Gastric CancerPhase 1NCT02908451
A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer
A Phase 1 study testing AbGn-107 in people with Gastric Cancer and Colorectal Cancer, run by AbGenomics B.V Taiwan Branch at 9 sites in 2 countries.
Trial summary
This study is to define the safety profile and to determine the Maximal tolerated dose regimen and preliminary efficacy of AbGn-107 administered every 14 days (Q2W regimen) or 28 days (Q4W regimen) in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal, pancreatic or biliary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Colorectal Cancer, Pancreatic Cancer
- What is being tested?
- AbGn-107
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 24 Apr 2017to 28 Feb 2021
- 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
- Age ≥18 years. A patient may be of either sex and of any race/ethnicity.
- Histologically confirmed, chemo-refractory, locally advanced, recurrent or metastatic gastric (including GE junction), colorectal, or pancreatic adenocarcinoma or biliary cancer (including cholangiocarcinoma, gallbladder and ampullary carcinomas).
- Patient must not have curative options available (e.g. a single metastatic focus in the liver in a patient with MCRC eligible for metastasectomy).
- Chemo-refractory is defined as:
- Progression on or following, or intolerant of, at least one prior line of standard systemic therapy for advanced or metastatic gastric or pancreatic or biliary cancers.
- Progression on or following, or intolerant of, at least two prior lines of standard systemic therapy for advanced or metastatic colorectal cancers.
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- Patients who have progressed/recurred following neoadjuvant/adjuvant chemotherapy for earlier stage disease, if completed within the previous 6 months, are eligible.
- Archived tissue must be available for all patients (both dose escalation and expansion cohorts). Dose Escalation Only-If tissue is not available, patients may still be considered eligible for enrollment, if all other eligibility criteria are confirmed and after discussion with and approval by the sponsor medical monitor. Cohort Expansion Only-Tissue must be to confirmed high expression of AG7 antigen during the Pre-Screening period, defined as immune reactive score (IRS) ≥8, via slides from original diagnostic biopsy material or biopsy of recurrent/metastatic disease, prior to enrollment.
- Measurable disease by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
- Adequate organ function within 3 weeks prior to first study drug administration as evidenced by:
- Absolute neutrophil count ≥1.5 x 10^9/L,
- Hemoglobin ≥9 g/dL,
- Platelet count ≥100 x 10^9/L,
- Serum creatinine ≤1.5 x upper limit of normal (ULN) or a calculated creatinine clearance >60 mL/min,
- Total bilirubin <1.5 x ULN, except for patients with Gilbert's disease who are eligible if total bilirubin ≤ 3 mg/dL.
- Aspartate aminotransferase (AST)/serum glutamic-oxalacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) <2.5 x ULN, or, in the presence of documented liver metastases, ≤5 x ULN.
- Ability to adhere to dose and visit schedules.
- Women of childbearing potential (WOCP) must have a negative pregnancy test result prior to enrollment. WOCP and men whose partners are WOCP must agree to use a highly effective method of birth control during the study and for 6 months following the last dose of study drug. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).
- Ability to provide written informed consent
- Life expectancy of at least 3 months.
Who cannot join
- Any persistent, unresolved Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 drug-related toxicity (except alopecia, erectile impotence, tinnitus, hot flashes, and loss of libido) associated with previous treatment. Inclusion of patients with persistent neuropathy or hearing loss Grade ≥2 due to previous treatment requires discussion with the sponsor.
- Radiation therapy within 2 weeks prior to first study drug administration.
- Major surgery within 3 weeks prior to first study drug administration.
- Any chemotherapy within 30 days of enrollment.
- Participation in any other clinical study with a potentially therapeutic agent or receipt of another investigational product within 21 days or 5 plasma half-lives, whichever is longer, prior to first day of drug administration (Day 1).
- Active central nervous system metastases. Patients with a history of brain metastases may be eligible, provided they have been definitively treated and are clinically stable, after discussion with sponsor. Treated or untreated leptomeningeal disease is not permitted.
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- Known human immunodeficiency virus (HIV) infection or a known HIV-related malignancy. Note: HIV testing is not required unless there is any clinical suspicion that the patient might be HIV positive.
- Known active hepatitis B or C. HBV and HCV tests are required prior to Day 1.
- Any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would impair with their ability to receive or tolerate the planned treatment, or interfere with the study evaluations or optimal participation in the study.
- Pregnancy or breastfeeding.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Mayo Clinic
Phoenix, Arizona, 85054
University of California
San Francisco, California, 94143
University of Washington, Seattle Cancer Care Alliance
Seattle, Washington, 98109
Taiwan3 sites
China Medical University Hospital
Taichung, 404
National Cheng Kung University Hospital
Tainan, 48
National Taiwan University Hospital
Taipei, 100
About this study
Official title: A Phase I Dose Escalation Study, With Cohort Expansion, to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AbGn-107 Therapy in Patients With Chemo-refractory Locally Advanced, Recurrent, or Metastatic Gastric, Colorectal, Pancreatic or Biliary Cancer
This study is to define the safety profile and to determine the Maximal tolerated dose regimen and preliminary efficacy of AbGn-107 administered every 14 days (Q2W regimen) or 28 days (Q4W regimen) in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal, pancreatic or biliary cancer.
Read the detailed description
AbGn-107 is an antibody drug conjugate (ADC) which targets an antigen (AG7 antigen) present in gastric, colorectal, pancreatic cancer or biliary cancer. This study is a standard 3 + 3 dose escalation design with cohort expansion. AbGn-107 will be administered every 14 days (Q2W regimen) or 28 days (Q4W regimen) in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal, pancreatic adenocarcinoma or biliary cancer. The primary objectives of this study are to define the safety profile and to determine the maximum tolerated dose regimen of AbGn-107, and the secondary objectives are to evaluate the pharmacokinetic (PK) parameters, the immunogenicity, and preliminary efficacy of AbGn-107.
- Conditions
- Gastric Cancer, Colorectal Cancer, Pancreatic Cancer, Biliary Cancer
- Being tested
- AbGn-107
- Keywords
- Cancer, Antibody Drug Conjugate, AbGn-107, Adenocarcinoma, Gastric, Colorectal, Pancreatic, biliary, cholangiocarcinoma, gallbladder, ampullary carcinomas
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Biliary Tract Neoplasms, Neoplasms, Adenocarcinoma, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbGn-107Biological
Antibody Drug Conjugate
| Study group | Role | What they receive |
|---|---|---|
| AbGn-107 | Experimental | AbGn-107 will be administered every 14-days or 28-days via intravenous infusion. Patients with a complete response (CR), partial response (PR), or stable disease (SD), or with evidence of clinical benefit may be treated every continuously every 14-days or 28-days.. Receives: Biological: AbGn-107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs) graded according to CTCAE v4.03.
Measured: 28 days
Secondary outcomes (5)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: 70 days after treatment
Tmax (time from dosing to maximum measured concentration)
Measured: 70 days after treatment
T1/2 (half-life of the analyte)
Measured: 70 days after treatment
Immunogenicity evaluation based on anti-drug antibodies titer
Measured: 70 days after treatment
Overall Response Rate Evaluated by Response Evaluation Criteria in Solid Tumor (RECIST)
Measured: Every 2 treatment cycles for Q4W regimen or every 4 treatment cycles for Q2W regimen, up to 2 years from the first patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start24 Apr 2017
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Why it stopped: COVID-19 pandemic has caused a huge operational difficulty for this ongoing clinical trial, as many hospitals have set limitations on onsite staff, patient visits, study related procedures and onsite monitoring visits.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbGenomics B.V Taiwan Branch
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shih-Yao (David) Lin, MD, PhD, Study director, AbGenomics B.V.Andrew Ko, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908451
- Sponsor's protocol ID
- 2016.006.01
- Status last verified
- Jul 2020
- First submitted
- 6 Sep 2016
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ko AH, Coveler AL, Schlechter BL, Bekaii-Saab T, Wolpin BM, Clark JW, Bockorny B, Bai LY, Lin YC, Chiang E, Langecker P, Lin SY. A multicenter phase Ia study of AbGn-107, a novel antibody-drug conjugate, in patients with advanced gastrointestinal cancer. Invest New Drugs. 2024 Apr;42(2):221-228. doi: 10.1007/s10637-024-01430-6. Epub 2024 Mar 5.
PubMed 38441850
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study, With Cohort Expansion, to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AbGn-107 Therapy in Patients With Chemo-refractory Locally Advanced, Recurrent, or Metastatic Gastric, Colorectal, Pancreatic or Biliary Cancer
- ClinicalTrials.gov ID
- NCT02908451
- Acronym / sponsor ID
- 2016.006.01
- Conditions
- Gastric Cancer, Colorectal Cancer, Pancreatic Cancer, Biliary Cancer
- Keywords
- Cancer, Antibody Drug Conjugate, AbGn-107, Adenocarcinoma, Gastric, Colorectal, Pancreatic, biliary
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic has caused a huge operational difficulty for this ongoing clinical trial, as many hospitals have set limitations on onsite staff, patient visits, study related procedures and onsite monitoring visits.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- AbGenomics B.V Taiwan BranchIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 21 Sep 2016 (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.
This study is to define the safety profile and to determine the Maximal tolerated dose regimen and preliminary efficacy of AbGn-107 administered every 14 days (Q2W regimen) or 28 days (Q4W regimen) in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal, pancreatic or biliary cancer.
Detailed description
AbGn-107 is an antibody drug conjugate (ADC) which targets an antigen (AG7 antigen) present in gastric, colorectal, pancreatic cancer or biliary cancer. This study is a standard 3 + 3 dose escalation design with cohort expansion. AbGn-107 will be administered every 14 days (Q2W regimen) or 28 days (Q4W regimen) in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal, pancreatic adenocarcinoma or biliary cancer. The primary objectives of this study are to define the safety profile and to determine the maximum tolerated dose regimen of AbGn-107, and the secondary objectives are to evaluate the pharmacokinetic (PK) parameters, the immunogenicity, and preliminary efficacy of AbGn-107.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AbGn-107 | Experimental | Biological: AbGn-107AbGn-107 will be administered every 14-days or 28-days via intravenous infusion. Patients with a complete response (CR), partial response (PR), or stable disease (SD), or with evidence of clinical benefit may be treated every continuously every 14-days or 28-days.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age ≥18 years. A patient may be of either sex and of any race/ethnicity.
- Histologically confirmed, chemo-refractory, locally advanced, recurrent or metastatic gastric (including GE junction), colorectal, or pancreatic adenocarcinoma or biliary cancer (including cholangiocarcinoma, gallbladder and ampullary carcinomas).
- Archived tissue must be available for all patients (both dose escalation and expansion cohorts). Dose Escalation Only-If tissue is not available, patients may still be considered eligible for enrollment, if all other eligibility criteria are confirmed and after discussion with and approval by the sponsor medical monitor. Cohort Expansion Only-Tissue must be to confirmed high expression of AG7 antigen during the Pre-Screening period, defined as immune reactive score (IRS) ≥8, via slides from original diagnostic biopsy material or biopsy of recurrent/metastatic disease, prior to enrollment.
- Measurable disease by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
Key exclusion criteria (10 listed)
- Any persistent, unresolved Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 drug-related toxicity (except alopecia, erectile impotence, tinnitus, hot flashes, and loss of libido) associated with previous treatment. Inclusion of patients with persistent neuropathy or hearing loss Grade ≥2 due to previous treatment requires discussion with the sponsor.
- Radiation therapy within 2 weeks prior to first study drug administration.
- Major surgery within 3 weeks prior to first study drug administration.
- Any chemotherapy within 30 days of enrollment.
- Participation in any other clinical study with a potentially therapeutic agent or receipt of another investigational product within 21 days or 5 plasma half-lives, whichever is longer, prior to first day of drug administration (Day 1).
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-107Antibody Drug Conjugate | Biological | AbGn-107 |
Primary outcome
Adverse events (AEs) graded according to CTCAE v4.03.
Time frame: 28 days
5 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: 70 days after treatment
Tmax (time from dosing to maximum measured concentration)
Time frame: 70 days after treatment
T1/2 (half-life of the analyte)
Time frame: 70 days after treatment
Immunogenicity evaluation based on anti-drug antibodies titer
Time frame: 70 days after treatment
Overall Response Rate Evaluated by Response Evaluation Criteria in Solid Tumor (RECIST)
Time frame: Every 2 treatment cycles for Q4W regimen or every 4 treatment cycles for Q2W regimen, up to 2 years from the first patient enrolled
Results and safety
The study was stopped early (reason given: COVID-19 pandemic has caused a huge operational difficulty for this ongoing clinical trial, as many hospitals have set limitations on onsite staff, patient visits, study related procedures and onsite monitoring visits.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Derived from this study: PubMed 38441850Ko AH, Coveler AL, Schlechter BL, Bekaii-Saab T, Wolpin BM, Clark JW, Bockorny B, Bai LY, Lin YC, Chiang E, Langecker P, Lin SY. A multicenter phase Ia study of AbGn-107, a novel antibody-drug conjugate, in patients with advanced gastrointestinal cancer. Invest New Drugs. 2024 Apr;42(2):221-228. doi: 10.1007/s10637-024-01430-6. Epub 2024 Mar 5.
- Individual participant dataSharing planned: No
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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 (David) Lin, MD, PhD study director
AbGenomics B.V.
Andrew Ko, MD principal investigator
University of California, San Francisco
9 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-107 in people with Gastric Cancer and Colorectal Cancer, run by AbGenomics B.V Taiwan Branch at 9 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 21 inclusion and 10 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: stopped early, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 was stopped early (reason given: COVID-19 pandemic has caused a huge operational difficulty for this ongoing clinical trial, as many hospitals have set limitations on onsite staff, patient visits, study related procedures and onsite monitoring visits.). Results are not available in the source record.
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?
Adverse events (AEs) graded according to CTCAE v4.03. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02908451, which also lists 1 linked publication.
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 13 Jul 2021.