A Phase 1b Study of MDX-1106 in Subjects With Advanced or Recurrent Malignancies

What is the purpose of this trial?

Who can participate?

Ages Eligible: 18 Years and older
Gender Eligible: Both

Inclusion Criteria:

- Subjects must have mCRPC,RCC, MEL, NSCLC, or CRC, that is advanced (non-resectable),
or recurrent and for which no alternative, curative standard exists

- ECOG Performance Status of 0-2

- Must have at least 1 measurable lesion

- Subjects with mCRPC and with only non-measurable bone lesions must have either
progression new lesions or have PSA progression within the 6-week period before study
administration

- At least 1 and up to 5 prior systemic therapies for advanced/recurrent disease

- Prior treated brain or meningeal metastases must be without MRI evidence of
progression for at least 8 weeks and off immunosuppressive doses of systemic steroids
for at least 2 weeks before study drug administration

- Prior systemic radiation therapy must have been completed at least 4 weeks before
study drug administration. Prior focal radiotherapy completed at least 2 weeks prior
to study drug administration

- Immunosuppressive doses of systemic medications, such as steroids or absorbed topical
steroids must be discontinued at least 2 weeks before study drug administration

- Prior surgery that required general anesthesia must be completed at least 2 weeks
before study drug administration. Surgery requiring local/epidural anesthesia must be
completed at least 72 hours before study drug administration

Exclusion Criteria:

- History of severe hypersensitivity reactions to other mAbs

- Subjects with any active autoimmune disease or a documented history of autoimmune
disease, or history of syndrome that required systemic steroids or immunosuppressive
medications, except for subjects with vitiligo or resolved childhood asthma/atopy

- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or
any other antibody targeting T cell co-stimulation pathways)

- Known history of Human Immunodeficiency Virus

- Active infection requiring therapy, positive tests for Hepatitis B surface antigen or
Hepatitis C ribonucleic acid (RNA)

- Underlying medical conditions that will make the administration of study drug
hazardous

- Concurrent medical condition requiring the use of immunosuppressive medications, or
immunosuppressive doses of systemic or absorbable topical corticosteroids

- Use of other investigational drugs (drugs not marketed for any indication) within 28
days or at least 5 half-lives (whichever is longer) before study drug administration

What is the purpose of this trial?

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Who can participate?

Ages Eligible: 18 Years and older
Gender Eligible: Both

Inclusion Criteria:

- Subjects must have mCRPC,RCC, MEL, NSCLC, or CRC, that is advanced (non-resectable),
or recurrent and for which no alternative, curative standard exists

- ECOG Performance Status of 0-2

- Must have at least 1 measurable lesion

- Subjects with mCRPC and with only non-measurable bone lesions must have either
progression new lesions or have PSA progression within the 6-week period before study
administration

- At least 1 and up to 5 prior systemic therapies for advanced/recurrent disease

- Prior treated brain or meningeal metastases must be without MRI evidence of
progression for at least 8 weeks and off immunosuppressive doses of systemic steroids
for at least 2 weeks before study drug administration

- Prior systemic radiation therapy must have been completed at least 4 weeks before
study drug administration. Prior focal radiotherapy completed at least 2 weeks prior
to study drug administration

- Immunosuppressive doses of systemic medications, such as steroids or absorbed topical
steroids must be discontinued at least 2 weeks before study drug administration

- Prior surgery that required general anesthesia must be completed at least 2 weeks
before study drug administration. Surgery requiring local/epidural anesthesia must be
completed at least 72 hours before study drug administration

Exclusion Criteria:

- History of severe hypersensitivity reactions to other mAbs

- Subjects with any active autoimmune disease or a documented history of autoimmune
disease, or history of syndrome that required systemic steroids or immunosuppressive
medications, except for subjects with vitiligo or resolved childhood asthma/atopy

- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or
any other antibody targeting T cell co-stimulation pathways)

- Known history of Human Immunodeficiency Virus

- Active infection requiring therapy, positive tests for Hepatitis B surface antigen or
Hepatitis C ribonucleic acid (RNA)

- Underlying medical conditions that will make the administration of study drug
hazardous

- Concurrent medical condition requiring the use of immunosuppressive medications, or
immunosuppressive doses of systemic or absorbable topical corticosteroids

- Use of other investigational drugs (drugs not marketed for any indication) within 28
days or at least 5 half-lives (whichever is longer) before study drug administration

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Additional Locations

North Carolina