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New treatment option for Metastatic Colorectal Cancer
Official title Sacituzumab Govitecan in Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT06243393
What this study is testing
What is Sacituzumab Govitecan (SG)?
Sacituzumab Govitecan (SG) is an investigational medicine, being studied as a potential treatment for metastatic colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase: II/III, open-label, multicenter (at least four centers in Germany) study of Sacituzumab Govitecan (SG) in metastatic colorectal cancer patients who are refractory to at least two lines of standard of care chemotherapy and not eligible for local therapy. There is no upper limit in the previous therapy lines.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients meeting all of the following criteria are considered for admission to the trial:
- 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...
You likely can't join if
- Patients meeting any of the following criteria are not eligible for the trial:
- Patient with a known hypersensitivity to any of the excipients of sacituzumab govitecan
- Participation in other clinical trials involving an investigational drug(s) (Phases 1-4) or observation period of competing trials, respectively...
- 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...
- Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent. Note: patients with any grade...
See the full eligibility criteria
- Patients meeting all of the following criteria are considered for admission to the trial:
- 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...
- 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...
- 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...
- Written informed consent
- Non-pregnant and non-nursing women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to start of study treatment. A...
- Amenorrhea for at least 12 consecutive months without an alternative medical cause following cessation of exogenous hormonal treatments.
- Chemotherapy-induced menopause with \>1 year interval since last menses
- Surgical sterilisation
- WOCBP are to be advised using two effective methods of birth control to avoid pregnancy throughout the study and for at least 6 months after the last dose of IMP. This includes effective contraception methods that can...
- Fertile men should not donate sperm and must be willing and able to use two effective methods of birth control (e.g latex condoms plus hormonal contraception in their partner) throughout the study and for at least 6...
- Patients meeting any of the following criteria are not eligible for the trial:
- Patient with a known hypersensitivity to any of the excipients of sacituzumab govitecan
- 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...
- 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...
- Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent. Note: patients with any grade neuropathy or alopecia are an exception to this criterion and will qualify...
- Have an active second malignancy. Note: patients with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured...
- History of significant cardiovascular disease ( NYHA ≥ III)
- Clinical signs of active severe infection with or without requiring antibiotics.
- Have known history of HIV-1 or 2 (or positive HIV-1/2 antibody, if done at screening) with detectable viral load
- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.
- Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for...
- Patients who test positive for HCV antibody. Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive...
- 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; Hemoglobin \ 1.5 times...
- Known microsatellite instable (MSI-H) / MMR-protein deficient (dMMR) colorectal cancer.
- Any medical or other condition which, in the opinion of the Investigator, causes the subject to be medically unfit to receive sacituzumab govitecan, or unsuitable for any other reason
- Pregnancy and lactation
- Inability of patient to understand character and consequences of the clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Baden-Wurttemberg, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heidelberg, Baden-Wurttemberg, Germany. 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 ClinicalTrials.gov; the study team decides eligibility.