Trial Title:
A Phase 1 Clinical Trial of AUR106 in Patients With Relapsed Advanced Malignancies
NCT ID:
NCT05861947
Condition:
Relapse
Advanced Malignant Neoplasm
Non Small Cell Lung Cancer
Gastric Cancer
Urothelial Carcinoma
Kidney Cancer
Colon Cancer
Esophagus Cancer
Conditions: Official terms:
Neoplasms
Kidney Neoplasms
Esophageal Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Dose Escalation "3+3" Design
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AUR106
Description:
Once or twice daily
Arm group label:
AUR106
Summary:
A Phase I, Open Label, Dose-Escalation, First in Human (FIH) Study Evaluating the Safety,
Pharmacokinetics, Pharmacodynamics and Efficacy of AUR106 in Patients with Select
Relapsed Advanced Malignancies (JIVAN).
Detailed description:
This is a Phase I, Open Label, Dose-Escalation, First in Human (FIH) study in adult
patients with select relapsed advanced malignancies. The safety and tolerability of oral
AUR106 will be evaluated in patients with selected advanced solid tumors (Non-small cell
lung cancer, Gastric cancer, Urothelial cancer, Kidney cancer, Colon cancer and
Esophageal cancer), who do not have any available curative or life prolonging treatment
options and have exhausted all effective locally available therapies. The traditional 3+3
design for dose escalation will be used to evaluate safety, PK/PD and determine the
Optimal Biological Dose (OBD) of AUR106, as a single agent. The Optimal Biological Dose
will be selected using a totality of safety, PK and PD data.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Provide signed and dated informed consent and agree to comply with all study related
activities.
2. Male or female patients aged ≥ 18 years.
3. Patients have to meet the following criteria:
- Pathological diagnosis of the following solid tumors: Non-small cell lung
cancer, Gastric cancer, Urothelial cancer (includes bladder cancer and cancers
of ureter / renal pelvis), Kidney cancer, Colon cancer, Esophageal cancer).
- Standard curative or life prolonging measures do not exist, and patient must
have exhausted all effective therapies, available locally. At a minimum,
patients should have received at least 2 lines of therapy in the metastatic
setting.
- Standard treatment options provided to the patients are exhausted.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Patients
with disease related ECOG 2 are allowed, in addition to ECOG 0 and 1).
5. Acceptable bone marrow as described below:
- ANC ≥ 1500/μL (without WBC growth factor support).
- Platelet count ≥ 100,000/μL without transfusion support.
- Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb).
6. Acceptable organ function as described below:
- Total Bilirubin ≤ 1.5 x ULN (Patients with known Gilbert's syndrome are allowed
with a Total Bilirubin ≤ 2.5 x ULN).
- AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases).
- ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases).
- Creatinine clearance (CrCl) ≥ 60 mL/min (either measured or estimated by the
Cockcroft-Gault formula). (Cockcroft-Gault formula for estimated creatinine
clearance [eCrCl]: eCrCl = [140 - Age] × Weight [kg] × [0.85 if Female] / [72 ×
serum creatinine (mg/dL)]).
- Albumin ≥ 3.0 g/dL.
7. Ability to swallow and retain oral medications.
8. Negative serum pregnancy test in women of childbearing potential (WOCBP).
9. Women of childbearing potential and men who partner with such a woman of
childbearing potential must agree to use one or more of highly effective method(s)
of contraception for the duration of the study, i.e., through 28-day follow up
visit, after discontinuation of study drug(s).
10. Evidence of measurable disease per RECIST, v1.1 for solid tumors (Eisenhauer et al.
2009). Measurable disease for solid tumors is defined as at least one lesion that
can be accurately measured in at least 1 dimension with a minimum size of 10 mm for
non-nodal lesions or 15 mm in short axis for nodal lesions.
Exclusion Criteria:
1. Systemic anti-cancer therapy, such as chemotherapy, biological therapy, or
immunomodulatory drug therapy, received within the past 28 days or 5 half-lives,
whichever is longer, from the Cycle 1 Day 1 of the study.
2. Presence of an acute or chronic toxicity resulting from prior anti-cancer treatment,
with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1,
as determined by NCI CTCAE v 5.0.
3. Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field
palliative radiation is allowed and no restrictions during the screening period or
during the trial).
4. Use of any investigational agent within 28 days or 5 half-lives (whichever is
longer) prior to Cycle 1 Day 1.
5. Known symptomatic or untreated or recently treated (≤ 6 months of screening) central
nervous system (CNS) metastases. Patients with previously treated (> 6 months of
screening) and are now stable and asymptomatic, from CNS perspective, are allowed.
6. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure
requiring general anesthesia).
7. Known to be human immunodeficiency virus (HIV) positive or have an acquired
immunodeficiency syndrome-related illness.
8. Known active or chronic hepatitis B or hepatitis C infection.
9. Uncontrolled congestive heart failure (New York Heart Association [NYHA] Class 2-4),
angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery
bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3
months prior to Cycle 1 Day 1.
10. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of
cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1.
11. The QTcF (corrected QT interval Fridericia method) value in the screening ECG > 460
ms in both males and females.
12. Previous or concomitant additional malignancy, except for basal-cell or squamous
cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix; patients with
other malignancies are eligible if they have remained disease free for at least 2
years prior to trial entry and in the opinion of the investigator deemed to have a
low likelihood of recurrence.
13. Pregnant or lactating women.
14. Any clinically significant medical, psychiatric or social condition; or laboratory
abnormality that may increase the risk of trial participation or may interfere with
the informed consent process and/or with compliance with the requirements of the
trial or may interfere with the interpretation of the trial results and, in the
Investigator's opinion, would make the patient inappropriate for entry into this
trial.
15. Patients who require concomitant administration of drugs which have a high risk of
prolonging QT interval.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Omega Hospital
Address:
City:
Visakhapatnam
Zip:
530040
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Bellala Ravishankar
Phone:
+91 9849123256
Email:
rakesh.neve@gmail.com
Facility:
Name:
Unique Hospital Multispeciality and Research Institute
Address:
City:
Surat
Zip:
395002
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Ankit Patel
Phone:
+921 9825404202
Email:
drankitoncologist@gmail.com
Facility:
Name:
Kiran Multi Super Specialty Hospital
Address:
City:
Surat
Zip:
395004
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Anshul Agarwal
Phone:
+91 9969465723
Email:
anshul.onco@gmail.com
Facility:
Name:
Sankalp Speciality Hospital
Address:
City:
Nashik
Zip:
422009
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Bhushan Nemade
Phone:
+91 9766126162
Email:
drbtnemade@yahoo.co.in
Facility:
Name:
Moraya Multispeciality Hospital (Ashwin Medical Foundations)
Address:
City:
Pune
Zip:
411033
Country:
India
Status:
Not yet recruiting
Contact:
Last name:
Dr. Rakesh Neve
Phone:
+91 9881143140
Email:
dr.bellabravishankar@gmail.com
Facility:
Name:
All India Institute of Medical Sciences
Address:
City:
Bhubaneswar
Zip:
751019
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Sandip Barik
Phone:
+91 7008651823
Email:
sandip.barik1@gmail.com
Start date:
August 26, 2023
Completion date:
June 2025
Lead sponsor:
Agency:
Aurigene Discovery Technologies Limited
Agency class:
Industry
Source:
Aurigene Discovery Technologies Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05861947
