Clinical trial · Interventional
Maytansinoid DM4-Conjugated Humanized Monoclonal Antibody huC242 in Treating Patients With Solid Tumors
A Phase I Study to Assess the Safety and Pharmacokinetics of huC242-DM4 Administered as a Single Intravenous Infusion Once Every Three Weeks to Subjects With Solid Tumors
- 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 maytansinoid DM4-conjugated humanized monoclonal antibody huC242, 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 maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in treating patients with solid tumors that cannot be removed by surgery or have spread to other parts of the body.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-colorectal Cancer | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HuC242-DM4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Dose-limiting toxicity
- timeFrame
- for the duration of the trial
- measure
- Maximum tolerated dose
- timeFrame
- for the duration of the trial
Secondary outcomes (3)
- measure
- Toxicity
- timeFrame
- for the duration of the trial
- measure
- Pharmacokinetics
- timeFrame
- for the duration of the trial
- measure
- Antitumor activity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor * Inoperable or metastatic disease * Failed standard therapy * Confirmed cancer antigen (CanAg) expression * Patients must have non-colorectal cancer or pancreatic cancer * Tumor must have a homogeneous pattern (i.e., staining present in \> 75% of tumor cells for CanAg) and are 2+ or 3+ intensity by immunohistochemistry \* No known leptomeningeal disease or progressive brain disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * Absolute neutrophil count ≥ 1,500/mm³ * Hemoglobin ≥ 9 g/dL (transfusion allowed) * Platelet count ≥ 100,000/mm³ * aPTT and INR ≤ 1.5 times upper limit of normal (ULN) * Creatinine ≤ 1.5 mg/dL * Creatinine clearance ≥ 60 mL/min * Bilirubin ≤ 1.5 mg/dL * AST and ALT \< 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 30 days after completion of study treatment * No hypersensitivity to agents of the same class as the study drug, humanized or nonhumanized antibodies, or immunoconjugates * No active, uncontrolled infection * No hepatitis B surface antigen or hepatitis C antibody positivity * No history of alcoholic liver disease * No serious medical or psychiatric disorder that would preclude compliance with study requirements * No peripheral neuropathy \> grade 1 * No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer * No severe concurrent disease or condition that, in the opinion of the investigator, would preclude study participation PRIOR CONCURRENT THERAPY: * Recovered from prior therapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) * At least 4 weeks since prior radiotherapy, immunotherapy, or hormone therapy for cancer * At least 4 weeks since prior major surgery * No concurrent chemotherapy, other immunotherapy, radiotherapy, or other investigational therapy * Palliative radiotherapy for related bone metastases allowed * No other concurrent anticancer therapy
References
Publications (1)
- RESULTSankhala KK, Mita AC, Ricart AD, et al.: A phase I and pharmacokinetic study of a CanAg-targeted immunoconjugate, HuC242-DM4, in patients with CanAg-expressing solid tumors. [Abstract] American Association for Cancer Research: Molecular Targets and Cancer Therapeutics, October 22-26, 2007, San Francisco, CA A-B70, 2007.