ISRCTN26628699
Active, not recruiting
Phase 1
A Cancer Research UK Phase I/II trial to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of UCB4594 alone and in combination with anti-cancer treatments in participants with advanced malignancies
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced solid tumours
- Sponsor
- Cancer Research UK
- Enrollment
- 167
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written (signed and dated) informed consent and capable of co\-operating with IMP administration and follow\-up.
- •2\. Participant population: Histologically or cytologically proven advanced solid tumours (as specified below), refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the participant. Module A (dose escalation): Tumour types which have shown high levels of human leucocyte antigen (HLA)\-G expression (as reported in the literature): head and neck squamous cell carcinoma, non\-small cell lung cancer, colorectal cancer, triple\-negative breast cancer, renal cell cancer (clear cell only), oesophago\-gastric cancer (excluding gastrointestinal stromal tumour), cervical cancer, ovarian cancer, pancreatic cancer. N.B. Participants with small cell type cancers on histology/cytology are excluded. Pre\-treatment biopsies are mandatory for all participants. Paired biopsies will be mandatory for participants from doses of 30 mg and higher. Participants must have disease amenable to biopsy (excluding bone metastases) as deemed safe by the Investigator.
- •3\. Measurable disease, according to RECIST v1\.1
- •4\. Life expectancy of at least 12 weeks
- •5\. Eastern Cooperative Oncology Group performance status of 0 or 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. Participants aged 16–17 years may be eligible for recruitment to the backfill cohorts in dose escalation once adequate safety and toxicity data have been established in participants aged 18 years or over. All relevant data will be reviewed and a decision on the inclusion of participants aged 16–17 years will be made by the Trial Management Group.
Exclusion Criteria
- •1\. Radiotherapy (except palliative), endocrine therapy (unless for non\-malignant disease), chemotherapy, targeted therapy or immunotherapy, or any other investigational medicinal products (IMPs) during the previous 4 weeks or 5 half\-lives (whichever is shorter) before the first dose of IMP
- •2\. Ongoing toxicity of previous treatments \>CTCAE Grade 1 (except alopecia of any grade, stable Grade 2 peripheral neuropathy or hormone\-replacement therapy (HRT)\-managed endocrine disorders)
- •3\. Patients with rapidly progressing / symptomatically deteriorating brain/leptomeningeal metastases/untreated brain metastases are excluded. Patients with previously treated brain metastases are eligible if they haven't had a seizure or a clinically significant change in neurological status or required steroids in the last 2 weeks
- •4\. Pregnant or breastfeeding female patients (or planning to breastfeed)
- •5\. Women of childbearing potential. However, those not already pregnant or breastfeeding (or discontinue breastfeeding) and meet the following are eligible:
- •5\.1\. Have a negative serum pregnancy test within 7 days before enrolment and either:
- •5\.2\.1\. Agree to a form of highly effective contraception plus a barrier method, or
- •5\.2\.2\. Agree to sexual abstinence
- •Effective from the negative pregnancy test, throughout the trial and for 10 months after the last dose of UCB4594\.
- •6\. Male patients with partners of childbearing potential. However, patients who meet the following are eligible:
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 1
A Phase I/IIa trial of BT1718 in patients with advanced solid tumours.ISRCTN11160449Cancer Research UK66
Active, not recruiting
Phase 1
An early trial of a new type of three-dimensional imaging called [124I]mIBG PET/CT in children with a type of cancer called neuroblastoma.EUCTR2012-002029-31-GBCancer Research UK33
Active, not recruiting
Phase 1
A Cancer Research UK randomised phase II trial of ATN-224 (copper binding agent) in combination with exemestane versus exemestane alone in post-menopausal women with recurrent or advanced, oestrogen and/or progesterone receptor positive breast cancerrecurrent or advanced oestrogen and/or progesterone receptor positive breast cancerMedDRA version: 9.1 Level: LLT Classification code 10006198 Term: Breast cancer recurrentEUCTR2007-005752-16-GBCancer Research UK111
Active, not recruiting
Phase 1
A Cancer Research UK randomised phase II trial of ATN-224 (copper binding agent) in combination with letrozole versus letrozole alone in post-menopausal women with recurrent, oestrogen and/or progesterone receptor positive breast cancerrecurrent oestrogen and/or progesterone receptor positive breast cancerMedDRA version: 14.0Level: PTClassification code 10006198Term: Breast cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2006-004149-40-GBCancer Research UK111
Active, not recruiting
Phase 2
A Phase II trial of ginisortamab in participants with metastatic pancreatic ductal adenocarcinomaMetastatic pancreatic ductal adenocarcinomaCancerISRCTN63154609Cancer Research UK156