AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

Study of safety and tolerability of BCA101 monotherapy and in combination therapy in patients with EGFR-driven advanced solid tumors

This clinical trial is studying an experimental medicine called BCA101. It is designed for adults with advanced solid tumours linked to a specific protein called EGFR, which can help cancer cells grow. Because this is a Phase 1 trial, it is the first time BCA101 is being given to people. The main aim of the study is to find out if the drug is safe, what side effects it might cause, and the best dose to give. Researchers will test BCA101 on its own and alongside other cancer therapies. Taking part involves regular hospital visits, health checks, blood tests, and scans. The trial is aimed at people aged 18 and older whose cancer has spread or cannot be removed with surgery. It does not guarantee a cure, but it helps doctors discover whether this new medicine could become a future cancer treatment.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Bicara Therapeutics Inc.

Enrolment target

Start

30 Sep 2026

Advanced solid tumors

What is this study about?

This clinical study is looking at a new experimental medicine called BCA101. It is aimed at people with advanced solid tumours, which are cancers that form firm lumps in body tissues and have grown or spread. In particular, this study focuses on cancers linked to a protein called EGFR. When EGFR is overactive, it can send signals that cause cancer cells to multiply rapidly. BCA101 is designed to target this pathway and help stop the cancer from growing.

Because this is a Phase 1 study, it represents the very first time BCA101 is being tested in humans. In the early stages of drug research, the primary goal is not yet to prove how well the medicine shrinks tumours, but rather to make sure it is safe. Researchers need to learn how the human body handles the drug, what kinds of side effects it may cause, and what dose is safe and well tolerated.

During the trial, doctors will test BCA101 either by itself or combined with other existing cancer medicines. Finding new ways to target EGFR-driven cancers is very important, especially for people whose cancer has stopped responding to standard treatments. By taking part, participants help doctors learn whether BCA101 has the potential to become a useful new option in cancer care.

Key takeaways

This is a Phase 1 trial testing a new cancer medicine, BCA101, in humans for the first time.
The study focuses on adults with advanced solid tumours linked to the EGFR protein.
The main goals are to check safety, identify side effects, and find the right dose.
BCA101 will be given either alone or alongside other cancer drugs.
Taking part requires frequent hospital visits, regular blood tests, and imaging scans.

Who may be eligible?

This trial is open to adults aged 18 and over who have an advanced solid cancer. 'Advanced' usually means the cancer has spread to other parts of the body (secondary or metastatic cancer) or cannot be removed with surgery. The cancer must also be linked to the EGFR protein, which doctors can check by testing a small sample of tumour tissue.

To be eligible, participants usually need to be well enough to carry out daily activities and have adequate liver, kidney, and bone marrow function. The study is generally for people whose cancer has continued to grow despite standard NHS treatments, or for those who do not have other standard treatment options available.

You may not be able to join if you have certain serious medical conditions, such as uncontrolled heart disease or active infections, or if you are pregnant or breastfeeding. The trial team will review your complete medical history and carry out specific tests to confirm whether it is safe for you to take part.

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.

I am aged 18 or older.
I have been diagnosed with an advanced solid cancer.
My cancer is known or suspected to involve the EGFR pathway.
My cancer has grown despite standard treatments, or I have no other standard options.
I am well enough to attend regular hospital appointments for tests and treatment.

Answer every question to see your result.

What does participation involve?

Taking part in this study means you will receive the experimental drug BCA101, either alone or with another cancer treatment, usually given through a drip into a vein (an intravenous infusion) at a specialist hospital clinic. Before you start, the study team will carry out detailed baseline checks, including blood tests, physical examinations, heart traces (ECGs), and imaging scans such as CT or MRI scans.

Because this is a first-in-human trial, you will need to attend the hospital frequently, especially during the first few weeks. These visits allow the medical team to monitor you closely for any side effects and check how the drug is behaving in your body. Scans will be repeated every few weeks or months to see how your tumour is responding.

Your participation will last as long as the treatment is helping you and the side effects are manageable. If your cancer gets worse or you choose to stop, you will enter a follow-up phase where the team checks in on your health periodically.

Potential risks and benefits

Because this is the first time BCA101 is being given to people, there is a risk of unexpected side effects, which could range from mild symptoms like fatigue, sickness, or skin rashes to more serious complications. The study team will monitor you very closely to manage any problems quickly. There is no guarantee that the new drug will shrink your cancer or improve your health, but it may offer another treatment avenue when other options are limited. Taking part also helps researchers develop better treatments for future patients. You are entirely free to leave the trial at any time without giving a reason, and doing so will not affect your normal NHS care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
France

Common questions

What is a Phase 1 clinical trial?

A Phase 1 trial is the earliest stage of testing a new medicine in people. Its main goal is to find out if the drug is safe, what dose works best, and what side effects might happen.

What does 'EGFR-driven' mean?

EGFR is a protein found on the surface of some cells. In certain cancers, there is too much of it or it is faulty, which signals the tumour to grow. EGFR-driven means the cancer relies on this signal.

Will I have to pay for the trial treatment?

No, clinical trial medicines and study-related tests are provided free of charge. Some trials also help cover travel expenses to and from the hospital.

Can I leave the trial if I change my mind?

Yes, you can leave the study at any point. Your decision will never affect the standard of care you receive from your regular doctors.

How is BCA101 given?

BCA101 is typically given as an infusion through a small tube into a vein in your arm at the hospital clinic.