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LB−100 and azenosertib in metastatic colorectal cancer patients
EU CTIS ID: 2024-511227-33-00
What this study is testing
To determine the RP2D of LB−100 combined with azenosertib in metastatic CRC patients.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Able to understand and voluntarily sign the informed consent (IC) form.
- Patient ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histological or cytological confirmation of advanced CRC
- Patient has no curative treatment options in standard of care. This should include at least a fluoropyrimide based regimen, oxaliplatin and/or irinotecan.
- Presence of at least one measurable lesion defined by the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
You likely can't join if
- Unable to follow study procedures
- Patients using prohibited medication
- Any unresolved grade ≥ 2 toxicities related to prior treatments (excluding alopecia) according to CTCAE version 5.0
- Participants with a clinically significant gastrointestinal disorder that in the opinion of the treating investigator could impact the absorption of azenosertib
- Symptomatic or untreated leptomeningeal disease
- Symptomatic or actively progressing central nervous system metastases
See the full eligibility criteria
- Able to understand and voluntarily sign the informed consent (IC) form.
- Patient ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histological or cytological confirmation of advanced CRC
- Patient has no curative treatment options in standard of care. This should include at least a fluoropyrimide based regimen, oxaliplatin and/or irinotecan.
- Presence of at least one measurable lesion defined by the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
- Unable to follow study procedures
- Patients using prohibited medication
- Any unresolved grade ≥ 2 toxicities related to prior treatments (excluding alopecia) according to CTCAE version 5.0
- Participants with a clinically significant gastrointestinal disorder that in the opinion of the treating investigator could impact the absorption of azenosertib
- Symptomatic or untreated leptomeningeal disease
- Symptomatic or actively progressing central nervous system metastases
- History of another malignancy, exclusions are listed in the protocol
- Patient with cardiac comorbidities as listed in the protocol
- Pregnant or breast–feeding (lactating) women
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.