A trial to assess the safety and efficacy of multiple doses of the CAN04 antibody in combination with different chemotherapy, in patients with advanced solid tumors.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 165

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

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

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

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