CTRI/2025/01/078964 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On:
09/09/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
A Phase I clinical trial evaluating the Safety, Tolerability, and Efficacy of Oral AUR112 in Patients with Advanced Cancer
Scientific Title of Study
A Phase 1, Open Label, Dose Escalation, Multicenter, First-in-Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR112 in Patients with Relapsed Advanced Lymphoma (ADITI-1)
Trial Acronym
ADITI-1
Secondary IDs if Any
Secondary ID
Identifier
AUR112-101, Version 2.0, 28 Mar 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Akhil Kumar
Designation
Chief Medical officer
Affiliation
Aurigene Oncology Limited (Subsidiary of Dr Reddys Laboratories Limited )
Address
39-40,KIADB Industrial Area, Phase II, Electronic City Hosur Road Bangalore 560100
Bangalore KARNATAKA 560100 India
Phone
09632203510
Fax
Email
akhil_k@aurigene.com
Details of Contact Person Scientific Query
Name
Dr Suchit Dinakar Kumbhare
Designation
Sr. Manager and Medical Lead , Clinical Development
Affiliation
Aurigene Oncology Limited ( Subsidiary of Dr Reddy Laboratories Limited)
Address
39-40,KIADB Industrial Area, Phase II, Electronic City Hosur Road Bangalore 560100
Bangalore KARNATAKA 560100 India
Phone
8104730078
Fax
Email
suchit_k@aurigene.com
Details of Contact Person Public Query
Name
Mukesh Kumar Ramashre Saroj
Designation
Assistant Clinical Project Limited
Affiliation
Aurigene Oncology Limited ( Subsidiary of Dr Reddy Laboratories Limited)
Address
39-40,KIADB Industrial Area, Phase II, Electronic City Hosur Road Bangalore 560100
Bangalore KARNATAKA 560100 India
Phone
9769090249
Fax
Email
mukesh_s@aurigene.com
Source of Monetary or Material Support
Not Applicable
Primary Sponsor
Name
Aurigene Oncology Limited (Subsidiary of Dr Reddys Laboratories Limited )
Address
39-40,KIADB Industrial Area, Phase II, Electronic City Hosur Road Bangalore 560100
Armed Forces Medical College
First Floor, Department of Medical Research, Armed Forces
Medical College-Command Hospital (SC), Opp. Solapur Road, Pune-411040, Maharashtra, India Pune MAHARASHTRA
8195035551
udayj2@gmail.com
Dr Sourav Kumar Mishra
AIIMS, Bhubaneswar
G-Block, Ground Floor, OPD building, Department of
Medical Oncology & Haematology, All India Institute of
Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha
751019, India Khordha ORISSA
7008651823
drskmishra1984@gmail.com
Dr Deepam Pushpam
AIIMS, New Delhi
Departmet Of Medical Oncology
Dr. B.R.A Institute Rotary Cancer Hospital All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi - 110029 East DELHI
9650629370
deepampushpam@gmail.com
Dr Uttam Kumar Nath
AIIMS, Rishikesh
Department of Medical Oncology, Haematology, Level 6, Medical College building , Veerbhadra Road, pashulok, Rishikesh, uttarakhand, India - 249203 Dehradun UTTARANCHAL
9433982756
Uttam.haemat@aiimsrishikesh.edu.in
Dr Varun Bafna Ashok
Dr. Bafna’s Star Superspecialty Clinic and Hospital
Ground floor, Room no 01 , Rukmini Nagar, E ward, Near LIC Ground, Kolhapur, Maharashtra – 416005, India. Kolhapur MAHARASHTRA
9066565353
drvarunbafna6@gmail.com
Dr Nishad Dhakate
HCG Cancer Centre
Room No. 8, Ground Floor, Bone Marrow Transplantation counselling and hematology Department , 50/51, MaujaWanjari, Bande Nawaz Nagar, Near Automotive Square, Kalamna Ring Road, Nagpur - 440026, Maharashtra Nagpur MAHARASHTRA
7042832629
dr.nishad.dhakate@gmail.com
Dr Nataraj K S
Health Care Global Enterprises
Tower 1, 1st Floor, HCG- Bangalore institute of Oncology
#8, HCG Towers, Kalinga Rao Road,
Sampangi rama Nagar
(Bangalore) Urban Karnataka - 560027 India Bangalore KARNATAKA
9482141773
drnataraj.ks@hcgel.com
Dr Manoj Toshniwal
Jeevan Amrut Hematology Centre
First floor, Cabin No. 2 , Plot no 47, Jeevan Amrut Hospital , Parijat Nagar, Near Gokul Sweets, Sector N-4 , CIDCO, Chhatrapati Sambhaji Nagar(Aurangabad),431001, Maharashtra, India Aurangabad MAHARASHTRA
9225300842
drmanojt.jeevanamrut@gmail.com
Dr Atul Sharma
Max Super Specialty Hospital
1st Floor, Oncology OPD, Department of Medical Oncology, Max Super Speciality Hospital, Saket (A unit of Devki Devi Foundation)
2, Press Enclave Road, Saket, New Delhi- 110017 South DELHI
9818548149
atul1@hotmail.com
Dr Akash Kumar
National Cancer Institute , All India Institute of Medical Sciences
1st Floor, Academic Research Department, National Cancer Institute, All India Institute of Medical Sciences, Badsa, Haryana- 124105 Jhajjar HARYANA
9910850134
akashjha08@yahoo.com
Dr Aniket Balasaheb Mohite
Novo Solitaire Care
OPD Number 1 , Hematology Department , 2nd Floor, VittalHeights, OPP. RaddisonBluHotel, Yashwant Nagar, Kharadi, pune, Maharashtra - 411014 Pune MAHARASHTRA
9960593303
novosolitairecare@gmail.com
Dr Vinod Raosaheb Patil
Onco Life Cancer Centre, Satara
Ground floor, OPD No. 1, Department of Hematology , Onco-Life Cancer Centre, A/p, Shendre, Satara, Maharashtra – 415519- India, Satara MAHARASHTRA
Ground Floor, Medical Oncology department OPD and PI chamber, Medical Oncology Department, Siddharth Gupta Memorial Cancer Hospital
Sawangi, Meghe, Wardha - 442107, Maharashtra Wardha MAHARASHTRA
7410770773
pradnyamodak0005@gmail.com
Dr Yamini Patel
Sir Sayajirao General Hospital (SSG)
Clinical Study Room 1, 2nd floor, Department of Radiation Oncology, SSG-Hospital Road, Jail Road, Indira Avenue, Vadodara - 390001, Gujarat Vadodara GUJARAT
Ground Floor, Consultation Room-1, Srinivasam Cancer Care Multi Speciality Hospitals India Pvt Ltd.
#36, 1st A main road, 5th Cross, (Netravathi street), Maruthi nagar, Nagarbhavi, main road, Bangalore 560072. Bangalore KARNATAKA
09448055949
kcluck@gmail.com
Dr Rajendersingh Arora
Sujan Surgical and Cancer Hospital
Sujan Surgical and Cancer Hospital,Jewad Nagar, Chattri Talav Road, Amravati , Maharashtra 444605.
Amravati MAHARASHTRA
Institutional Ethics Committee Armed Forces Medical College
Approved
Institutional Ethics Committee (IEC) , Devki Foundation
Approved
Institutional Ethics Committee for Human Research (IECHR)
Approved
Institutional Ethics Committee Of DMIHER
Approved
Institutional Ethics Committee Onco Life Cancer
Approved
Institutional Ethics Committee, Alims Bhubaneswar
Approved
Institutional Review Board , Tata Medical Centre
Approved
Om Sai Onco Institutional Ethics Committee
Approved
Oriion Citicare Hospital Institutional EC
Approved
Rising Medicare Hospital and IEC
Approved
Sahyadri Hospitals Ltd. Ethics committee
Approved
Somani Hospital Ethics Committee
Approved
TMH IEC
Approved
Vedant Hospital Institutional Ethical Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C969||Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Intervention
AUR112 (dose escalation from 100-1200 mg)
Route: Oral, Frequency: Once daily, Doses: 100 mg, 200mg, 400mg, 600 mg, 900 mg, 1200 mg,
Duration: till disease progression
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 more than or equal to 18 years of age
2.ECOG of 0 or 1
3.Acceptable bone marrow and organ function at screening as described below:
a. ANC more than or equal to 1000/microL (without WBC growth factor support)
b. Platelet count: For patients with CLL more than or equal to 50,000/microL; For patients with lymphomas more than or equal to 75,000/microL without bone marrow involvement and more than or equal to 50,000/microL with bone marrow involvement. These thresholds should be qualified without platelet transfusion support.
c. Hemoglobin more than or equal to 9 g/dL (RBC Transfusion is allowed to achieve this Hb)
d.Total Bilirubin less than or equal to 1.5 x ULN; (Patients with known Gilberts syndrome are allowed with a Total Bilirubin less than or equal to 2.5 x ULN)
e. AST (SGOT) less than or equal to 3 x ULN (less than or equal to 5 X ULN if known liver metastases)
f. ALT (SGPT) less than or equal to 3 x ULN (less than or equal to 5 X ULN if known liver metastases)
g. CrCl more than or equal to 60 mL/min
4. Ability to swallow and retain oral medications.
5. Histopathological diagnosis of NHL or CLL or Hodgkin disease.
Note:
5a. The lymphoma should be either in Stage III or IV according to Lugano classification (Cheson et al. 2014) at screening.
5b. The lymphomas included in this study must fall within one of the following 2017 World Health Organization categories except lymphoma mentioned in Exclusion criterion #5:
Mature B-cell neoplasms (excluding plasma cell neoplasms, heavy chain disease, and primary central nervous system [CNS] lymphoma).
Mature T- and NK-cell neoplasms.
Hodgkin lymphomas.
5c. The CLL should be Binet Stage C/Rai stage III or IV, as per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines.
6. In the case of subjects who have lymphoma for which HD-ASCT is considered a standard curative therapy, eligibility for this study requires that the subjects disease has relapsed after HD-ASCT, or the subject is not eligible for HD-ASCT, or that the subject has refused HD-ASCT.
7. In the case of patients who have lymphoid malignancies for which CAR-T therapy is indicated, eligibility for this study requires that the disease has relapsed after CAR-T, or the patient is not eligible for CAR-T, or the patient has refused CAR-T, or the CAR-T is not available locally.
8. Evidence of measurable disease as per Lugano Criteria for Lymphoma or evidence of measurable disease as per iwCLL Criteria for CLL.
Note: Patients with Small Lymphocytic Lymphoma (SLL) alone or in combination with CLL are allowed.
9. Standard curative measures do not exist, and the patient must have exhausted all effective therapies available locally. The patients must have relapsed or refractory to at least 2 prior lines of systemic therapies for NHL or CLL, or Hodgkin disease.
Note:
Any cancer patient with access to any effective therapy locally must not be enrolled.
Patients with CLL should have documented evidence for progressive or symptomatic disease (active disease) and must have indications for treatment.
Patients with indolent lymphomas also must have indications for treatment, such as the GELF (Brice et al 1997) or BNLI criterion
ExclusionCriteria
Details
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.
Note: Concomitant use of low dose prednisone is 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 less than or equal to 1, as determined by NCI CTCAE
3. Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1.
4. Use of any investigational agent within 28 days or 5 halflives prior to Cycle 1 Day 1
5. Patients with Burkitts lymphoma, Burkitt-like lymphoma, post-transplant lymphoproliferative disease, primary mediastinal large-B cell lymphoma, cutaneous lymphomas, mycosis fungoides, or Sezary syndrome.
6. Known symptomatic or untreated or recently treated CNS lymphoma. Patients with previously treated CNS lymphoma and are now stable and asymptomatic, from CNS perspective, are allowed.
7. Patients with lymphoma that requires immediate cytoreductive therapy.
8. Patients with low-grade lymphoma or indolent lymphoma that does not meet conventional criteria for requiring treatment.
9. Patients on drugs which are inhibitors of P-gp or BCRP or UGT1A1 and when these drugs cannot be discontinued from at least one week prior to Cycle 1 Day 1.
Note: These drugs will be prohibited during Cycle 1 of therapy.
10. Major surgery less than 28 days from Cycle 1 Day 1
11. Active infection requiring systemic therapy.
Note: 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.
12. Known to be HIV positive or have an acquired immunodeficiency syndrome-related illness.
13. Known active or chronic hepatitis B or hepatitis C infection.
14. The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study.
15. Uncontrolled congestive heart failure, angina, myocardial infarction, cerebrovascular accident, cCABG, or TIA, or pulmonary embolism within 3 months prior to Cycle 1 Day 1.
16. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1.
17. QTcF interval more than 470 ms on ECG at screening or at Cycle 1 Day 1 pre-dose.
18. 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, 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.
19. Current swab-positive or suspected Covid-19 infection or fever and other signs or symptoms suggestive of Covid-19 infection with recent contact of personwith confirmed Covid-19 infection, at screening or Cycle 1 Day 1.
20. 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.
21. Positive pregnancy test for WOCBP at the screening or enrolment visit.
22. Lactating women or WOCBP or a man with a partner who has childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods during the screening period, while on AUR112 and at least 28 days after last dose.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Primary Endpoints:
To assess the safety and tolerability of single agent AUR112 in patients with relapsed advanced lymphoid malignancies
To assess the PK profile of AUR112.
To determine the doses to be recommended for evaluation in future studies.
28 DAYS
Secondary Outcome
Outcome
TimePoints
Exploratory Endpoints:
To explore the pharmacodynamics (PD) effects of AUR112
To assess efficacy of single agent AUR112
28 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)
28/01/2025
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="3" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
The study will have two parts: a Dose Escalation Part (Part 1) and Dose Expansion Part (Part 2).
In Part 1, initially, cancer patients who do not have any available curative treatment options and have exhausted all effective therapies will be enrolled in a traditional 3 +3 design in order to evaluate the safety, tolerability, PK/PD, and determine dose(s) of AUR112 as a single agent which will be investigated in future trials
In Part 2, expansion cohorts in relevant tumor types will be enrolled at the dose(s) to gather preliminary efficacy