AdenocarcinomaPhase 1NCT00051675
Phase I Study of a Monoclonal Antibody for Treatment of Advanced Adenocarcinomas
A Phase 1 study testing ING-1(heMAb) in people with Adenocarcinoma, run by XOMA (US) LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, immunogenicity, and tolerability of a monoclonal antibody administered subcutaneously in the treatment of advanced cancers of the ovary, breast, lung, prostate, colon or rectum that are either refractory to standard therapies or for which therapies that may… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma
- What is being tested?
- ING-1(heMAb)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Sep 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has adenocarcinomas of the ovary, breast, lung, prostate, colon or rectum.
- 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.
- Subject has measurable lesions. Subjects with prostate cancer can have non-measurable lesions.
- 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.
- 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.
- 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.
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- Subject has a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Subject has an estimated life expectancy of at least 12 weeks.
- Subject is at least 18 years of age.
- 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)
- Signed informed consent form.
- Male and female subjects with reproductive potential must use an approved contraceptive method.
- Female subjects with reproductive potential must have a negative serum pregnancy test within seven days of study enrollment.
Who cannot join
- Subject has serious concomitant systemic disorders incompatible with the study.
- Subject has used any other investigational agent within 30 days of study entry.
- Subject is pregnant or lactating.
- Subject has undergone a bone marrow transplant.
- 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).
- 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.)
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- 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.
- Subject has an active auto-immune disease requiring chronic treatment.
- Subject is using or has used immunosuppressive drugs such as cyclosporine, ACTH or corticosteroids within four weeks prior to enrollment.
- Subject has brain metastases or a known history of brain metastases.
- Subject has a history of alcoholism or chronic pancreatitis or a family history of acute or chronic pancreatitis.
- Subject has hypertriglyceridemia ( Serum triglycerides 500 mg/dL).
- Subject has a history of gall bladder disease or gallstones (post-cholecystectomy subjects are allowed).
Trial locations and contacts
1 site in 1 country.
United States1 site
Jack D. Weiler Hospital of the Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: 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
The purpose of this study is to evaluate the safety, immunogenicity, and tolerability of a monoclonal antibody administered subcutaneously in the treatment of advanced cancers of the ovary, breast, lung, prostate, colon or rectum that are either refractory to standard therapies or for which therapies that may potentially be of major benefit do not exist.
- Conditions
- Adenocarcinoma
- Being tested
- ING-1(heMAb)
- Keywords
- adenocarcinoma, monoclonal antibody
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ING-1(heMAb)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2003 (estimated)
- Study startJul 2002
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- XOMA (US) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051675
- Sponsor's protocol ID
- INCA104
- Status last verified
- Sep 2004
- First submitted
- 14 Jan 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00051675
- Acronym / sponsor ID
- INCA104
- Conditions
- Adenocarcinoma
- Keywords
- adenocarcinoma, monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Study completion
- Sep 2003
- First posted
- 16 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, immunogenicity, and tolerability of a monoclonal antibody administered subcutaneously in the treatment of advanced cancers of the ovary, breast, lung, prostate, colon or rectum that are either refractory to standard therapies or for which therapies that may potentially be of major benefit do not exist.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Subject has adenocarcinomas of the ovary, breast, lung, prostate, colon or rectum.
- 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.
- Subject has measurable lesions. Subjects with prostate cancer can have non-measurable lesions.
- 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.
- 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.
Key exclusion criteria (13 listed)
- Subject has serious concomitant systemic disorders incompatible with the study.
- Subject has used any other investigational agent within 30 days of study entry.
- Subject is pregnant or lactating.
- Subject has undergone a bone marrow transplant.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ING-1(heMAb) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ING-1(heMAb) in people with Adenocarcinoma, run by XOMA (US) LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.