Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors
This research study is investigating two experimental medicines, Livmoniplimab and Budigalimab, for adults with advanced solid tumours (cancers that start in organs or soft tissues). The main goals are to understand how safe the drugs are, how well your body handles them, and to find the best dose to use in future studies. Researchers also want to see if these drugs can help shrink or control cancer, either when given alone or in combination. The study is divided into two main parts: an initial dose-finding stage and a later stage to expand on those findings. This is a Phase 1 study, meaning it’s one of the first times these drugs are being tested in people.
At a glance
What is this study about?
This study is a clinical trial, which means it's a way for doctors and scientists to test new treatments for diseases like cancer. This particular study is looking into two new medicines, Livmoniplimab and Budigalimab, for people who have advanced solid tumours. A 'solid tumour' is a type of cancer that forms a lump, like breast cancer, lung cancer, or bowel cancer, rather than a blood cancer like leukaemia. 'Advanced' means the cancer has grown or spread.
The main purpose of this study is to gather important information about these new drugs. Researchers want to find out if they are safe to use, how well people tolerate them (meaning, how many side effects they experience), and how the body processes these medicines. A very important part of this study is finding the 'recommended Phase 2 dose.' This means finding the right amount of the medicine that can be given safely and might be effective, which will then be used in larger studies.
Ultimately, the hope is that these new drugs, either by themselves or when used together, could offer a new treatment option for people whose cancers have not responded to existing therapies or for whom standard treatments are not suitable. This is an early-stage study (Phase 1), which means it's about learning the basics of how the drugs work in people, rather than proving they are a cure. The study is split into two parts: a 'dose escalation' part to carefully increase the dose until the best one is found, and then a 'dose expansion' part where more people receive that chosen dose.
Key takeaways
- This is an early-stage study (Phase 1) of new cancer drugs.
- It's for adults with advanced solid tumours that haven't responded to other treatments.
- The main goals are to find a safe dose and understand how the drugs work.
- You will receive one or both of the new drugs, Livmoniplimab and Budigalimab.
- Close monitoring for side effects is a key part of the study.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you must be an adult aged 18 or over. For the initial part of the study (called 'dose escalation'), you need to have an advanced solid tumour that hasn't responded to, or you can't tolerate, standard cancer treatments. This also includes people who have refused standard treatments or can't have them, after a discussion with the study team.
For the later part of the study (called 'dose expansion'), specific types of cancer are being looked at more closely. For example, if you have advanced pancreatic cancer, your cancer must have progressed after at least one previous course of chemotherapy. If you have a type of bladder or urinary tract cancer (urothelial cancer), your cancer must have progressed after certain treatments, including specific types of chemotherapy and immunotherapy.
Importantly, there are general health criteria and specific details about your cancer type that will be carefully checked by the study doctors to make sure this study is safe and appropriate for you. Your medical history, current health, and specific cancer progression will all be considered.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have an advanced solid tumour?
- Has your cancer progressed despite standard treatments, or are you unable to receive them?
- Do you meet the specific criteria for pancreatic cancer or urothelial cancer if applicable?
- Are you generally well enough to participate in a clinical trial?
What does participation involve?
If you join this study, you will have regular visits to the clinic. At these visits, you'll have various tests and assessments, which might include blood tests, urine tests, body scans (like CT scans or MRI scans) to check your cancer, and physical examinations. You will receive either Livmoniplimab, Budigalimab, or both, depending on which part of the study you are in. The study team will explain how and when these medications are given. Your health will be closely monitored for any side effects. The total length of your participation will depend on how you respond to the treatment and the stage of the study you're in, but you will undergo regular follow-up appointments and checks while on the study and for a period afterwards.
Potential risks and benefits
Locations (64)
- Highlands Oncology Group, PA /ID# 218942Verified postcodeSpringdale, United States
- City of Hope National Medical Center /ID# 265620Verified postcodeDuarte, United States
- City of Hope Orange County Lennar Foundation Cancer Center /ID# 270785Verified postcodeIrvine, United States
- Yale University School of Medicine /ID# 208356Verified postcodeNew Haven, United States
- AdventHealth Celebration /ID# 224860Verified postcodeCelebration, United States
- Duplicate_AdventHealth Cancer Institute - Orlando /ID# 226953Verified postcodeOrlando, United States
- Indiana Univ School Medicine /ID# 208384Verified postcodeIndianapolis, United States
- Community Health Network, Inc. /ID# 257032Verified postcodeIndianapolis, United States
- Univ Michigan Med Ctr /ID# 221129Verified postcodeAnn Arbor, United States
- Washington University-School of Medicine /ID# 259684Verified postcodeSt Louis, United States
- Intermountain Health West End Clinic Gynecologic Oncology /ID# 266171Verified postcodeBillings, United States
- NYU Langone Medical Center /ID# 209822Verified postcodeNew York, United States
Common questions
What does 'Phase 1' mean for a clinical trial?
Phase 1 trials are the first step where new drugs are tested in people. The main goal is to check safety, find the best dose, and see how the body handles the medicine, rather than focusing on how well it treats the disease.
What are 'solid tumours'?
Solid tumours are cancers that form a mass or lump, like cancers of the lung, breast, or colon, as opposed to blood cancers like leukaemia.
Will I definitely receive one of the new drugs?
Yes, everyone participating in this study will receive either Livmoniplimab alone, or Livmoniplimab combined with Budigalimab. There is no placebo group.
What happens after the study ends?
After you stop taking the study drugs, the research team will continue to monitor your health for a period. If the drugs show promise, they might move into larger studies (Phase 2 and 3).
What does 'refractory' mean regarding my cancer?
If your cancer is 'refractory' to treatment, it means it has not responded well to, or has stopped responding to, treatments that are usually given for your type of cancer.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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