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CTRI Number  CTRI/2022/09/046061 [Registered on: 30/09/2022] Trial Registered Prospectively
Last Modified On: 15/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A Phase I, Open label, First in Human Dose-Escalation and Dose Expansion Study 
Scientific Title of Study   A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR105 in Patients with Relapsed Advanced Malignancies (SURYA-1) 
Trial Acronym  SURYA-1 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol AUR105-101 Version 3.0, 14 Jun 2022  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 Discovery Technologies limited  
Address  A39-40, KIADB Industrial Area, Phase II, Electronic City Hosur Road (Subsidiary of Dr. Reddys Laboratories limited) Bangalore KARNATAKA 560100 India

Bangalore
KARNATAKA
560100
India 
Phone  9427181182  
Fax    
Email  Akhil_k@aurigene.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Divyesh Mandavia 
Designation  Associate Director and Medical Lead Clinical Development  
Affiliation  Aurigene Discovery Technologies limited  
Address  A39-40, KIADB Industrial Area, Phase II, Electronic City Hosur Road (Subsidiary of Dr. Reddys Laboratories limited) Bangalore KARNATAKA 560100 India

Bangalore
KARNATAKA
560100
India 
Phone  9427181182  
Fax    
Email  divyesh_m@aurigene.com  
 
Details of Contact Person
Public Query  
Name  Oduru Suresh Reddy 
Designation  Assistant Clinical Project Manager 
Affiliation  Aurigene Discovery Technologies limited  
Address  A39-40, KIADB Industrial Area, Phase II, Electronic City Hosur Road (Subsidiary of Dr. Reddys Laboratories limited) Bangalore KARNATAKA 560100 India

Bangalore
KARNATAKA
560100
India 
Phone  9866225593  
Fax    
Email  suresh_o@aurigene.com  
 
Source of Monetary or Material Support  
Aurigene Discovery Technologies Limited  
 
Primary Sponsor  
Name  Aurigene Discovery Technologies Limited  
Address  A subsidiary of Dr. Reddys Laboratories Limited 39-40 KIADB Industrial Area Phase II Electronic City Hosur Road Bangalore 560 100 Karnataka India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepam Pushpam  All India Institute of Medical Sciences  ALL India Institute of medical Sciences, 1st Floor, Department of Medical Oncology, Ansari Nagar, New Delhi -110029
New Delhi
DELHI 		 9650629370

deepampushpam@gmail.com 
Dr Sourav Mishra  All India Institute of Medical Sciences  All India Institute of Medical Sciences,Clinical Trial Department. Sijua, Po - Patrapada, Bhubaneswar, Odisha-751019
Anugul
ORISSA 		 7008651823

drskmishra1984@gmail.com 
Dr Nandish Kumar  HCG Cancer Centre  HCG Cancer Centre, Clinical Trial Department. 110/A, Khuba Plot, Station Road, Kalaburagi, Karnataka-585102
Gulbarga
KARNATAKA 		 7259029517

drnandish.j@hcgel.com 
Dr Lakshmi Priyadarshini  HCG City Cancer Centre  33-25-33 CH Venkata, Gopala Krishnaiah St, Suryaraopeta, Vijayawada, Andhra Pradesh 520002
Krishna
ANDHRA PRADESH 		 9966030988

priyadarshini006@gmail.com 
Dr Satheesh CT  Healthcare Global Enterprises Limited  Clinical Trial Department, HCG Tower, 512, Tower - 4, 5th Floor, Kalinga Rao Road, Sampangi Ram Nagar, Bangalore, Karantaka-560027
Bangalore
KARNATAKA 		 9242698750

drsatheeshct@gmail.com 
Dr Lalatendu Moharana  IMS&SUM Hospital  IMS&SUM Hospital,Gastro Surgery Department, 4th Floor,Room No-04. K-8, Kalinga Nagar, Ghatikia, Bhubaneswar, Odisha-751003
Khordha
ORISSA 		 9538752579

drlalatendu@gmail.com 
Dr Vandanasetti Santhosh  Kailash Cancer Hospital and Research Centre  Kailash Cancer Hospital & RC, Department of clinial Research, Muniseva Ashram, Goraj, Waghodia, Vadodara, Gujarat-391760
Vadodara
GUJARAT 		 9427423693

Vandanasetti.santhosh@greenashram.org 
Dr Viraj Vijay Borgaonkar   Krupamayi Hospital  Krupamayi Hospital,Research Department, Ground floor. "Akshay", Opp. Youth Hostel, Near Baba Petrol Pump, Railway Station Road, Aurangabad- 431001
Aurangabad
MAHARASHTRA 		 9673073555

viraj.oncosurg@gmail.com 
Dr Rakesh Neve  Moraya Multi-Speciality Hospital  Moraya Multi-Speciality Hospital, Research Department. Opposite PMP Bus Stop, Power House Chowk, Chinchwadgaon, Pune, Maharasthra-411033
Pune
MAHARASHTRA 		 9881143140

rakesh.neve@gmail.com 
Dr B Ravi Shankar  Omega Hospitals  Plot no-04, Chinagadili, Arilova, Visakhapatnam, Andhra Pradesh-530040
Visakhapatnam
ANDHRA PRADESH 		 9849123256

dr.bellalaravishankar@gmail.com 
Dr Ankolikar Srikant  PDEAs Ayurved Rugnalaya & Sterling Multispeciality Hospital   Sector No-27, Behind Sweet Junction, Nigdi,Pradhikaran,Pune-411044
Pune
MAHARASHTRA 		 9527239023

ankolikarshrikant@gmail.com 
Dr Ghanshyam Biswas  Sparsh Hospital and Critical Care (P) Ltd  Sparsh Hospital and Critical Care (P) Ltd., Oncology wing, Ground Floor, Research Room. A/407, Saheed Nagar, Bhubaneswar, Odisha-751007
Khordha
ORISSA 		 9937500878

drgbiswas@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
HCG Central Ethics Committee, Bangalore  Submittted/Under Review 
HCG Curie City Cancer Center Institutional Ethics Committee  Approved 
Institutional Ethics Committee All India Institute of Medical Sciences, Bhubaneswar  Approved 
Institutional Ethics Committee All India Institute of Medical Sciences, Delhi  Approved 
Institutional Ethics Committee HCG Cancer Centre Kalaburagi  Submittted/Under Review 
Institutional Ethics Committee IMS and SUM Hospital  Submittted/Under Review 
Institutional Ethics Committee Kailash Cancer Hospital and Research Centre   Approved 
Institutional Ethics Committee Krupamayi Hospitals  Approved 
Institutional Ethics Committee Omega Hospitals  Approved 
Institutional Ethics Committee Sparsh Hospitals Critical Care Ltd.  Submittted/Under Review 
Institutional Ethics Committee Sterling Multi-Speciality Hospital  Approved 
Moraya 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  AUR-105  50 and 100mg orally Once Daily entire duration of the study 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Males and females ≥ 18 years of age .
2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
3. Acceptable bone marrow and organ function at screening as described below:
ANC ≥ 1500/μL (without WBC growth factor support)
Platelet count ≥ 100,000/μL without transfusion support (Patients with lymphoma are allowed with Platelet count ≥ 75,000 / μL)
Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)
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) greater than equal to 60 mL/min (either measured or estimated by the Cockcroft Gault formula). (Cockcroft Gault formula for estimated creatinine clearance (eCrCl) : eCrCl (140– Age)xWeight (kg)x(0.85 if Female)/ (72xserum creatinine mg/dL.)
4. Ability to swallow and retain oral medications
5. Histo pathological diagnosis of a solid tumor, Non Hodgkin lymphoma or Hodgkin Lymphoma
Note: The solid tumors must be in Stage IV at screening. The lymphoma could be either in Stage III or IV according to Lugano classification (Cheson et al. 2014) at screening.
Evidence of measurable disease per RECIST v1.1 for solid tumors (Eisenhauer et al. 2009) and per Lugano Criteria for Lymphoma (Cheson et al. 2014).
7. Standard curative measures do not exist and patient must have exhausted all effective therapies available locally.
7a. At a minimum solid tumor patients must have received at least two lines of systemic therapies in the metastatic incurable settings (these two lines must be in the metastatic setting and not in the earlier stage of cancer).
7b. At a minimum lymphoma patients must have received at least 2 prior lines of systemic therapies. These systemic therapies could be either in the stage II , III or IV.
(Note: Any cancer patient with access to any effective therapy must not be enrolled)

 
 
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.
Note: Concomitant use of low dose prednisone (up to 10 mg/day) or medroxyprogesterone is allowed.
Note: Patients with CRPC (castrate resistant prostate cancer) should continue to receive ongoing medical castration with LHRH analogues and such patients are allowed.
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. Use of moderate / strong CYP3A4 inhibitors/inducers or moderate / strong P-gp inhibitor/inducers within 2 weeks or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1
6. Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) metastases or CNS lymphoma. Patients with previously treated (> 6 months of screening) CNS metastases or CNS lymphoma and are now stable and asymptomatic from CNS perspective are allowed.
7. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia)
8. Patients with leukemia or myelodysplastic syndrome or multiple myeloma
9. Active infection requiring systemic therapy. Prophylactic use of antibiotics is allowed. Any infection detected during screening period which is resolved adequately according to investigator before the Cycle 1 Day 1 is allowed.
10. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome related illness
11 Known active or chronic hepatitis B (HBsAg +ve) or hepatitis C infection (HCV antibody +ve)
12.The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study.
13.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
14. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months before Cycle 1 Day 1
15. QTc (Bazzett) interval >450 ms for male patients or >460 ms for female patients on ECG at screening and/or at Cycle 1 Day 1 pre-dose
16.Uncontrolled intercurrent illness including but not limited to symptomatic congestive heart failure uncontrolled hypertension unstable angina pectoris cardiac arrhythmia active peptic ulcer disease or significant gastritis active bleeding diatheses presence of any major medical illness eg renal hepatic hematologic gastrointestinal endocrine pulmonary or psychiatric illness social situations or clinically significant laboratory ECG abnormalities at screening any or a combination of illnesses which in the opinion of the PI may either put the patient at risk because of participation in the study or influence the results or the patients ability to participate in the study
17. Current swab positive or suspected (under investigation) Covid-19 infection or fever and other signs or symptoms suggestive of Covid-19 infection with recent contact of person(s) with confirmed Covid-19 infection, at screening or Day 1 of Cycle 1
18. History of another primary malignancy within 5 years prior to starting study drug-except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study
19. Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening or enrolment visit
20. Lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods (hormonal contraceptive
IUD or any double combination of male or female condom spermicidal gel diaphragm sponge or cervical cap).





 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Endpoints
First cycle DLT
Safety and tolerability of AUR105 as measured by NCI CTCAE v 5.0
Recommended Phase 2 Dose (RP2D)
PK parameters including but not limited to Cmax, Cmin, Tmax, AUC0-t, AUC0-last, MRT and t½
Comparison of PK parameters in fasting and fed conditions
 		 During first 28 Days (Cycle 1) 
 
Secondary Outcome  
Outcome  TimePoints 
Exploratory Endpoints:
PD biomarkers
Efficacy assessments overall response rates, duration of response, PFS etc. as measured by RECIST 1.1 response criteria for solid tumor (Eisenhauer et al. 2009), Lugano Criteria for Lymphoma (Cheson et al. 2014)
Change in Tumor Specific Markers like PSA in Castrate Resistant Prostate Cancer, CA-125 in ovarian cancer, CEA in colorectal cancer
 		 43 Days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   03/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a multi-center, open-label, First in Human, Phase 1 study of AUR 105 in adult patients with advanced malignancies.

 

The study will have two parts: a Dose Escalation Part and Dose Expansion Part. 
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