A Phase II trial of ginisortamab in participants with metastatic pancreatic ductal adenocarcinoma
- Conditions
- Metastatic pancreatic ductal adenocarcinomaCancer
- Registration Number
- ISRCTN63154609
- Lead Sponsor
- Cancer Research UK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 156
Module 1:
1. Written (signed and dated) informed consent, and capable of co-operating with IMP (and SoC) administration and follow-up.
2. Histologically or cytologically confirmed diagnosis of PDAC with metastatic disease.
3. Consent for pre- and on-treatment tumour biopsy samples for assessment of molecular markers, including but not limited to, SMAD4 and gremlin-1. Pre- and on-treatment tumour samples are mandatory in the first instance. These tumour samples may become optional as considered appropriate by the Sponsor and Investigators based on a review of emerging data during the trial. Participants must have disease amenable to biopsy as deemed safe by the Investigator.
4. Measurable disease according to RECIST Version 1.1.
5. Eastern Cooperative Oncology Group performance status of =1.
6. Haematological and biochemical indices within defined ranges. These measurements should be performed to confirm the patient's eligibility to participate in the trial.
7. Aged 18 years or over at the time consent is given.
Module 1 exclusion criteria:
1. Previous radiotherapy (except palliative) within 6 months prior, chemotherapy, investigational therapy for metastatic PDAC, other anti-cancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of IMP.
2. Live vaccinations will not be permitted within 28 days before trial enrolment.
3. Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
4. Prior neo-adjuvant, peri-operative, or adjuvant chemotherapy for non-metastatic pancreatic adenocarcinoma with curative intent unless recurrent (i.e. metastatic) disease is documented more than 6 months since the last dose of systemic therapy.
5. Clinically significant/symptomatic third space fluid accumulation (e.g. ascites or pleural effusion).
6. Ongoing toxic manifestations of previous treatments considered by the Investigator to make the patient unsuitable for the trial.
7. Brain or leptomeningeal metastases.
8. Clinically significant ongoing pulmonary disease, including but not limited to interstitial lung disease, idiopathic pulmonary fibrosis or pulmonary hypersensitivity pneumonitis.
9. History of pulmonary embolism or deep vein thrombosis unless continuing anticoagulant treatment as clinically indicated.
10. Female patients of childbearing potential. However, those patients of childbearing potential who are not already pregnant or breastfeeding, or who agree to discontinue breastfeeding, or who meet the following points are considered eligible:
11. Have a negative highly sensitive serum pregnancy test within 7 days before Day 1 and either:
11.1. Agree to one form of highly effective contraception
11.2. Or agree to sexual abstinence
Effective from the date of the negative pregnancy test, throughout the trial and for 6 months after the last administration of IMP or SoC chemotherapy agents (whichever component is administered last).
11.3. Male patients with partners of childbearing potential or who are pregnant or breastfeeding. However, those patients who meet the following points are considered eligible:
11.3.1. Agree to take measures not to father children by using a barrier method of contraception (condom) or sexual abstinence effective from the date of the first administration of IMP and SoC chemotherapy agents, throughout the trial and for 6 months after the last administration of IMP or SoC chemotherapy agents (whichever component is administered last).
11.3.2. Non-vasectomised male patients must also be willing to ensure that any partner who is of childbearing potential uses a highly effective method of contraception or agrees to sexual abstinence for the same duration.
11.3.3. Male patients with pregnant or breastfeeding partners must be advised to use barrier method contraception (male condom) to prevent exposure of the foetus or neonate.
12. Major thoracic or abdominal surgery from which the patient has not yet recovered.
13. At high medical risk because of non-malignant systemic disease, including active uncontrolled infection.
14. Known hypersensitivity to any of the ingredients/excipients in the IMP to be administered.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method