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 range18 Years – 99 Years
SexALL
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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).
✓. 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.
✕
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.
. 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.