A Phase II Study of Ivonescimab Combined With Intraperitoneal Paclitaxel in Patients With High-Grade Metastatic Appendiceal Adenocarcinoma (AA)

NCT07753824 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2026-0801NCI-2026-05817
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety and effectiveness of Ivonescimab combined with intraperitoneal paclitaxel (IP PTX) in patients with unresectable metastatic high-grade Appendiceal Adenocarcinoma (AA).

Conditions

Phase II; Ivonescimab; Intraperitoneal; Paclitaxel; High Grade Metastatic; Appendiceal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs).

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

PTX + IVO

EXPERIMENTAL

Treatment with Paclitaxel (IP) + Ivonescimab (IV)

Drug: Ivonescimab; Drug: IP PTX

Interventions

Ivonescimab DRUG

Given by IV

PTX + IVO

IP PTX DRUG

Given by IP port

PTX + IVO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and above. There will be no upper age restriction
• ECOG performance status 0-2
• Participants must have histologically confirmed diagnosis of unresectable metastatic AA. The determination of appendiceal origin may rely on pathologic features combined with clinical or radiographic evidence in the event that the appendix remains in situ.
• Participants will have undergone no more than two prior lines of systemic therapy. The last dose of systemic therapy will have been no less than 2 weeks prior to initiation of therapy.
• Participants must have adequate nutrition and normal bowel motility and function as evidenced by albumin \> 3.0 and no history of intestinal bypass or diverting enterostomy.
• Demonstrate adequate organ function as determined by the following requirements:
• o Hematology
• No use of any blood components and cell growth factor supportive therapy within 7 days prior to initiation of study treatment
• Absolute neutrophil count (ANC) ≥ 1,500/mm3 (ANC ≥ 1000/mm3 for African American participants)
• Platelet count ≥ 100 × 109/L (100,000/mm3)
• Hemoglobin ≥ 9.0 g/dL.
• o Kidney:
• Creatinine clearance\* (CrCL) ≥ 50 mL/min using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥50 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (adjustment by body surface area \[BSA\] is not required for eGFR). \*CrCL or eGFR can be determined using the calculator from the National Kidney Foundation website (www.kidney.org).
• Urine protein \< 2+ or 24-hour urine protein quantification \< 1.0 g
• o Liver:

You may not qualify if:

• Metastases outside the peritoneal cavity, with exception of limited metastases to the thoracic cavity and/or limited retroperitoneal lymphadenopathy
• Previous surgery that would preclude safe diagnostic laparoscopy with port placement
• Current presence of significant radiographic or clinical/radiographic manifestations of gastrointestinal obstruction. History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to enrollment
• Unresolved clinically significant toxicity of greater than or equal to NCI CTCAE v. 6.0 grade 2 attributed to any prior therapies (excluding anemia, lymphopenia, alopecia, skin pigmentation).
• Other prior malignancy unless the participant has undergone curative therapy with no evidence of disease recurrence within 3 years prior to enrollment. The following malignancies will be allowed without the 3-year interval after adequate treatment: basal cell or squamous cell carcinoma of skin, superficial bladder cancer, in situ cervical cancer, other in situ cancers, prostate cancer with a Gleason score ≤6 that does not need therapy or other local tumors that are considered cured
• Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period for an interventional study.
• Palliative local therapy for non-target lesions and non-specific immunomodulatory therapy (such as interleukin, interferon, thymus peptide, tumor necrosis factor, etc.) within 2 weeks before the first dose.
• Any prior clinically significant or active autoimmune disease requiring systemic therapy (e.g., with disease- modifying drugs, prednisone \>10 mg daily or equivalent, immunosuppressant therapy or immunomodulatory agents \[e.g., infliximab or IVIG\]) within 2 years prior to enrollment; however, replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.
• History of major diseases before enrollment, specifically:
• Unstable angina, myocardial infarction, CHF (New York Heart Association \[NYHA\] classification ≥Grade 2) or unstable vascular disease (e.g., aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to enrollment, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia)
• History of esophageal gastric varices, severe ulcers, wounds that do not heal, fistula, intra-abdominal abscesses, or ≥ Grade 3 acute gastrointestinal bleeding within 6 months before enrollment
• History of any grade arterial thromboembolic event (ATE), Grade 3 and above venous thromboembolism (VTE), as specified in NCI CTCAE6.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to enrollmentAcute exacerbation of chronic obstructive pulmonary disease within 4 weeks before enrollment
• Live vaccine or live attenuated vaccine within 4 weeks prior to planned enrollment, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted.
• Severe infection within 4 weeks prior to enrolment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the Investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrollment (excluding antiviral therapy for hepatitis B).
• Major surgical procedures or serious trauma within 4 weeks prior to enrollment or plans for major surgical procedures within 4 weeks after the first dose (as determined by the Investigator). Minor local procedures within 3 days prior to enrollment (excluding central venous catheterization and port implantation).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Cancer Prevention Research Institute of Texas: collaborator
• Summit Therapeutics: collaborator

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Adenocarcinoma, Mucinous

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): January 16, 2027
• Primary Completion (Estimated): November 28, 2031
• Study Completion (Estimated): November 28, 2032
• Last Updated: August 10, 2026

Record last verified: 2026-07