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New treatment option for Metastatic Colorectal Cancer
Official title Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis
ClinicalTrials.gov ID: NCT06225843
What this study is testing
What is Sotevtamab?
Sotevtamab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer.
Also referred to as AB-16B5.
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 Phase II study will recruit 17 colorectal cancer patients with liver-dominant metastases. All recruited patients will receive Sotevtamab at a dose of 800 mg once weekly for 6 cycles combined with FOLFOX once every 2 weeks for the first 4 cycles followed by liver metastases resection surgery with or without primary cancer resection.
- Phase 2: a mid-size study of how well it works
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
- Participants (male or non-pregnant female) must be ≥ 18 years of age on the day of signing the informed consent.
- Participants with stage IV colon or rectal adenocarcinoma with resectable liver-dominant metastases and candidate to neoadjuvant FOLFOX followed by...
- Participants may have had resection of their primary colon or rectal adenocarcinoma in the past or will have their primary cancer resected at the...
- Participants must not have received prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy and radiotherapy following resection of...
- For multiple liver metastases, participants may undergo liver metastases needle-ablation of some metastases combined with surgical resection of...
You likely can't join if
- Participants who have received prior therapy with sotevtamab
- Concurrent administration of anti-VGFR, anti-EGFR, anti-VEGF or other biological or targeted therapy with neoadjuvant FOLFOX
- Participants with MMR-deficient primary colorectal tumor
- Hereditary colorectal cancer (e.g., familial colonic polyposis or Lynch syndrome)
- Participants who have another malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin...
- Participants who are expected to require any other form of systemic or localized antineoplastic therapy while on the trial. This includes maintenance...
See the full eligibility criteria
Who can join
- Participants (male or non-pregnant female) must be ≥ 18 years of age on the day of signing the informed consent.
- Participants with stage IV colon or rectal adenocarcinoma with resectable liver-dominant metastases and candidate to neoadjuvant FOLFOX followed by partial hepatectomy.
- Participants may have had resection of their primary colon or rectal adenocarcinoma in the past or will have their primary cancer resected at the same time as the liver metastases resection or after liver metastases...
- Participants must not have received prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy and radiotherapy following resection of primary tumor is acceptable if completed at least 12 months prior to...
- For multiple liver metastases, participants may undergo liver metastases needle-ablation of some metastases combined with surgical resection of others, as long as at least one metastasis is surgically resected.
- Participants with at least one measurable lesion according to RECIST 1.1.
- Participants must have a liver metastasis amenable for biopsy with no contraindication for biopsy.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Participants must have recovered from the toxic effects resulting from the most recent cancer treatment to Grade 1 or less. If the participants underwent major surgery, they must have recovered from the complications...
- Participants must have a life expectancy of at least 3 months.
- Participants must have adequate organ and immune function
- Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of trial treatment.
- Participants (both male and female) of reproductive potential must be willing to practice highly effective methods of contraception throughout the trial and for up to 90 days after the last dose of trial medication...
- Female participants are not considered of childbearing potential if they have a history of surgical sterility or evidence of post-menopausal status defined as any of the following: i. ≥ 45 years of age and has not had...
- Participants must understand and be able and willing and likely to fully comply with the trial procedures, including scheduled follow-up, and restrictions.
- Participants must have given written personally signed and dated informed consent to participate in the trial in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP)...
What rules you out
- Participants who have received prior therapy with sotevtamab
- Concurrent administration of anti-VGFR, anti-EGFR, anti-VEGF or other biological or targeted therapy with neoadjuvant FOLFOX
- Participants with MMR-deficient primary colorectal tumor
- Hereditary colorectal cancer (e.g., familial colonic polyposis or Lynch syndrome)
- Participants who have another malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer.
- Participants who are expected to require any other form of systemic or localized antineoplastic therapy while on the trial. This includes maintenance therapy with another agent or radiation therapy.
- Participants who are receiving a dose \> 10 mg/day of prednisone (or equivalent) within 7 days prior to the first dose of study treatment or any other form of immunosuppressive medication.
- Participants who are currently participating or have participated in a trial of an investigational agent or using an investigational device within 21 days of the first dose of trial treatment. The 21-day window should...
- Participants who have a pre-existing peripheral sensitive neuropathy with functional impairment.
- Participants with clinically significant electrocardiogram (ECG) abnormalities.
- Participants who have received or will receive a live vaccine with 30 days prior to the first dose of trial treatment.
- Participants with a known history of human immunodeficiency (HIV).
- Participants with an active Hepatitis B or C infection.
- Participants with an active infection requiring antibiotic therapy.
- Participants with a known history of alcohol or other substance abuse within the last year.
- Participants with known hypersensitivity to FOLFOX.
- Participants who have a history or current evidence of any condition, therapy or laboratory abnormalities that may confound the results of the trial, interfere with the participant's participation for the full duration...
- Participants with medical, social or psychosocial factors that, in the opinion of the treating Investigator, could impact the safety or compliance with trial procedures.
- Participants who are pregnant or lactating or who are expecting to conceive or father children within the projected duration of the trial through 90 days after the last dose of sotevtamab or 180 days after the last dose...
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. 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.