advanced tumours Metastatic tumours
Conditions
Interventions
Infusion of CD307
Sponsors
Crescendo Biologics Limited
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Capable of understanding the written informed consent, provides signed and witnessed written informed consent and agrees to comply with protocol requirements. 2. Aged at least 18 years at the time of signing informed consent. 3. Has documented histologically confirmed diagnosis of advanced or metastatic solid tumours. 4.Meets at least one of the following PSMA-based eligibility criteria: For patients with non-prostate cancer: At least one of the following: a. PSMA positivity by IHC in an FFPE sample obtained prior to the initiation of study enrolment (defined as availability of a representative archived pre-treatment tumour specimen for submission to central reader). Brushing, cell pellet from ascites or pleural effusion or lavage samples are not acceptable. Samples of bone lesion or samples that require a decalcification procedure are acceptable. b. PSMA positivity by IHC in a fresh tumour biopsy sample set in formalin including decalcification of bone metastases (brushing, cell pellet from pleural effusion or lavage samples are not acceptable) obtained prior to initiation of study treatment for submission to central reader. -Provision of fresh tumour samples is a preferable option even if FFPE is available and site can submit both FFPE and fresh samples. For patients with prostate cancer: At least one of the following: a.Documented PSMA+ lesion determined by local PSMA-PET scan obtained between the last anti-cancer treatment and prior to commencing CB307 study treatment. -Note that while a positive PSMA test result by IHC is not required for eligibility if PSMAPET positive status is confirmed locally, provision of a fresh tissue sample or archival tumour sample is still requested form retrospective PSMA-IHC analysis on-study. b.PSMA positivity by IHC in an FFPE newly obtained biopsy or archival sample prior to the initiation of study enrolment. Brushing, cell pellet from ascites or pleural effusion or lavage samples are not acceptable. Samples of bone lesion or samples that require a decalcification procedure are acceptable. -Provision of fresh tumour samples is a preferable option even if FFPE is available; sites may submit both FFPE and fresh samples. 5. Has an Eastern Cooperative Oncology Group Performance Status 0 or1. 6. Has adequate organ function. For further information, please refer to the clinical protocol.
Exclusion criteria
Exclusion criteria: - Has evidence of autoimmune or significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results. - Has discontinued from anti-cytotoxic lymphocyte-associated protein 4, anti-PD1 or anti-PD-L1 antibody because of intolerable toxicity according to the investigator*s assessment. - Has brain metastasis including leptomeningeal metastasis or primary brain tumour. - Has encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent. - Has current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis or a neurodegenerative disease. - Has uncontrolled pleural effusion, pericardial effusion or ascites that require regular recurrent drainage procedures. - Is currently receiving bisphosphonate therapy for symptomatic hypercalcaemia. - Has active second malignancy. -Has significant cardiovascular/cerebrovascular vascular disease within 6 months prior to the first dose of CB307, including any of the following: hypertensive crisis/encephalopathy, uncontrolled hypertension (systolic >150 mm Hg and/or diastolic >100 mm Hg), unstable angina, transient ischaemic attack/stroke, congestive heart failure (NYHA III or greater), serious cardiac arrhythmia requiring treatment (exceptions are atrial fibrillation, paroxysmal supraventricular tachycardia), history of thromboembolic events (such as myocardial infarction, stroke or pulmonary embolism). - Has known HIV-1, HBV or HCV infection. - Has known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalisation (relating to the completion of the course of antibiotics, except if for tumour fever) within 28 days prior to the first dose of CB307. - Has a history of chronic liver disease or evidence of hepatic cirrhosis. - Has any other diseases, metabolic dysfunction, physical examination finding or clinical laboratory finding that give reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications, in the opinion of the investigator. - Has had major surgery or significant traumatic injury within 28 days prior to the first dose of CB307 (excluding biopsies) or anticipation of the need for major surgery during study treatment or 3 months after the last dose. - Administered a live attenuated vaccine within 28 days prior to the first dose of CB307 or anticipation that such a live attenuated vaccine will be required during the study or 3 months after the last dose. - Has dementia or altered mental status that would prohibit informed consent. - Has a known hypersensitivity to any of the components of CB307 or history of severe hypersensitivity reactions to antibodies (NCI CTCAE v5.0 grade >=3). - Adverse events (grade 1 or baseline) not recovered from previous anticancer treatment. - Last dose with any of the following agents: etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept, efalizumab or similar systemic immune modulator within 28 days or 5 half-lives, whichever is longer, prior to t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The nature and frequency of any DLTs during the DLT-monitoring period assessed based on NCI CTCAE v5.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tumour response based on the RECIST v1.1 2. Tumour response and PSA response according to PCWG3 3. Serum CB307 PK parameters 4. Overall Survival 5. Change from baseline in anti-CB307 antibodies (ADA). | — |
Countries
Netherlands
Outcome results
None listed