Phase 1 Study of ADCT-901 in Patients with Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Antitumor Activity

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What is this study about?

The study focuses on patients with Advanced Solid Tumors, which are cancers that have spread beyond their original location and cannot be removed by surgery. The investigational drug being tested is called ADCT-901, given by an intravenous (IV) infusion, meaning it is delivered directly into a vein through a small needle.

The purpose of the study is to find a safe and effective dose of the medication for future testing. This phase 1 trial first uses a dose-escalation approach, where small groups of participants receive gradually higher amounts of the drug while doctors watch closely for any serious side effects. Once a suitable dose is identified, a dose-expansion part enrolls more participants to further assess safety and how the drug works in the body (pharmacokinetics) and against the cancer (antitumor activity). Participants attend regular visits for physical exams, blood tests, heart checks (12‑lead ECG), and imaging scans, and the study records any side effects, especially those that stop dose increases (dose limiting toxicities).

Throughout the trial, doctors also look at how the tumors respond using a standard measurement system called RECIST, which compares the size of tumors on scans before and after treatment. They track how long the tumor stays controlled, overall survival, and the patient’s ability to carry out daily activities using a simple scale (ECOG). Information gathered will help determine whether the drug shows promise for further development.

1 enrollment and consent

after you are screened and meet the study criteria, you sign a consent form that explains the trial.

the study team records your basic information and confirms that you understand the procedures.

2 baseline assessments

you undergo a physical exam, blood tests, and vital‑sign measurements.

your performance status is evaluated using a simple scale that describes how well you can carry out daily activities.

an electrocardiogram (ecg) is performed to check heart rhythm.

imaging scans are taken to document the size and location of your tumors.

3 first dose administration

you receive adct-901 as an intravenous infusion. the dose is 22 mg, prepared from a powder that is mixed into a solution for infusion.

the infusion is given through a needle placed in a vein and takes place in a clinical setting.

4 post‑infusion monitoring

after the infusion you are observed for a period of time while nurses check your vital signs and look for any immediate side effects.

blood samples may be taken to measure how the drug is processed in your body.

5 subsequent dosing cycles

additional infusions of adct-901 are given in repeated cycles according to the study schedule.

each cycle repeats the same dose of 22 mg unless the study team decides to adjust it based on your safety data.

6 dose escalation (early part of study)

in the dose‑escalation phase, some participants may receive a higher dose to find the maximum amount that can be tolerated.

the decision to increase the dose is based on the frequency and severity of side effects observed in earlier participants.

7 regular safety assessments

at each visit you have blood tests, vital‑sign checks, performance‑status evaluations, and ecg recordings.

the study team records any adverse events (unwanted side effects) and grades their seriousness.

8 tumor response evaluation

periodic imaging scans are performed to see whether the tumors are shrinking, staying the same, or growing.

the results help determine the overall response rate of the treatment.

9 dose modifications

if you experience significant side effects, the study team may temporarily pause the treatment, reduce the dose, or adjust the schedule.

these changes are made to keep you as safe as possible while continuing the study.

10 treatment discontinuation

treatment stops after a predefined number of cycles, if the disease progresses, or if side effects become unacceptable.

the decision is documented and you are informed of the reason.

11 follow‑up visits

after treatment ends, you continue to attend follow‑up visits for safety monitoring and tumor assessment.

these visits may include blood tests, vital‑sign checks, ecg recordings, and imaging scans for a period defined by the study protocol.

Who Can Join the Study?

Written informed consent must be signed before any study procedures are done.
You must be 18 years of age or older, and can be male or female.
You must have a diagnosis of a selected solid tumor that is locally advanced or has spread (metastatic). The cancers that are allowed include cholangiocarcinoma, ovarian or fallopian tube cancer, prostate cancer (including certain variants), renal cell carcinoma, and triple‑negative breast cancer.
Your disease must be refractory to, or you must be unable to tolerate, existing treatments that are normally helpful, as judged by your doctor.
You need to have measurable disease that can be evaluated with imaging tests (CT or MRI). This includes tumors that can be measured according to RECIST v1.1 guidelines. For prostate cancer, if no measurable tumor is seen, bone metastases with a PSA level of at least 2.0 ng/mL are acceptable.
You must provide a tumor tissue sample. For the first two dose levels, an existing preserved tissue block (FFPE) is required. For later dose levels, a fresh biopsy or a recent preserved block is needed, and you must agree to undergo another biopsy after receiving at least one dose of the study drug.
Your ECOG performance status must be 0, 1, or 2, meaning you are fully active (0) or able to care for yourself and get out of bed more than half the day (1‑2).
Your doctor must judge that you have a life expectancy of at least 3 months.
You must have adequate organ function, shown by recent lab tests:
- White blood cell count (absolute neutrophil count) ≥ 1,500 per microliter, without growth‑factor support for at least 72 hours.
- Platelet count ≥ 100,000 per microliter, with no platelet transfusion in the past 10 days.
- Hemoglobin ≥ 9 g/dL (about 5.6 mmol/L); a transfusion is allowed if it was given at least 7 days before the first study dose.
- Liver enzymes (ALT and AST) ≤ 2.5 times the normal limit if the liver is not involved, or ≤ 5 times if the liver is involved.
- Total bilirubin ≤ 1.5 times the normal limit (up to 3 times if you have Gilbert’s syndrome, with direct bilirubin ≤ 1.5 times normal).
- Kidney function measured as creatinine clearance ≥ 45 mL/min.
You must be willing and able to keep good oral hygiene throughout the treatment period.
If you are a woman who could become pregnant, you must use a highly effective birth control method from the time you sign the consent until at least 10 months after your last study dose. If you are a man with a partner who could become pregnant, you must use a condom every time you have sex or abstain from sex from the time you sign the consent until at least 7 months after your last study dose.

Who Cannot Join the Study?

Participating in another experimental study at the same time (you can join after that study is finished).
Having a severe allergic reaction (Grade 3 or higher) to any therapeutic antibody (a type of medication made from antibodies).
Having received a solid organ transplant (such as a kidney or liver) in the past.
Being HIV positive with any of the following: a low CD4+ T‑cell count (< 350 cells/μL, a measure of immune health), a serious infection related to AIDS in the past year, not being on HIV medicine or on it for less than six weeks, or a high amount of virus in the blood (viral load ≥ 400 copies/mL).
Having chronic hepatitis B infection and not willing or able to take standard antiviral medicine, or having a detectable amount of hepatitis B virus in the blood.
Having chronic hepatitis C infection without having completed curative treatment, or having a detectable amount of hepatitis C virus in the blood.
Having an active infection that needed IV antibiotics, antiviral, or antifungal medicines within the last four weeks.
Having a history of Stevens‑Johnson syndrome or toxic epidermal necrolysis (serious skin reactions).
Not having recovered from previous treatment side effects to a mild level (Grade 1) for most problems, or to a mild level (Grade 2) for nerve problems or hair loss, before screening.
Having symptoms from cancer that has spread to the brain or spinal fluid (symptomatic CNS metastases or leptomeningeal disease). Treated, symptom‑free brain metastases are allowed if the last treatment was at least four weeks ago.
Having a large amount of fluid buildup that needs drainage (such as ascites in the abdomen) or fluid causing shortness of breath.
Having active diarrhea that is moderate or worse (Grade 2 or higher) or a condition that causes chronic diarrhea (like irritable bowel syndrome or inflammatory bowel disease).
Having a bleeding disorder or taking blood thinners that keep the INR (a blood clotting test) above 2.
Having an active infection that requires systemic (whole‑body) antibiotics, antiviral, or antifungal treatment.
Being pregnant or breastfeeding.
Having serious other health problems, such as uncontrolled high blood pressure (systolic ≥ 160 mmHg or diastolic ≥ 110 mmHg), unstable chest pain, heart failure beyond mild‑moderate level, recent heart attack or procedures (within six months), uncontrolled irregular heart rhythm, poorly controlled diabetes, active stomach ulcer or bleeding, or severe chronic lung disease.
Having significant eye surface disease at the start of the study (checked by an eye doctor). Mild dry eye or eyelid inflammation that is treated with artificial tears is allowed.
Having had major surgery, radiation, chemotherapy, or other cancer treatments within 14 days before the first dose of the study drug, unless the study sponsor allows a shorter wait. For certain chemotherapy drugs with delayed side effects, a 4‑week wait is needed; for stem‑cell or CAR‑T cell transplants, a 60‑day wait is needed.
Using any other experimental medication within 14 days before the first dose of the study drug.
Having a congenital long QT syndrome (a heart rhythm condition) or a corrected QTcF interval of 480 ms or longer on the screening ECG (unless caused by a pacemaker or heart block).
Having another active cancer that is not a non‑melanoma skin cancer, non‑metastatic prostate cancer, in‑situ cervical cancer, or in‑situ breast cancer.
Planning to receive a live vaccine (a vaccine that contains a weakened form of the virus) within 30 days before the first dose or during the study.
Having any other important medical illness, abnormality, or condition that the doctor believes would make participation unsafe or inappropriate.
Testing positive for SARS‑CoV‑2 (COVID‑19) by a PCR or rapid antigen test on the day of the first dose. A negative test is required; if positive, a repeat test after 7–14 days is needed.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Hisiwfpk Virb dcitiiwa	Barcelona	Spain
Hlhoqwqd Ugdarzafziwrn Fqpgqkgln Jgjrbqs Dbyq	Madrid	Spain
Hcnybhjz Uhkygdieolser 1l Dd Opvgvfl	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.07.2022

Trial locations

ADCT-901 is an experimental medicine being tested for the first time in people with certain advanced solid cancers. In this study the drug is given through a vein (intravenous infusion) as a powder that is mixed with a liquid to create a solution for the infusion. Researchers are looking at how safe the medicine is, how well patients can tolerate it, how the drug moves through the body, and whether it can shrink or stop the growth of tumors when used alone. The goal is to find the best dose to use in later studies and to understand any side effects.

Investigated Diseases:

Neoplasm malignant

Advanced solid tumors – Advanced solid tumors are cancers that develop as a mass in an organ or tissue and have grown beyond their original site. They often spread to other parts of the body, resulting in a more widespread disease. Over time the tumors usually increase in size and may involve additional organs or tissues. The condition typically progresses with a rising tumor burden and worsening related symptoms.

Trial ID:

2022-500115-39-00

Protocol code:

ADCT-901-101

Trial Phase:

Human Pharmacology (Phase I) – First administration to humans

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Phase 1 Study of ADCT-901 in Patients with Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Antitumor Activity

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?