CTRI/2023/04/052088 [Registered on: 28/04/2023] Trial Registered Prospectively
Last Modified On:
18/02/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
A Phase 1 Clinical Trial of AUR106 in Patients with Relapsed Advanced Malignancies
Scientific Title of Study
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)
Trial Acronym
JIVAN
Secondary IDs if Any
Secondary ID
Identifier
Protocol AUR106-101, Version 3.0, 21 Mar 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Akhil Kumar
Designation
VP and Head, Clinical Development
Affiliation
Aurigene Oncology Limited (Subsidiary of Dr. Reddys Laboratories Limited)
Address
39-40, KIADB Industrial Area, Phase II, Electronic City, Hosur Road, Bangalore
Bangalore KARNATAKA 560100 India
Phone
9632203510
Fax
Email
akhil_k@aurigene.com
Details of Contact Person Scientific Query
Name
Dr Sapan Kumar Behera
Designation
Senior Manager and Medical Lead, Clinical Development
Affiliation
Aurigene Oncology Limited (Subsidiary of Dr. Reddys Laboratories Limited)
Address
39-40, KIADB Industrial Area, Phase II, Electronic City, Hosur Road, Bangalore
Bangalore KARNATAKA 560100 India
Phone
9438738896
Fax
Email
sapan_b@aurigene.com
Details of Contact Person Public Query
Name
Gutta Padmanabha Naidu
Designation
Clinical Project Manager
Affiliation
Aurigene Oncology Limited (Subsidiary of Dr. Reddys Laboratories Limited)
Address
39-40, KIADB Industrial Area, Phase II, Electronic City, Hosur Road, Bangalore
Bangalore KARNATAKA 560100 India
Phone
8328340009
Fax
Email
guttapadmanabha_n@aurigene.com
Source of Monetary or Material Support
Aurigene Oncology Limited (A subsidiary of Dr. Reddys Laboratories Limited), 39-40, KIADB Industrial Area, Phase II, Electronic City, Hosur Road, Bangalore, KARNATAKA, 560100,
India
Primary Sponsor
Name
Aurigene Oncology Limited (A subsidiary of Dr. Reddys Laboratories Limited)
Address
39-40, KIADB Industrial Area, Phase II, Electronic City, Hosur Road, Bangalore, KARNATAKA, 560100, India
Basement, Clinical Trial Room No: 85, Indrayani Hospital and Cancer Institute, Alnadi-Chakan Road,
Alandi Devachi, Charholi Budruk, Tal: Khed, Dist: Pune, Maharashtra - 412105
Pune MAHARASHTRA
8412069900
drjayantgawande71@gmail.com
Dr Anshul Agarwal
Kiran Multi Super Specialty Hospital
Second Floor. Clinical Research Department (beside blood bank area), Kiran Multi Super Specialty Hospital,
Vasta Devdi Road, Near Sumul Dairy Road,
Katargam, Surat, Gujarat -395004 Surat GUJARAT
9969465723
anshul.onco@gmail.com
Dr Viraj Borgaonkar
Krupamayi Hospital
Department of clinical research,Akshay Opp. Youth hostel, Near Baba Petrol Pump, station road, Aurangabad, Maharashtra, India.-431001 Aurangabad MAHARASHTRA
9673073555
research@krupamayihospitals.in
Dr PK Chaitanya
MNJ Institute Of Oncology & Regional Cancer Centre
11, Clinical trial dept, Old building 3rd floor Beside Niloufer Hospital, Red Hills, Lakdi Ka Pool-Hyderabad-Telangana500004 Hyderabad TELANGANA
8897199994
mnjiorccchaithanya@gmail.com
Dr Rakesh Suresh Neve
Moraya Multispeciality Hospital (Ashwin Medical Foundations)
Room No-7, Research Department, Ground Floor, Ashwin Medical Foundation Moraya Multispeciality Hospital, Opposite PMP Bus Stop, Powerhouse Chowk, Chinchwadgaon, Pune, Maharasthra - 411033 Pune MAHARASHTRA
Sujan Surgicals Cancer Hospital & Amravati Cancer Foundation
52/B, Shankar Nagar main Road, Amaravati-444605, Maharashtra, India Amravati MAHARASHTRA
7212671496
dr_rsarora@reddiffmail.com
Dr Ankit Baldev Bhai Patel
Unique Hospital Multispeciality and Research Institute
Basement, Clinical Research Department, Unique Hospital Multispeciality and Research Institute, Opp. Kiran Motor, Near Canal, Civil Hospital-Char Rasta Sosyo Circle Canal Rd, Surat, Gujarat - 395002 Surat GUJARAT
Institutional Ethics Committee-HCG Curie City Cancer Centre
Approved
Kiran Hospital Ethics Committee
Approved
Manavata Clinical Research Institutional Ethics committee
Approved
Moraya Institutional Ethics Committee
Approved
Narsimha Saraswati Medical Foundation Ethics Committee
Approved
Navsanjeevani Hospital Ethics Committee
Approved
Poona Medical Research Foundation Institutional Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C768||Malignant neoplasm of other specified ill-defined sites,
Intervention / Comparator Agent
Type
Name
Details
Intervention
AUR106
25 mg and 100 mg tablets for oral administration, either once or twice daily, approximately 4 cycles (i.e., 112 days) treatment
Comparator Agent
Not applicable
Not applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
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 also 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):(140
– Age) × Weight (kg) × (0.85 if Female)/(72 × serum creatinine in 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) for 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.
ExclusionCriteria
Details
1) Systemic anti-cancer therapy, such as chemotherapy, or biological therapy, 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, or 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 Investigators 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.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Primary Endpoint:
• Optimal Biological Dose (OBD) and the overall safety profile of single agent AUR106 in patients with relapsed advanced solid tumor malignancies.
• PK profile of the study drug in fasting and fed conditions.
During first 28 Days (Cycle 1)
Secondary Outcome
Outcome
TimePoints
Secondary Endpoint:
• Adverse Events as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0), timing, seriousness, and relationship to study therapy.
• Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE Version 5.0) and timing.
Exploratory Endpoint:
• Pharmacodynamics (PD) effects on selected biomarkers.
During first 28 Days (Cycle 1)
Target Sample Size
Total Sample Size="30" Sample Size from India="30" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
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 select 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.