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A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma

C

CuraGen

Status and phase

Completed
Phase 2
Phase 1

Conditions

Unresectable Stage III or Stage IV Melanoma

Treatments

Drug: CR011-vcMMAE

Study type

Interventional

Funder types

Industry

Identifiers

NCT00412828
CR011-CLN-11

Details and patient eligibility

About

This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached. Once the MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be explored.

Enrollment

117 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female with age ≥ 18 years.

  • Progressive or new metastatic melanoma, stage III or IV.

  • Measurable disease by CT / MRI

  • Failure of no more than 1 line of prior cytotoxic therapy.

  • Adequate bone marrow, renal and hepatic function

    • Leukocytes ≥ 3000/mm3, ANC ≥ 1,500 cells/mm3, Platelets ≥ 100,000/mm3
    • Hemoglobin ≥ 10 g/dL (transfusion allowed)
    • Total bilirubin ≤ 1.5 x upper normal limit (UNL)
    • AST (SGOT), ALT (SGPT) ≤ 3.0 x UNL (≤ 5.0 x UNL may be acceptable)
    • Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance > 45 mL/min/1.73 m2
    • PT/aPTT < 1.5 x UNL or within therapeutic range via anti-coagulation therapy
  • Karnofsky PS ≥ 70%.

  • Estimated life expectancy > 3 months.

  • Signed informed consent approved IRB and ability to comply with the study or monitoring procedures.

  • Subjects with evaluable disease are eligible in dose-escalation cohorts

Exclusion criteria

  • Prior therapies for disease under study less than 4 weeks prior to enrollment.
  • Major surgery or trauma within 4 weeks of enrollment.
  • Active brain metastases
  • Active chronic inflammatory, autoimmunity, immunodeficiency disease, and vascular or hemorrhagic disorders.
  • History of allergic reactions to dolastatin, auristatin or compounds of similar composition.
  • Significant cardiovascular disease
  • Other malignancies
  • Pregnancy or breast feeding
  • Refusal or inability to use effective means of contraception (for men, and women with childbearing potential)
  • History of or test-positive to HIV, or hepatitis B or C

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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