At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Atezolizumab (drug), Futibatinib (drug), Amivantamab (drug)
- How long the study runs
- Study runs about 95 months (dates as stated)
- About the drug or intervention
- Atezolizumab — drug: 1200 mg, administered IV, once every 3 weeks · Futibatinib — drug: 20 mg administered orally, once daily (QD) continuously in 28-day cycles. · Amivantamab — drug: 1050 mg administered IV for body weight \< 80 kg and 1400 mg for body weight \>= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles)
- Patient visit burden
- Not specified by the sponsor
In plain English
This trial is for adults with advanced solid tumours (cancers that have spread or cannot be removed by surgery) that have not responded to standard treatment, or where no standard treatment exists. It has two parts: Part A (iPROFILER) looks at the molecular make-up of your tumour, and Part B (iBASKET) offers treatment matched to those molecular changes. The sponsor is the Vall d'Hebron Institute of Oncology.
Who can take part
- Adults aged 18 or over with an advanced solid tumour that has spread or cannot be removed by surgery, and has not responded to standard treatment, or where standard treatment is not available or suitable
- Being well enough to take part (a performance status score of 0 or 1, meaning you can mostly look after yourself)
- Having tumours that can be measured on scans (RECIST 1.1 is a standard way to measure cancer on scans)
- Having enough tumour tissue available for molecular testing, or being able to have a tumour biopsy (Part A)
- For Part B, your tumour must have specific molecular changes (the study team will check this)
- Good working blood, kidney and liver function; good blood clotting if you need a biopsy
- Being willing to receive treatment matched to your tumour's molecular profile
- For Part B: not pregnant or breastfeeding, and agreeing to use contraception and not donate eggs or sperm during the study and for 6 months after the last dose
Who may not be able to
- Cancer in the membranes around the brain and spinal cord (leptomeningeal disease or carcinomatosis)
- Unstable brain metastases (secondary cancers in the brain that are getting worse or causing symptoms) — treated and stable brain metastases may be allowed under certain conditions
- Spinal cord compression that has not been definitively treated with surgery or radiotherapy (Part A)
- Uncontrolled other illnesses, such as active infection, serious heart problems, or mental health or social situations that would make it hard to follow the study requirements
- Unable to swallow tablets or capsules (Part A)
- Known HIV, hepatitis B or hepatitis C infection (some exceptions for past hepatitis B or C may apply in Part B)
- History of malabsorption (problems absorbing food or medicine) (Part A)
- Part B: any approved anticancer treatment (chemotherapy, hormonal therapy or radiotherapy) within 3 weeks before starting the study treatment (some exceptions apply), or an experimental drug within 3 weeks (or five half-lives, whichever is longer)
- Part B: major surgery or an invasive procedure within 15 days before the first dose
- Part B: significant heart disease, such as a heart attack in the last 3 months, unstable angina or unstable irregular heartbeat
- Part B: another primary cancer within the last 2 years, unless the study doctor considers it low risk of coming back
- Any contraindications listed in the product information of the drugs used in the study
What taking part involves
- • Part A (iPROFILER): your tumour tissue is tested to build a molecular profile of your cancer; you may need to provide stored tissue samples or have a tumour biopsy
- • Part B (iBASKET): if your tumour has certain molecular changes, you may receive a study treatment matched to those changes
Time commitment: Not stated in full — taking part involves providing tumour tissue (possibly a biopsy) for molecular testing and, if matched, receiving study treatment; details of clinic visits and how long the study lasts are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,000
- Started
- 2018-12-10
- Last checked
- 2024-04
Plain English Summary
What is this study?
- • Testing a new treatment for advanced solid tumor
- • Phase2 - 1,000 participants
- • The global objective of this Basket of Basket study is to evaluate the antitumor activity of each matched therapies that will be evaluated through the study in small molecularly selected populations
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with advanced solid tumor
Where?
- • Cambridge - Cancer Research UK Cambridge Centre
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The global objective of this Basket of Basket study is to evaluate the antitumor activity of each matched therapies that will be evaluated through the study in small molecularly selected populations. The objective of module 1 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of atezolizumab in each of the arms of the module. All patients in genomically selected populations will receive atezolizumab 1200 mg IV every 3 weeks. The objective of module 2 wil be to determine the overall response rate (ORR) at 16 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of futibatinib in each of the arms of the module. All patients in genomically selected populations will receive will receive futibatinib, 20 mg, once daily (QD) in 28-day cycles. The objective of module 3 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of amivantamab in each of the arms of the module. All patients in genomically selected populations will receive amivantamab 1050 mg intravenously (IV) for body weight \< 80 kg and 1400 mg for body weight \>= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles).
More detail
Basket studies are a new sort of clinical studies to identify patients with the same kind of mutations and treat them with the same drug, irrespective of their specific cancer type. In basket studies, depending on the mutation types, patients are classified into "baskets". Targeted therapies that block that mutation are then identified and assigned to baskets where patients are treated accordingly. This protocol has two parts: part A (iPROFILER), which includes the common procedures for tumor molecular profiling and treatment recommendation, and part B (iBASKET), which corresponds to the therapeutic portion. The purpose of part A (iPROFILER) of this study is to test participants' tumour tissue in order to identify whether their tumour has certain mutations in cancer-related genes. It is known that gene mutations of tumours contribute to their origin and growth and determine whether the tumour will respond to particular cancer drugs. This test will provide information about potential targeted therapies that specifically attack those gene mutations. The purpose of part B (iBASKET) of this study is to offer participants a personalised anti-cancer treatment based on the gene mutations that are found in their tumour. Participants taking part in module 1 of part B (iBASKET) will receive atezolizumab 1200 mg IV every 3 weeks, following the analysis of their tumour in part A (iPROFILER). Participants will be able to take atezolizumab for as long as their tumour doesn't grow and for as long as they don't have any side-effects which prevent them from continuing treatment. Module 1 will have a 2-year recruitment period. The aim of the study is to determine which genomically selected populations respond effectively to the targeted treatment, atezolizumab. Approximately 1000 participants will be enrolled into part A (iPROFILER), with approximately 120 participants being recruited into module 1 of part B (iBASKET). Participants taking part in module 2 of part B (iBASKET) will receive will receive futibatinib, 20 mg, once daily (QD) in 28-day cycles, following the analysis of their tumour in part A (iPROFILER). Participants will be able to take futibatinib for as long as their tumour doesn't grow and for as long as they don't have any side-effects which prevent them from continuing treatment. Module 2 will have a 2-year recruitment period. The aim of the study is to determine which genomically selected populations respond effectively to the targeted treatment, futibatinib. Approximately 1000 participants will be enrolled into part A (iPROFILER), with approximately 80 participants being recruited into module 2 of part B (iBASKET). Participants taking part in module 3 of part B (iBASKET) will receive amivantamab 1050 mg IV for body weight \< 80 kg and 1400 mg for body weight \>= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles), following the analysis of their tumour in part A (iPROFILER). Participants will be able to take amivantamab for as long as their tumour doesn't grow and for as long as they don't have any side-effects which prevent them from continuing treatment. Module 3 will have a 2.5-year recruitment period. The aim of the study is to determine which genomically selected populations respond effectively to the targeted treatment, amivantamab. Approximately 1725 participants will be enrolled into part A (iPROFILER), with approximately 69 participants being recruited into module 3 of part B (iBASKET).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ ECOG performance status of 0 or 1
- ✓ measurable disease according to RECIST 1
- ✓ enough tumour tissue for molecular analysis
- ✓ disease amenable to be biopsied
What the study is looking for
- ✓Patient must have Fit enough for normal activity (ECOG 0) or 1.
- ✓Subjects must be 18-year-old or older.
- ✓Subjects must have cancer that can be measured on scans according to (standard scan measurements).
- ✓Subjects must have enough tumour tissue for molecular analysis.
- ✓Subjects providing fresh frozen tissue must provide 5 core biopsies or equivalent.
Who cannot take part
- ✗Subjects with leptomeningeal disease should be excluded from this clinical trial.
- ✗Subjects with spinal cord compression not definitively treated with surgery and/or radiation.
- ✗Subjects with inability to swallow tablets or capsules.
- ✗Subjects with known HIV, hepatitis B or hepatitis C infection.
- ✗Subjects with known history of malabsorption.
See the full criteria
Where Is This Study? (1 UK site)
Cancer Research UK Cambridge Centre
Cambridge CB2 0QQ, United Kingdom
How to Get in Touch
Marta Carboneras
Sponsor contactCONTACT
Susana Muñoz
Sponsor contactCONTACT
