A Phase 1b/2 Clinical Trial Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynami… (NCT07040059) | Clinical Trial Compass
TerminatedPhase 1/2
A Phase 1b/2 Clinical Trial Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AUR103 Calcium in Patients With HER2-positive Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Stopped: Patient recruitment problems.
India2 participantsStarted 2025-03-22
Plain-language summary
The study will have a dose escalation part (Phase 1b) and a randomized part (Phase 2). In Phase 1b, patients diagnosed with advanced HER2 positive gastric/gastroesophageal adenocarcinoma will be enrolled in a 3 + 3 design dose escalation manner to evaluate the safety, efficacy, PK/PD of AUR103 Calcium when administered in combination with Trastuzumab and CAPOX (capecitabine and oxaliplatin). Phase 2 is a randomization study. The primary objective of the phase 2 study is to assess the efficacy of AUR103 Calcium when administered in combination with Trastuzumab and CAPOX (capecitabine and oxaliplatin). The phase 2 of the study will be conducted after Phase 1b.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provide signed and dated informed consent and agree to comply with all study related activities.
. Male or female patients aged greater than or equal to 18 years.
. Patients must meet the following criteria for each of the respective parts of the study:
. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
. Acceptable bone marrow as described below:
. ANC greater than or equal to 1500/μL (without WBC growth factor support).
. Platelet count greater than or equal to 100,000/μL (without transfusion support).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1 (Safety): Treatment Emergent Adverse Events (TEAEs)
Timeframe: Through the study completion, an average of 1 year
2
Part 1 (Pharmacokinetics): Area under the curve (AUC)
Timeframe: On Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent cycle through study completion, for an average duration of one year.
3
Part 1 (Pharmacokinetics): Maximum concentration
Timeframe: On Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent cycle through study completion, for an average duration of one year.
4
Part 1 (Pharmacokinetics): Time to Maximum concentration
Timeframe: On Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent cycle through study completion, for an average duration of one year.
5
Part 1 (Pharmacokinetics): Terminal elimination half life
Timeframe: On Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent cycle through study completion, for an average duration of one year.
6
Part 2 (Efficacy): Best Objective Tumor Response Rate (ORR)
Timeframe: Every 3 cycle, through study completion, for an average duration of one year.
. Hemoglobin greater than or equal to 9 g/dL (Transfusion is allowed to achieve this Hb).
Exclusion criteria
. Patients with resectable gastric / gastroesophageal (GE) junction adenocarcinoma.
. Exposed to definitive radiotherapy \[Note: Palliative radiotherapy is allowed\].
. Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
. Known central nervous system (CNS) metastases.
. Major surgery less than or equal to 28 days from Cycle 1 Day 1 (Major surgery is defined as a procedure requiring general anaesthesia).
. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.
. Known active or chronic hepatitis B or hepatitis C infection.
. Uncontrolled congestive heart failure (New York Heart Association \[NYHA\] Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3 months prior to Cycle 1 Day 1.