Clinical trial · Interventional
Yttrium Y 90 DOTA Anti-CEA Monoclonal Antibody M5A in Treating Patients With Advanced Solid Tumors
A Phase I Study of Yttrium-90 Labeled Humanized Anti-CEA M5A Antibody in Patients With CEA Producing Advanced Malignancies
- 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: Radiolabeled monoclonal antibodies, such as yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A, can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for advanced cancer. PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A in treating patients with advanced solid tumors.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| high performance liquid chromatography | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| radionuclide imaging | Procedure | — | UNRESOLVED |
| single photon emission computed tomography | Procedure | — | UNRESOLVED |
| yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Y-90-DOTA-M5A anti-CEA antibody
- interventionNames
- Other: high performance liquid chromatography
- Other: pharmacological study
- Procedure: radionuclide imaging
- Procedure: single photon emission computed tomography
- Radiation: yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A
Primary outcomes (6)
- measure
- Maximum tolerated dose
- timeFrame
- 10 weeks after the beginning of the last cycle of treatment
- measure
- Toxicity
- timeFrame
- From the date of the beginning of the first cycle of treatment to 10 weeks from the date of the beginning of the last cycle of treatment
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed advanced solid tumor for which no standard or effective treatment is available * Patients who refuse an available standard but non-curative treatment may also be eligible * Tumors must produce CEA as documented by either an elevated serum CEA above the upper limit of normal (ULN) or by immunohistochemical (IHC) methods * Positive CEA IHC stain is determined if more than 30% of the tumor cells have an intensity of 2+ or greater * Measurable disease * Estimated \< 1/3 of liver involvement if tumor involves the liver * No brain or leptomeningeal involvement with cancer PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Life expectancy ≥ 3 months * WBC ≥ 4,000/μL * ANC ≥ 1,500/μL * Platelet count ≥ 125,000/μL * Creatinine ≤ 1.5 mg/dL and/or creatinine clearance \> 60 mL/min * Bilirubin ≤ 1.5 mg/dL * ALT and AST ≤ 2 times ULN * Negative pregnancy test * Fertile patients must use effective contraception * Patients currently being treated for severe infections or recovering from other intercurrent illnesses (such as poorly controlled diabetes or hypertension) are ineligible until recovery is deemed complete by the investigator * Serum anti-antibody testing must be negative for human anti-humanized antibodies (if patient received prior monoclonal antibody) * Serum HIV-negative * Serum hepatitis B antigen- and hepatitis C antibody-negative PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior radiotherapy, immunotherapy, or chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered * Recovered from prior major surgery * No prior radiotherapy to \> 50% of bone marrow * No other concurrent chemotherapy, radiotherapy, or immunotherapy
References
Publications (0)
Data not yet available