Actively Recruiting
Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis
Led by Alethia Biotherapeutics · Updated on 2025-02-19
17
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. One cycle of treatment will consist of 14 days (2 weeks).
CONDITIONS
Official Title
Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older.
- Diagnosis of stage IV colon or rectal adenocarcinoma with resectable liver-dominant metastases.
- Candidates for neoadjuvant FOLFOX chemotherapy followed by partial liver resection.
- May have had prior primary tumor resection or will have it during or after liver surgery.
- No prior chemotherapy for metastatic disease; prior adjuvant chemotherapy/radiotherapy allowed if completed at least 12 months before enrollment.
- At least one measurable lesion according to RECIST 1.1.
- Liver metastasis suitable for biopsy with no biopsy contraindications.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Recovery from recent cancer treatment toxicities to Grade 1 or less.
- Life expectancy of at least 3 months.
- Adequate organ and immune function.
- Negative pregnancy test within 72 hours prior to first treatment dose for females of childbearing potential.
- Willingness to use effective contraception during the trial and for 90 days after last dose.
- Females not considered childbearing if surgically sterile or post-menopausal based on defined criteria.
- Ability and willingness to comply with trial procedures and follow-up.
- Signed informed consent following Good Clinical Practice guidelines.
You will not qualify if you...
- Prior treatment with sotevtamab.
- Concurrent use of anti-VEGFR, anti-EGFR, anti-VEGF, or other biological/targeted therapies with neoadjuvant FOLFOX.
- Presence of mismatch repair-deficient primary colorectal tumor.
- Hereditary colorectal cancer syndromes (e.g., familial colonic polyposis or Lynch syndrome).
- Another progressing malignancy requiring active treatment (exceptions: certain skin cancers and in situ cervical cancer).
- Need for other systemic or localized cancer therapies during the trial.
- Use of prednisone >10 mg/day or other immunosuppressive drugs within 7 days before first dose.
- Participation in another investigational trial or device study within 21 days before first dose.
- Pre-existing peripheral neuropathy with functional impairment.
- Significant abnormalities on electrocardiogram (ECG).
- Receipt of live vaccine within 30 days before first study treatment.
- Known HIV infection.
- Active hepatitis B or C infection.
- Active infection requiring antibiotics.
- History of alcohol or substance abuse within the past year.
- Known allergy to FOLFOX chemotherapy.
- Any condition or abnormality that could affect study results or participant safety.
- Medical, social, or psychosocial factors affecting safety or compliance.
- Pregnant, lactating, or planning to conceive/father children during the trial and specified post-treatment periods.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
Research Team
J
Julie Laurin, B. Pharm, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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