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A Study to Assess the Adverse Events and Change in Disease Activity of Multiple Treatment Combinations with Telisotuzumab Adizutecan in Participants with Metastatic Colorectal Cancer
EU CTIS ID: 2024-512981-33-00
What this study is testing
1) To evaluate the efficacy of telisotuzumab adizutecan combinations as compared to standard of care treatment in Metastatic colorectal cancer (mCRC). 2) To evaluate the safety and tolerability of telisotuzumab adizutecan combinations. 3) To optimize the telisotuzumab adizutecan dose in combination regimens to determine the recommended Phase 3 dose (RP3D) in applicable substudies.
- Therapeutic exploratory (Phase II)
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
- Substudy 1 and 2: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Substudy 1 and 2: QTc < 470 msec (using Fridericia's correction), no Grade 3 arrythmia, and no other clinically significant cardiac abnormalities.
- Substudy 1 and 2: Participant has histologically or cytologically confirmed mCRC.
- Substudy 1 and 2: Participant has measurable disease per RECIST v1.1.
- Substudy 2: Left sided primary tumor
You likely can't join if
- Substudy 1 and 2: Prior systemic therapy for mCRC.
- Substudy 1 and 2: History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis that required treatment with systemic steroids, or idiopathic pneumonitis.
- Substudy 1 and 2: History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%).
- Substudy 2: History of treatment with any anti-EGFR treatments (cetuximab or panitumumab).
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Puerto Rico
- United Kingdom
- United States
- Brazil
- Japan
- Taiwan
- Israel
- Australia
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.
Where is this trial taking place?
Study sites include Canada; Puerto Rico; United Kingdom; United States; Brazil; Japan and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.