or stage IV) PDAC.
12b: Subjects must be eligible to receive treatment with nabpaclitaxel and gemcitabine.
12c: Subjects who underwent (neo)adjuvant treatments are eligible if the (neo)adjuvant treatment ended at least 6 months prior to inclusion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
1. Known or suspected allergy to trial product or related product.
2. Subjects receiving live vaccination, etanercept or other TNF-a inhibitors
or any other investigational agents during or just prior to (within 28 days
of first study drug administration) participation in this study.
3. Previous participation in this trial (enrolled).
4. Clinical evidence of an active second malignancy.
5. Subjects with a life expectancy <12 weeks.
6. Uncontrolled or significant cardiovascular disease defined as New York Heart Association Classification III, or IV.
7. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
8. Not recovered from the adverse effects of prior therapy at the time of enrollment to = grade 1, with the exception of alopecia grade 2.
9. Symptomatic brain metastases, which are either untreated or uncontrolled by surgery and/or radiotherapy.
10. Immunocompromised subject currently receiving systemic therapy.
11. Subjects with history of HIV, hepatitis B or C exposure currently controlled by antiviral therapy.
12. Known bleeding disorder or coagulopathy.
13. Subjects with microbial or viral infection, which is not controlled by appropriate medication. Subjects with any type of chronic infection.
14. Women who are pregnant or breastfeeding.
15. Women of childbearing potential (WOCBP, defined as < 2 years after last menstruation and not surgically sterile) or men whose sexual partners are WOCBP who are unwilling or unable to use a highly effective method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3-6 months after the last dose of study medication, depending on the treatment arm. Also see section 6.1.10.1 – Contraception Methods
16. Evidence of serious uncontrolled medical disorder or active infection that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol.
17. Other medical conditions that in the opinion of the investigator disqualify the subject for inclusion.
18. Only for Arm C:
18a Prior lines of treatment with anti-cancer medication other than pembrolizumab monotherapy administered as 1st line.
18b Known tumor EGFR mutation, unless contraindication to EGFRdirected therapy.
18c Known tumor ALK rearrangements, unless contraindication to ALKdirected therapy or ALK-directed therapy not available.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method