Advanced solid tumors MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Or
Conditions
Sponsors
Cantargia AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General: 1. Subjects >= 18 years of age 2. ECOG 0-1 Phase I: 1. Subject has histologically or cytologically confirmed diagnosis of locally advanced cancer or metastatic cancer. 2. Subject has a condition where all standard therapeutic options with proven survival benefit have been exhausted, refused by the subject, or are contraindicated. OR Subject has a condition where 1 of the 3 study regimens (mFOLFOX, DTX, or G/C) is considered SoC for the next-line treatment. Phase II: 1. Subject must have at least 1 measurable lesion as defined by RECIST v1.1. 2. Subjects with histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of rectum or colon, squamous or non-squamous unresectable stage IIIB or stage IV NSCLC, or non-resectable, recurrent, or metastatic biliay tract cancer amenable for G/C treatment For a complete list of inclusion criteria, please refer to Protocol, section 4.1.1 Inclusion Criteria 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 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: General Study Exclusion Criteria: 1. Subject has a known or suspected allergy to study drugs (including chemotherapy regimens), any of its components. 2. Subject has another histologically confirmed cancer different from those described in inclusion criteria, except for cervical carcinoma in situ, superficial non-invasive bladder tumour, curatively treated stage I non-melanoma skin cancer, or prostate cancer subjects curatively treated with surgery or radiation and not receiving systemic or androgen deprivation therapy. 3. Subject has uncontrolled or significant heart failure defined as New York Heart Association Classification III or IV. 4. Subjects to receive mFOLFOX or DTX: having peripheral sensory neuropathy Grade =2. 5. Subject has QT interval corrected using Fridericia’s formula (QTcF) >480 msec at screening. 6. Subjects to receive DTX and CAN04: if they have liver metastases and aspartate aminotransferase (AST) and/or ALT >1.5 × upper limit of normal (ULN) concomitant with alkaline phosphatase >2.5 × ULN. 7. Subject has uncontrolled brain metastases. Subjects are allowed to be enrolled if brain metastasis has been previously treated with surgery, and/or stereotactic radiosurgery and are considered controlled (controlled by the dose =10 mg/day of prednisone or equivalent) at the time of the first dose of CAN04. For asymptomatic subjects, brain imaging during screening is not required. 8. Subject has an active severe infection requiring parenteral antibiotics at the time of enrolment or subjects currently receiving oral antibiotics as a continuation of a previous course of parenteral antibiotics. Subjects can be enrolled when antibiotic treatment is complete and if there are no signs of residual infection. 9. Subject has a history of autoimmune disease requiring systemic immunosuppressive therapy (daily prednisone equivalent doses >10 mg/day). 10. Subject is expected to require any other form of systemic or localised anti-neoplastic therapy while on study (including maintenance therapy with another agent, radiation therapy, and/or surgical resection). 11. Subject has had an allogeneic tissue/solid organ transplant. For a complete list of exclusion criteria, including Dose Escalation Phase (Phase 1) and Phase 2 please refer to Protocol, section 4.1.2 Study Exclusion Criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Phase 1 • Nature, grade, and frequency of DLTs • Frequency, duration, and severity (according to CTCAE v5.0) of AEs • Changes in vital signs, serum chemistry, and haematology • Treatment modifications measured as a percentage of relative dose intensity • Percentage of subjects discontinued from all or part of study treatment and reasons for discontinuations Phase 2 ORR defined as the percentage of subjects with PR or CR based on RECIST v1.1 ;Timepoint(s) of evaluation of this end point: Throughout the study;Main Objective: Phase 1: To assess the safety and tolerability of CAN04 in combination with selected standard chemotherapy regimens and to establish MTD and/or RP2D. Phase 2: To assess the preliminary efficacy of CAN04 in combination with chemotherapy regimens measured as tumour response. ;Secondary Objective: Phase 1 Efficacy: To assess preliminary anti-tumour activity of CAN04 in combination with selected standard chemotherapy regimens. PK: To characterize the PK profiles of CAN04 after a single dose and at steady state after multiple doses in combination with chemotherapy using a population PK analysis approach. Phase 2 Safety: To further characterise the safety and tolerability of CAN04 in combination with chemotherapy at the MTD/RP2D. Efficacy: To assess the preliminary efficacy of CAN04 in combination with chemotherapy regimens measured as additional tumour response, time-to-event endpoints, and change in serum biomarkers. PK: To characterise the PK profiles of CAN04 after a single dose and at steady state after multiple doses in combination with chemotherapy using a population PK analysis approach. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase 1 Efficacy: • ORR defined as the percentage of subjects with PR or CR based on RECIST v1.1 • iORR defined as the percentage of subjects with iPR or iCR based on iRECIST • PFS per RECIST v1.1, measured from the start of study treatment until disease progression or death from any cause • iPFS by iRECIST • DCR measured as a percentage of subjects with CR + PR + SD =16 weeks • iDCR measured as a percentage of subjects with iCR + iPR + iUPD/iSD =16 weeks • DOR defined as the time from response to progression/death • Change from baseline upon treatment in serum biomarkers: CEA and CA19-9 (CEA for subjects with CRC; CEA and CA19-9 for subjects with BTC) • Changes from baseline upon treatment in ECOG PS and body weight PK: • Serum PK parameters of CAN04 and potential covariates that impact the PK parameters Phase 2 Safety: • Frequency, duration, and severity (according to CTCAE v5.0) of AEs • Changes in vital signs, serum chemistry, and haematology • Treatment modifications measured as a percentage of relative dose intensity • Percentage of subjects discontinued from all or part of study treatment and respective reason for discontinuation Efficacy: • iORR defined as the percentage of subjects with iPR or iCR based on iRECIST • PFS per RECIST v1.1, measured from the start of study treatment until disease progression or death from any cause • iPFS per iRECIST • OS measured from the start of treatment until death from any cause • DCR measured as a percentage of subjects with CR + PR + SD =16 weeks • iDCR measured as a percentage of subjects with iCR + iPR + iUPD/iSD =16weeks • DOR defined as the time from response to progression or death • Change from baseline upon treatment in serum biomarkers: CEA and CA19-9 (CEA for subjects with CRC. CEA and CA19-9 for subjects with BTC) • Changes from baseline upon treatment in ECOG PS and body weight PK: • Serum PK parameters of CAN04 and potential co | — |
Countries
Belgium, France, Israel, Latvia, Lithuania, Poland, Spain, United Kingdom
Contacts
Public ContactProject Management
PPD
Outcome results
None listed