Clinical trial · Interventional
RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma
A Phase I, Multi-Dose Study of RAV12 (ANTI-RAAG12 MAB) in Patients With Metastatic or Recurrent Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best dose of RAV12 in treating patients with metastatic or recurrent adenocarcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| monoclonal antibody RAV12 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RAV12
- interventionNames
- Biological: monoclonal antibody RAV12
Primary outcomes (1)
- measure
- Toxicity by CTCAE
- timeFrame
- Days 1-50
Secondary outcomes (5)
- measure
- Maximum tolerated dose
- timeFrame
- Days 1-50
- measure
- Pharmacokinetics of RAV12 by serum levels
- timeFrame
- Days 1, 2, 4, 5, 8, 15, 22, 29, 36, 43, and 50
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma * Metastatic or recurrent disease * Not curable by standard therapies * Must have failed at least 1, but no more than 3, prior therapies for metastatic or recurrent disease * Patients with colorectal or breast adenocarcinoma must have failed at least 2 prior therapies * Must have had at least stable disease for 3 months while on last treatment prior to most recent disease progression * Meets 1 of the following criteria: * At least 1 measurable site of disease ≥ 2 cm by radiography * Evaluable disease that could be reliably and consistently followed, as deemed by the principal investigator * RAAG12 expression confirmed\* by immunohistochemistry NOTE: \*Not required for patients with colon, pancreatic, or gastric adenocarcinoma * No evidence of residual or recurrent CNS metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Not specified Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL (transfusions allowed) * Absolute neutrophil count ≥ 1,500/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * γ-glutamyl transferase ≤ 2.5 times ULN * Adequate hepatic function sufficient to undergo study therapy Renal * Creatinine \< 1.5 mg/dL * Adequate renal function sufficient to undergo study therapy Cardiovascular * No New York Heart Association class III or IV heart disease * No thrombosis within the past 3 months, including any of the following: * Deep vein thrombosis * Myocardial infarction * Stroke * Adequate cardiac function sufficient to undergo study therapy Pulmonary * No pulmonary embolism within the past 3 months * No significant pulmonary compromise, particularly dependence on supplemental oxygen on an as-needed or continuous basis * Adequate pulmonary function sufficient to undergo study therapy Immunologic * No active viral, bacterial or systemic fungal infection requiring parenteral therapy within the past 4 weeks * No history of chronic or recurrent infection requiring continual antiviral, antifungal, or antibacterial agents * No known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in study drug Other * Amylase and lipase normal * No other primary malignancy within the past 3 years except for the following: * Treated non-melanoma skin cancer * Carcinoma in situ of the cervix by biopsy * Squamous intraepithelial lesion of the cervix by PAP smear * Localized prostate cancer (Gleason score \< 6) * Resected melanoma in situ * No other serious medical condition that would preclude study participation * No dementia or altered mental status that would preclude giving informed consent * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 half-lives since prior monoclonal antibody therapy * No concurrent vaccinations * No concurrent prophylactic hematologic growth factors Chemotherapy * At least 4 weeks since prior chemotherapy Endocrine therapy * No concurrent steroids except for the following: * Inhaled, ophthalmic, or nasal steroids * Stable dose of oral prednisone (or equivalent) ≤ 10 mg/day Radiotherapy * At least 4 weeks since prior radiotherapy Surgery * More than 4 weeks since prior major surgery Other * More than 4 weeks since prior investigational agents * Prior oral antiviral, antifungal, or antibacterial therapy allowed provided therapy was completed within the past week * No other concurrent antineoplastic therapy * No concurrent immunosuppressive medications * No other concurrent investigational agents * No concurrent vitamins except those approved by the medical monitor * Concurrent daily multivitamin allowed * Concurrent bisphosphonates allowed provided patient is on stable dose for ≥ 1 month prior to study entry
References
Publications (1)
- RESULTBurris HA 3rd, Rosen LS, Rocha-Lima CM, Marshall J, Jones S, Cohen RB, Kunkel LA, Loo D, Baughman J, Stewart SJ, Lewis N. Phase 1 experience with an anti-glycotope monoclonal antibody, RAV12, in recurrent adenocarcinoma. Clin Cancer Res. 2010 Mar 1;16(5):1673-81. doi: 10.1158/1078-0432.CCR-09-2263. Epub 2010 Feb 23. PMID 20179219