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NCT07284277Phase 1, Phase 2Recruiting

TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)

Clinica Universidad de Navarra, Universidad de Navarra · Clínica Universidad de Navarra, Pamplona, Navarre

The purpose of this clinical trial is to assess the safety and tolerability of TTFields in combination with chemotherapy in adults with metastatic pancreatic adenocarcinoma based on treatment-emergent adverse events of chemotherapy (modFOLFIRINOX) or device (TTFields). The main questions it aims to answer are: * Is TTFields treatment safe for the patients in combination with modFOLFIRINOX? * Are participants compliant with the treatment? * Is Is TTFields treatment effective in combination with modFOLFIRINOX against metastatic pancreatic adenocarcinoma?

Eligibility: 18 Years to · All · All the patients should comply with the following criteria for inclusion: 1. Histological/cytological diagnosis of pancreatic adenocarcinoma. 2. The patient should be 18 years of age and older. 3. The patient has given consent to participate in the study. 4. The patient should be able to comply with all the requirements of the clinical trial. 5. Life expectancy of at least 3 months. 6. Metastatic disease with, at least, one hepatic lesion that must be accessible for biopsy. 7. Measurable disease as defined by Response Evaluation Criteria in Solid Tumor v1.1 (RECIST 1.1) apart from the liver lesion to be biopsied. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 9. Amenable and assigned by the investigator to receive therapy with modFOLFIRINOX. 10. Prior chemotherapy or radiotherapy on the neoadjuvant or adjuvant setting is allowed as long as at least six months have elapsed since last chemotherapy treatment. 11. Able to operate the Novo TTF-200T System independently or with the help of a caregiver. 12. Adequate hematologic and organ function, defined by the following laboratory test results, obtained during the screening period and before C1D1. 1. WBC higher than or equal to 2.5 x 10\^9/L. 2. ANC higher than or equal to 1.5 x 10\^9/L without granulocyte colony-stimulating factor support. 3. Platelet count higher than or equal to 100 x 10\^9/L without transfusion. 4. Hemoglobin higher than or equal to 9 g/dL. Patients may be transfused to meet this criterion. 5. Albumin higher than or equal to 2.5 g/dL. 6. Serum bilirubin lower than or equal to 1.5 times the upper limit of normal (ULN); patients with known Gilbert´s disease may have a bilirubin value lower than or equal to 3 x ULN. 7. INR and aPTT lower than or equal to 1.5 x ULN. 8. AST, ALT, lower than or equal to 5 x ULN. 9. Serum creatinine lower than or equal to 1.5 x ULN or Creatinine Clearance higher than or equal to 30ml/min (calculated using Cockcroft-Gault formula). 13. For women of childbearing potential: Negative serum pregnancy test within 14 days prior to C1D1. Agreement to remain abstinent (refrain from heterosexual intercourse) or use of contraceptive methods that result in a failure rate of lower than or equal to 1 percentage per year during the treatment period (combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal o transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable o implantable); intrauterine device (IUD) or intrauterine hormone-releasing system (IUS); bilateral tubal occlusion or vasectomized partner) and for at least 180 days after the last study treatment. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (higher than or equal to 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).

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NCT07702032Phase 3Recruiting

Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)

Genmab · Low Country Cancer Care Associates_Savannah_1, Savannah, Georgia

The purpose of this trial is to evaluate how well petosemtamab in combination with chemotherapy works against colorectal cancer located on the left side of the colon that cannot be safely removed by surgery or has spread to other parts of the body. Participants will receive either petosemtamab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI) or standard-of-care cetuximab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI). No participants will be given placebo. The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participants will be asked to attend 2 visits at the study clinic for each cycle (duration of cycle is 4 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) will be different for every participant.

Eligibility: 18 Years to · All · Key * Histologically or cytologically confirmed left-sided colorectal adenocarcinoma that is unresectable or metastatic. * Must have documented KRAS and NRAS wild type (wt) colorectal cancer (CRC), as determined by medical record of results from local testing or as assessed by central testing. Local testing must have been conducted in accordance with local guidelines using an Food and Drug Administration (FDA)-approved test or a laboratory-developed test that is validated in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (sites in the United States) or an accredited local laboratory (sites outside of the United States). Next-generation sequencing (NGS)-based test results from tumor tissue are required for determining eligibility. Polymerase chain reaction (PCR)-based tests, sanger sequencing, or pyrosequencing test results are not allowed. * Has not received any prior systemic therapy for unresectable or metastatic CRC. * Must be eligible for treatment with mFOLFOX6 (if assigned to receive mFOLFOX6) or FOLFIRI (if assigned to receive FOLFIRI) according to local regulatory approvals and SOC guidelines. Key

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