BridgeMD
A randomized, open label, multicenter phase II/III trial of sacituzumab govitecan compared to standard of care in metastatic, refractory colorectal cancer patients (TROPHIT1)
EU CTIS ID: 2023-509771-17-00
What this study is testing
The overall objective of the trial is to investigate the efficacy of the antibody-drug conjugate Sacituzumab Govitecan (SG), a TROP2 targeted approach, in individuals diagnosed with Metastatic Colorectal cancer (mCRC). The first single-arm part (PART I) of the trial investigates efficacy assessed by progression free survival. In case of high clinical efficacy, the second randomized part (PART II) investigates superiority of SG compared to standard of care (Physicians Choice).
- Phase II and Phase III (Integrated)
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
- Diagnosis of UICC Stage IV mCRC, not eligible for local therapy
- Women or men aged ≥ 18 years, no upper age limit
- ECOG performance status ≤2
- Patients must have failed standard therapy or were intolerable towards standard therapy which must include fluoropyrimidine, oxaliplatin and irinotecan. (Targeted therapies (in combination with chemotherapy) including antiangiogenic monoclonal antibody/fusion protein/small molecule (e.g. bevacizumab, aflibercept, ramucirumab) and anti-EGFR antibody (e.g. Cetuximab, Panitumumab) are allowed as previous therapies.)
- No Irinotecan treatment within the last 6 months. Patients that received Irinotecan treatment more than 6 months prior to inclusion, must have been responsive to Irinotecan induction therapy (i.e., patients previously exposed to induction chemotherapy containing irinotecan must have presented CR or PR or else SD at least 3 months or at initial response assessment).
- At least one measurable lesion according to RECIST 1.1 that can be accurately assessed at screening by computed tomography or magnetic resonance imaging and is suitable for repeated assessment or available CT scan of thorax and abdomen not older than 30 days before start of treatment (day 1 of cycle 1).
You likely can't join if
- Patient with a known hypersensitivity to any of the excipients of sacituzumab govitecan
- Known microsatellite instable (MSI-H) / MMR-protein deficient (dMMR) colorectal cancer.
- Pregnancy and lactation
- Participation in other clinical trials involving an investigational drug(s) (Phases 1-4) or observation period of competing trials, respectively within 4 weeks prior to study entry. Patients participating in observational studies are eligible.
- Taking medications that may interfere with SN-38 metabolism.
- Have had a prior anticancer biologic agent within 2 weeks prior to enrollment or have had prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to enrollment AND have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs at the time of study entry.
See the full eligibility criteria
- Diagnosis of UICC Stage IV mCRC, not eligible for local therapy
- Women or men aged ≥ 18 years, no upper age limit
- ECOG performance status ≤2
- Patients must have failed standard therapy or were intolerable towards standard therapy which must include fluoropyrimidine, oxaliplatin and irinotecan. (Targeted therapies (in combination with chemotherapy) including antiangiogenic monoclonal antibody/fusion protein/small molecule (e.g. bevacizumab, aflibercept, ramucirumab) and anti-EGFR antibody (e.g. Cetuximab, Panitumumab) are allowed as previous therapies.)
- No Irinotecan treatment within the last 6 months. Patients that received Irinotecan treatment more than 6 months prior to inclusion, must have been responsive to Irinotecan induction therapy (i.e., patients previously exposed to induction chemotherapy containing irinotecan must have presented CR or PR or else SD at least 3 months or at initial response assessment).
- At least one measurable lesion according to RECIST 1.1 that can be accurately assessed at screening by computed tomography or magnetic resonance imaging and is suitable for repeated assessment or available CT scan of thorax and abdomen not older than 30 days before start of treatment (day 1 of cycle 1).
- Patient with a known hypersensitivity to any of the excipients of sacituzumab govitecan
- Known microsatellite instable (MSI-H) / MMR-protein deficient (dMMR) colorectal cancer.
- Pregnancy and lactation
- Participation in other clinical trials involving an investigational drug(s) (Phases 1-4) or observation period of competing trials, respectively within 4 weeks prior to study entry. Patients participating in observational studies are eligible.
- Taking medications that may interfere with SN-38 metabolism.
- Have had a prior anticancer biologic agent within 2 weeks prior to enrollment or have had prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to enrollment AND have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs at the time of study entry.
- Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent.
- Have an active second malignancy.
- History of significant cardiovascular disease ( NYHA ≥ III)
- Clinical signs of active severe infection with or without requiring antibiotics.
- Inadequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment (growth factor support is not allowed within 14 days prior to baseline labs
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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.