A First-in-human Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and P… (NCT07688148) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A First-in-human Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumour Activity of TAX2 in Patients With Relapsed/Refractory Advanced/Metastatic Solid Tumours
Belgium, France48 participantsStarted 2026-10
Plain-language summary
The purpose of this clinical trial is to investigate the treatment for adult patients suffering from advanced or metastatic solid tumours and has 2 parts to the study: the Phase 1 where ascending doses of the experimental study drug, TAX2, will be tested and the Phase 2a where all the participants will receive the study drug at the same dose considered as the recommended Phase 2 dose from Phase 1 part. The participation in the Phase 1 or in the Phase 2a part depends on when the participant is proposed to join the study.
The study purpose is to assess:
* How safe and tolerable TAX2 is. This assessment will be based on the adverse effects collected during the study.
* How well TAX2 enters the body, circulates in the body, and leaves the body (known as pharmacokinetics, PK) by measuring the level of the drug in the blood
* What the drug does with the body and the tumour (known as pharmacodynamics, PD)
* The effect TAX2 has on the tumours (anti-tumour activity)
* Also define the Dose Limiting Toxicity (DLT) and the recommended Phase 2 Dose (RP2D)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Relapsed/refractory advanced/metastatic ovarian cancer (aOC). All histological types of OC are eligible, including ovarian clear cell carcinoma and with exception of mucinous ovarian subtypes.
. Relapsed/refractory metastatic colorectal cancer (mCRC). All histological types of CRC are eligible.
. Relapsed/refractory metastatic pancreatic cancer (mPC). All histological types of PC are eligible, with the exception of pancreatic neuro-endocrine tumours.
. Relapsed/refractory cutaneous metastatic melanoma (MM). All histological types of cutaneous melanoma are eligible.
. A male participant must agree to use highly effective contraception (as described below) from the time of screening to at least 3 months after the last dose of trial treatment. During this period, he must refrain from donating sperm.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients with DLTs _ Phase 1
Timeframe: From enrollment to the end of Cycle 1 (each cycle is 28 days)
2
Safety and tolerability to be determined based on the frequency and number of patients with AEs
Timeframe: From enrollment to the end of Cycle 1 (each cycle is 28 days)
. A female participant must not be pregnant nor breastfeeding and either is not a woman of childbearing potential (WOCBP; i.e. not post-menopausal for ≥ 1 year and not surgically sterile) or must agree to use highly effective contraception (as described below) from the time of screening to at least 6 months after the last dose of trial treatment. During this period, she must refrain from participation in in vitro fertilisation.
. A WOCBP must agree to repeated pregnancy testing during trial participation. She must have a negative serum pregnancy test (beta-HCG) within 48 hours prior to start of trial treatment.
. Highly effective contraception includes combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, and/or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner or sexual abstinence.
Exclusion criteria
. Evidence of poorly controlled arterial hypertension (systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg).
. Documented history of congestive heart failure of New York Heart Association Grade III or IV or presence of left ventricular ejection fraction (LVEF) of \< 50% during echocardiography or MUGA scan at screening.
. Any cardiac arrhythmia that is not well controlled.
. Clinically significant valvular heart disease.
. Unstable angina pectoris within 6 months prior to start of trial treatment. E.08 History or presence of severe dyspnoea, pulmonary dysfunction, or need for continuous supportive oxygen inhalation.
. Malignancy treated with curative intent, with no known active disease for at least 2 years prior to start of trial treatment, and with a relatively low risk for recurrence.
. Adequately treated non-melanoma skin cancer or lentigo maligna without current evidence of disease.
. Adequately treated carcinoma in situ (including ductal carcinoma of the breast, DCIS) without current evidence of disease.