A Phase 1/2 trial of GB1275 in patients with Advanced Solid Tumours
Research type
Research Study
Full title
A Phase 1/2, First-in-Human, Open-label, Dose Escalation Study of GB1275 Monotherapy and in Combination with an Anti-PD-1 Antibody in Patients with Specified Advanced Solid Tumors or in Combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma, Followed by Basket Expansion of GB1275 with Standard of Care or in Combination with an Anti-PD-1 Antibody in Patients with Specified Metastatic Solid Tumors
IRAS ID
269257
Contact name
Olivia Richmond
Contact email
Sponsor organisation
GB006, Inc, a wholly owned subsidiary of Gossamer Bio, Inc
Eudract number
2019-001879-37
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
142808, IND
Duration of Study in the UK
6 years, 3 months, 30 days
Research summary
Cancer is the second leading cause of mortality worldwide. Current treatments for cancer such as chemotherapy offer only limited benefit for many individuals with locally advanced or metastatic disease. Thus, effective therapies are needed for patients with advanced solid tumours.
The immune system is the body’s natural defence against disease. The immune system sends types of cells called T cells and natural killer (NK) cells throughout the body to detect and fight infections and diseases including cancers. However, when the cancer is formed, it creates an environment with different cells that prevent the immune system from recognising the cancer.
Gossamer Bio have developed the study drug GB1275 for the treatment of advanced solid tumours. GB1275 is designed to allow immune cells entering the tumour sites to help the immune system to recognise and get rid of the cancer cells.
This research study is divided into two phases: Phase 1 and Phase 2.
The purpose of Phase 1 is to:
• Evaluate the safety and tolerability of the study treatment and to find the highest dose of GB1275 that is tolerable given alone or in combination with pembrolizumab or with nab-paclitaxel and gemcitabine.
• To measure the amount of GB1275, nab-paclitaxel and gemcitabine in the blood at different times and how long the body takes to get rid of the drug.
The purpose of Phase 2 is to:
• Evaluate the safety of the study treatment with the highest tolerable and effective dose of GB1275 determined from Phase 1.
• Evaluate the ability of the study treatment to prevent the cancer from getting worse.
Approximately 82 participants take part in Phase 1 and approximately 120 participants may take part in Phase 2. The study will be conducted in the UK, USA and may also be conducted in additional countries.REC name
London - Central Research Ethics Committee
REC reference
19/LO/1863
Date of REC Opinion
14 Jan 2020
REC opinion
Further Information Favourable Opinion