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An Open-Label, Multi-Dose, Phase I, Dose-Escalating Study of a Subcutaneously Administered Human-Engineered Monoclonal Antibody, ING-1(heMAb), in Subjects With Advanced Adenocarcinomas


Phase 1
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma

Thank you

Trial Information

An Open-Label, Multi-Dose, Phase I, Dose-Escalating Study of a Subcutaneously Administered Human-Engineered Monoclonal Antibody, ING-1(heMAb), in Subjects With Advanced Adenocarcinomas

Inclusion Criteria


Inclusion Criteria

1. Subject has adenocarcinomas of the ovary, breast, lung, prostate, colon or rectum.

2. Subject has an advanced metastatic adenocarcinoma that is either refractory to
standard therapies or for which therapies that may potentially be of major benefit do
not exist.

3. Subject has measurable lesions. Subjects with prostate cancer can have non-measurable
lesions.

4. Subject may have prior radiation therapy if completed at least four weeks prior to
study entry, the subject has recovered from the acute toxicities of that therapy, and
measurable lesions are in a non-irradiated area.

5. Subject may have prior chemotherapy, cytokine therapy or immunotherapy if completed
at least four weeks prior to study entry and the subject has recovered from the acute
toxicities of that therapy.

6. Subjects with tumors responsive to hormone therapy may have prior hormonal therapy if
completed at least four weeks prior to study entry. Hormonal therapy for prostate
cancer may be continued but must not have been changed less than four weeks prior to
study entry.

7. Subject has a performance status of 0 to 2 on the Eastern Cooperative Oncology Group
(ECOG) scale.

8. Subject has an estimated life expectancy of at least 12 weeks.

9. Subject is at least 18 years of age.

10. Subject has adequate organ function defined as follows:

- Hematologic:

- Platelets 100 × 109/L

- Hemoglobin 9.0 g/dL

- Total WBC count 3.5 × 109/L

- PT/INR and PTT are within institutional limits in subjects who are not
receiving therapeutic anticoagulation or low dose anticoagulants to
maintain venous catheter patency (subjects on anti-coagulant therapy are
allowed).

- Hepatic:

- Bilirubin 2.0 mg/dL

- Aspartate transaminase (AST) and alanine transaminase (ALT) 3 times the
upper limit of normal (AST and ALT 5 times the upper limit of normal is
acceptable if liver has tumor involvement and the elevation is due to tumor
involvement)

- Renal: Serum creatinine 1.5 mg/dL

- Pancreatic: Amylase and lipase upper limit of the normal (ULN)

11. Signed informed consent form.

12. Male and female subjects with reproductive potential must use an approved
contraceptive method.

13. Female subjects with reproductive potential must have a negative serum pregnancy test
within seven days of study enrollment.

Exclusion Criteria

1. Subject has serious concomitant systemic disorders incompatible with the study.

2. Subject has used any other investigational agent within 30 days of study entry.

3. Subject is pregnant or lactating.

4. Subject has undergone a bone marrow transplant.

5. Subject is known to be HIV+ or to have any other recognized immunodeficiency disease.
(Note: As the mechanism of action of ING-1(heMAb) is ADCC, subjects need to be
immunocompetent).

6. Subject has a history of severe allergic or anaphylactic reactions to monoclonal
antibodies or antibody fragments. (Note: For subjects who have received prior
ING-1(heMAb), the HAHA titer should be negative.)

7. Subject has concurrent or prior malignancy, except for adequately-treated basal cell
or squamous cell skin cancer, adequately-treated non-invasive carcinomas or other
cancer from which the subject has been disease-free for at least two years.

8. Subject has an active auto-immune disease requiring chronic treatment.

9. Subject is using or has used immunosuppressive drugs such as cyclosporine, ACTH or
corticosteroids within four weeks prior to enrollment.

10. Subject has brain metastases or a known history of brain metastases.

11. Subject has a history of alcoholism or chronic pancreatitis or a family history of
acute or chronic pancreatitis.

12. Subject has hypertriglyceridemia ( Serum triglycerides 500 mg/dL).

13. Subject has a history of gall bladder disease or gallstones (post-cholecystectomy
subjects are allowed).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

INCA104

NCT ID:

NCT00051675

Start Date:

July 2002

Completion Date:

September 2003

Related Keywords:

  • Adenocarcinoma
  • adenocarcinoma
  • monoclonal antibody
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

Name

Location

Jack D. Weiler Hospital of the Albert Einstein College of MedicineBronx, New York  10461