Solid Tumor of Epithelial OriginPhase 1NCT01466569
An A/B Dose Escalation Study of AbGn-7 Alone and With FOLFOX7 Treatment in Patients With Advanced Solid Tumors
A Phase 1 study testing AbGn-7 in people with Solid Tumor of Epithelial Origin and Gastric Cancer, run by AbGenomics B.V Taiwan Branch at 4 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety and tolerability profile including the dose limiting toxicity of AbGn-7 in patients with chemo-refractory advanced solid tumor of epithelial origin, and of AbGn-7 in combination with FOLFOX7 in patients with chemo-naive/chemo-refractory recurrent, locally advanced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor of Epithelial Origin, Gastric Cancer
- What is being tested?
- AbGn-7
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2011to Jan 2013
- 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
- must provide written informed consent.
- must be ≥18 years of age, either sex and of any race/ethnicity.
- Phase 1a: must have a histologically or cytologically confirmed advanced malignant solid tumor of epithelial origin and must have failed on previous chemotherapy. Phase 1b: must have a histologically or cytologically confirmed, recurrent, locally advanced or metastatic gastric cancer with measurable disease; must be chemo-naïve or must have failed on previous chemotherapy; must not have received an oxaliplatin-based chemotherapeutic regimen or monoclonal antibody therapy.
- must have an Eastern Cooperative Oncology Group Performance Status of ≤2.
- must have adequate hematological, renal and liver functions within 3 weeks prior to first study drug administration as evidenced by: a) Absolute neutrophil count ≥1.5 x 109/L, b) Hemoglobin ≥90 g/L (≥80 g/L for patients with documented renal cell carcinoma), c) Platelet count ≥100 x 109/L, d) Serum creatinine ≤1.5 x upper limit of normal ULN or a calculated creatinine clearance ≥60 mL/minute, e) Total bilirubin <1.5 x ULN, except for patients with documented Gilbert's disease, f) AST/SGOT and ALT/SGPT < 2.5 x ULN, or, in the presence of documented liver metastases, ≤5 x ULN.
- must be able to adhere to dose and visit schedules.
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- Each female patient of childbearing potential must agree to use a medically accepted method of contraception or to abstain from sexual intercourse and each male patient must agree to use a medically accepted method of contraception or to abstain from sexual intercourse during the study and for 60 days after stopping the study drug.
- A life expectancy of at least 3 months.
- Available tumor tissue in the form of unstained slides for determination of AbGn-7 epitope expression (optional for Phase 1a, obligatory for Phase 1b). Patients without archival/banked tumor tissue obtained at the time of initial diagnosis must have a biopsy performed according to institutional guidelines prior to the initiation of treatment.
Who cannot join
- No current treated or untreated leptomeningeal metastasis or a metastatic CNS lesion.
- For Phase 1a, patients should not have received chemotherapy within 30 days prior to initiation of AbGn-7 therapy. For Phase 1b, patients should not have received oxaliplatin-based chemotherapy or monoclonal antibody therapy for their gastric cancer prior to enrollment.
- Have note received radiation therapy within 3 weeks prior to first study drug administration and must have adequately recovered from any associated toxicity and/or complications of this intervention.
- Have not undergone major surgery within 3 weeks prior to the first study drug administration and must have adequately recovered from the toxicity and/or complications of these interventions.
- No current human immunodeficiency virus (HIV) infection or a current HIV-related malignancy.
- No current active hepatitis B or C.
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- No any serious or uncontrolled infection.
- No uncontrolled diabetes mellitus, defined as a HbA1c of ≥7.5% in a patient with documented diabetes mellitus.
- No any of the following within 6 months prior to first study drug administration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident or transient ischemic attack, or seizure disorder.
- No persistent, unresolved NCI CTCAE Grade ≥2 drug-related toxicity associated with previous chemotherapy.
- Not participating in any other clinical study with a potentially therapeutic agent, or have not received another investigational product within 21 days.
- No any clinically significant condition or situation which would interfere with the study evaluations or optimal participation in the study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Fox Chase Cancer Center
Rockledge, Pennsylvania, 19046
The University of Texas Health Science Center-CTRC
San Antonio, Texas, 78229
Taiwan2 sites
MacKay Memorial Hospital
Taipei, 104
National Taiwan University Hospital
Taipei, 104
About this study
Official title: A Phase 1 A/B Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AbGn-7 Therapy Alone and in Combination With the FOLFOX7 Treatment Regimen in Patients With Advanced Solid Tumors
The purpose of this study is to determine the safety and tolerability profile including the dose limiting toxicity of AbGn-7 in patients with chemo-refractory advanced solid tumor of epithelial origin, and of AbGn-7 in combination with FOLFOX7 in patients with chemo-naive/chemo-refractory recurrent, locally advanced or metastatic gastric cancer.
Read the detailed description
Monoclonal antibodies, alone or in combination with chemotherapeutic agents, have been proven to be effective treatment for many malignant diseases in human. Antibodies can mediate cytotoxicity through complement dependent cytotoxicty (CDC), antibody dependent cell mediated cytotoxicity (ADCC) or apoptosis.
AbGn-7 was identified based on its direct killing (apoptosis-inducing) activities towards cancer cells expressing its epitope. In vitro data also demonstrated its ability to elicit CDC and ADCC. The in vivo xenograft study of AbGn-7 demonstrated that AbGn-7 alone or in combination with chemotherapeutic agents successfully suppressed the growth of gastric, pancreatic, and colorectal tumours. The NHP study proved the safety profile of AbGn-7. The present Phase 1 clinical study is designed to evaluate the safety and tolerability of AbGn-7 alone in patients with solid tumors of epithelial origin (Phase 1a) and in combination with a current chemotherapeutic regimen FOLFOX7 in patients with recurrent, locally advanced or metastatic gastric carcinoma (Phase 1b).
- Conditions
- Solid Tumor of Epithelial Origin, Gastric Cancer
- Being tested
- AbGn-7
- Keywords
- Advanced Solid Tumor, Gastric Cancer, Oncology, monoclonal Antibody
- Medical subject headings
- Stomach Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbGn-7Drug
Phase 1a: dose escalation; Drug: AbGn-7 weekly iv infusion Duration: 6 weeks
AbGn-7Drug
Phase 1b: two doses (one dose below MTD/MAD and MTD/MAD as determined in phase 1a) Drug: AbGn-7 weekly iv infusion combined with FOLFOX7 Duration: 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| AbGn-7 phase 1a cohort 1 | Experimental | Not described Receives: Drug: AbGn-7 |
| AbGn-7 phase 1a cohort 2 | Experimental | Not described Receives: Drug: AbGn-7 |
| AbGn-7 phase 1a cohort 3 | Experimental | Not described Receives: Drug: AbGn-7 |
| AbGn-7 phase 1b cohort 1 | Experimental | Not described Receives: Drug: AbGn-7 |
| AbGn-7 phase 1b cohort 2 | Experimental | Not described Receives: Drug: AbGn-7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be assessed by analysis of adverse event, clinical laboratory tests and physical examination
Measured: 10 Weeks
Secondary outcomes (3)
Pharmacokinetics will be assessed at 3 different dose levels in phase 1a and at 2 dose levels in phase 1b
Measured: 12 Weeks
Serum anti-drug antibodies will be assessed at 3 different dose levels in phase 1a and at 2 dose levels in phase 1b
Measured: 12 weeks
Tumor response rate by Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor of Epithelial OriginStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbGenomics B.V Taiwan Branch
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shih-Yao Lin, MD, PhD, Study director, AbGenomics B.V Taiwan BranchDevalingham Mahalingam, MD, Principal investigator, The University of Texas Health Science Center-CTRCAnthony Olaszanski, MD, RPh, Principal investigator, Fox Chase Cancer CenterKuen-Hui Yeh, MD, Principal investigator, National Taiwan University HospitalRuey-Kuen Hsieh, MD, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466569
- Sponsor's protocol ID
- AbGenomics-2010.007.01
- Status last verified
- Jun 2015
- First submitted
- 2 Nov 2011
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 A/B Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AbGn-7 Therapy Alone and in Combination With the FOLFOX7 Treatment Regimen in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01466569
- Acronym / sponsor ID
- AbGenomics-2010.007.01
- Conditions
- Solid Tumor of Epithelial Origin, Gastric Cancer
- Keywords
- Advanced Solid Tumor, Gastric Cancer, Oncology, monoclonal Antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- AbGenomics B.V Taiwan BranchIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Nov 2011 (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 determine the safety and tolerability profile including the dose limiting toxicity of AbGn-7 in patients with chemo-refractory advanced solid tumor of epithelial origin, and of AbGn-7 in combination with FOLFOX7 in patients with chemo-naive/chemo-refractory recurrent, locally advanced or metastatic gastric cancer.
Detailed description
Monoclonal antibodies, alone or in combination with chemotherapeutic agents, have been proven to be effective treatment for many malignant diseases in human. Antibodies can mediate cytotoxicity through complement dependent cytotoxicty (CDC), antibody dependent cell mediated cytotoxicity (ADCC) or apoptosis.
AbGn-7 was identified based on its direct killing (apoptosis-inducing) activities towards cancer cells expressing its epitope. In vitro data also demonstrated its ability to elicit CDC and ADCC. The in vivo xenograft study of AbGn-7 demonstrated that AbGn-7 alone or in combination with chemotherapeutic agents successfully suppressed the growth of gastric, pancreatic, and colorectal tumours. The NHP study proved the safety profile of AbGn-7. The present Phase 1 clinical study is designed to evaluate the safety and tolerability of AbGn-7 alone in patients with solid tumors of epithelial origin (Phase 1a) and in combination with a current chemotherapeutic regimen FOLFOX7 in patients with recurrent, locally advanced or metastatic gastric carcinoma (Phase 1b).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AbGn-7 phase 1a cohort 1 | Experimental | Drug: AbGn-7 |
| AbGn-7 phase 1a cohort 2 | Experimental | Drug: AbGn-7 |
| AbGn-7 phase 1a cohort 3 | Experimental | Drug: AbGn-7 |
| AbGn-7 phase 1b cohort 1 | Experimental | Drug: AbGn-7 |
| AbGn-7 phase 1b cohort 2 | Experimental | Drug: AbGn-7 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- must provide written informed consent.
- must be ≥18 years of age, either sex and of any race/ethnicity.
- Phase 1a: must have a histologically or cytologically confirmed advanced malignant solid tumor of epithelial origin and must have failed on previous chemotherapy. Phase 1b: must have a histologically or cytologically confirmed, recurrent, locally advanced or metastatic gastric cancer with measurable disease; must be chemo-naïve or must have failed on previous chemotherapy; must not have received an oxaliplatin-based chemotherapeutic regimen or monoclonal antibody therapy.
- must have an Eastern Cooperative Oncology Group Performance Status of ≤2.
- must have adequate hematological, renal and liver functions within 3 weeks prior to first study drug administration as evidenced by: a) Absolute neutrophil count ≥1.5 x 109/L, b) Hemoglobin ≥90 g/L (≥80 g/L for patients with documented renal cell carcinoma), c) Platelet count ≥100 x 109/L, d) Serum creatinine ≤1.5 x upper limit of normal ULN or a calculated creatinine clearance ≥60 mL/minute, e) Total bilirubin <1.5 x ULN, except for patients with documented Gilbert's disease, f) AST/SGOT and ALT/SGPT < 2.5 x ULN, or, in the presence of documented liver metastases, ≤5 x ULN.
Key exclusion criteria (12 listed)
- No current treated or untreated leptomeningeal metastasis or a metastatic CNS lesion.
- For Phase 1a, patients should not have received chemotherapy within 30 days prior to initiation of AbGn-7 therapy. For Phase 1b, patients should not have received oxaliplatin-based chemotherapy or monoclonal antibody therapy for their gastric cancer prior to enrollment.
- Have note received radiation therapy within 3 weeks prior to first study drug administration and must have adequately recovered from any associated toxicity and/or complications of this intervention.
- Have not undergone major surgery within 3 weeks prior to the first study drug administration and must have adequately recovered from the toxicity and/or complications of these interventions.
- No current human immunodeficiency virus (HIV) infection or a current HIV-related malignancy.
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 |
|---|---|---|
| AbGn-7Phase 1a: dose escalation; Drug: AbGn-7 weekly iv infusion Duration: 6 weeks | Drug | AbGn-7 phase 1a cohort 1, AbGn-7 phase 1a cohort 2, AbGn-7 phase 1a cohort 3 |
| AbGn-7Phase 1b: two doses (one dose below MTD/MAD and MTD/MAD as determined in phase 1a) Drug: AbGn-7 weekly iv infusion combined with FOLFOX7 Duration: 6 weeks | Drug | AbGn-7 phase 1b cohort 1, AbGn-7 phase 1b cohort 2 |
Primary outcome
Safety will be assessed by analysis of adverse event, clinical laboratory tests and physical examination
Time frame: 10 Weeks
3 secondary outcomes
Pharmacokinetics will be assessed at 3 different dose levels in phase 1a and at 2 dose levels in phase 1b
Time frame: 12 Weeks
Serum anti-drug antibodies will be assessed at 3 different dose levels in phase 1a and at 2 dose levels in phase 1b
Time frame: 12 weeks
Tumor response rate by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 10 weeks
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 23 Jun 2015.
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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.
Shih-Yao Lin, MD, PhD study director
AbGenomics B.V Taiwan Branch
Devalingham Mahalingam, MD principal investigator
The University of Texas Health Science Center-CTRC
Anthony Olaszanski, MD, RPh principal investigator
Fox Chase Cancer Center
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AbGn-7 in people with Solid Tumor of Epithelial Origin and Gastric Cancer, run by AbGenomics B.V Taiwan Branch at 4 sites in 2 countries.
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 9 inclusion and 12 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 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Taiwan. 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.
What does the primary outcome measure?
Safety will be assessed by analysis of adverse event, clinical laboratory tests and physical examination (time frame: 10 Weeks). It is what the study was designed to measure, not a finding.
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 23 Jun 2015.