Trial Title:
A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)
NCT ID:
NCT05984147
Condition:
Relapsed Advanced Lymphomas
Conditions: Official terms:
Lymphoma
Conditions: Keywords:
Relapse Advanced Lymphomas
Diffuse large B-cell lymphoma
Follicular lymphoma
Mature T/NK-cell lymphomas
Other Hodgkin lymphoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Sequential Assignment Dose Escalation "3+3" Design
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AUR108
Description:
3 Days dosing, and 4 days no dose in a week
Arm group label:
AUR108, 50mg to 300mg
Summary:
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced
lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics,
pharmacodynamics, and optimal biological dose.
Detailed description:
This is a Phase I, Open Label, Dose-Escalation, First-in-Human study in adult patients
with select relapsed advanced lymphomas. The safety and tolerability of oral AUR108 will
be evaluated in patients with Non-Hodgkin lymphoma and Hodgkin lymphoma 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 the safety, pharmacokinetics/pharmacodynamics, and determine the
Optimal Biological Dose of AUR108 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. Males or 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:
1. ANC ≥ 1000/μL (without WBC growth factor support)
2. Platelet count ≥ 75,000/μL without transfusion support
3. Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)
4. Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome are
allowed with a Total Bilirubin ≤ 2.5 x ULN)
5. AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
6. ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
7. Creatinine clearance (CrCl) ≥ 30 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)]).
4. Ability to swallow and retain oral medications
5. Histo-pathological diagnosis of a Non-Hodgkin lymphoma orHodgkin Lymphoma. Note: The
lymphoma should be either in Stage III or IV according to Lugano classification
(Cheson BD et al, 2014) at screening.
6. In the case of subjects who have lymphoma for which high-dose chemotherapy and
autologous stem cell transplantation (HDASCT) is considered a standard curative
therapy, eligibility for this study requires that the subject's disease has relapsed
after HDASCT, that the subject is not eligible for HD-ASCT, or that the subject has
refused HD-ASCT.
7. In the case of subjects who have lymphoma for which CAR-T therapy is considered a
standard therapy, eligibility for this study requires that the subjects disease has
relapsed after CAR-T, or that the subject has refused CAR-T, or that the CAR-T
therapy is not accessible to the patient.
8. Evidence of measurable disease as per Lugano Criteria for Lymphoma (Cheson BD et al,
2014).
9. Standard curative measures do not exist, and patient must have exhausted all
effective therapies, available locally.
1. At a minimum, the 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.
2. Any cancer patient with access to any effective therapy must not be enrolled.
Exclusion Criteria:
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) is allowed.
2. Presence of an acute or chronic toxicity resulting from prior anticancer 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. Patients with cutaneous lymphomas, mycosis fungoides (MF) or Sézary syndrome (SS).
6. Primary CNS lymphoma
7. Known symptomatic or untreated or recently treated (≤ 6 months of screening) central
nervous system (CNS) lymphoma. Patients with previously treated (> 6 months of
screening) CNS lymphoma and are now stable and asymptomatic, from CNS perspective,
are allowed
8. Patients with lymphoma that requires immediate cytoreductive therapy
9. Patients with lymphoma that requires immediate cytoreductive therapy
10. Patients on the drugs which are sensitive substrates of CYP2C8 and cannot be
discontinued at least one week prior to Cycle 1 Day 1
11. Patients on the drugs which are sensitive substrates of either Poglycoprotein (P-gp)
or breast cancer resistance protein (BCRP) and cannot be discontinued at least one
week prior to Cycle 1 Day 1
12. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure
requiring general anesthesia)
13. 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.
14. Known to be human immunodeficiency virus (HIV) positive or have an acquired
immunodeficiency syndrome-related illness
15. Known active or chronic hepatitis B (HbsAg +ve) or hepatitis C infection (HCV
antibody +ve)
16. The patient who is expected to require any other form of antineoplastic therapy or
targeted therapy while on study.
17. 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
18. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of
cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1.
19. QTc (Bazzett) interval >460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose.
20. 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 (e.g. 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 patient's ability to participate in the study
21. 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 Cycle 1 Day 1.
22. 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.
23. Positive pregnancy test for women of child-bearing potential (WOCBP) at the
screening or enrolment visit
24. 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, cervical
cap).
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Omega Cancer Hospitals
Address:
City:
Visakhapatnam
Zip:
530040
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr Bellala Ravishankar
Phone:
9849123256
Email:
dr.bellalaravishankar@gmail.com
Facility:
Name:
HCC Happiness Care and Cure Multispeciality Hospital
Address:
City:
Ahmedabad
Zip:
380015
Country:
India
Status:
Recruiting
Contact:
Last name:
Akash Patel, MBBS
Phone:
8826001414
Email:
drakash.cr@gmail.com
Facility:
Name:
Unique Hospital
Address:
City:
Surat
Zip:
395002
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Ankit Patel
Phone:
9825404202
Email:
drankitoncologist@gmail.com
Facility:
Name:
Kiran Multi Speciality Hospital
Address:
City:
Surat
Zip:
395004
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Anshul Agarwal
Phone:
8657068668
Email:
drankitoncologist@gmail.com
Facility:
Name:
Super Specialty Hospital (G.M.C) Srinagar
Address:
City:
Srinagar
Zip:
190010
Country:
India
Status:
Recruiting
Contact:
Last name:
Javvid Muzamil, MBBS
Phone:
7006787372
Email:
javvidmd@gmail.com
Facility:
Name:
KLES Dr Prabhakar Kore Hospital and MRC
Address:
City:
Belagam
Zip:
590010
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Rohan Bhise
Phone:
9448866712
Email:
rohanbhise30@gmail.com
Facility:
Name:
Amrita Institute of Medical Sciences (AIMS)
Address:
City:
Kochi
Zip:
682041
Country:
India
Status:
Recruiting
Contact:
Last name:
Neeraj Siddhartan, MBBS
Phone:
9946047464
Email:
neerajsidharthan@aims.amrita.edu
Facility:
Name:
Sujan Surgical Cancer Hospital and Amravati Cancer Foundation
Address:
City:
Amaravati
Zip:
444606
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Rajendrasingh Arora
Phone:
9823097573
Email:
rsaroradr@gmail.com
Facility:
Name:
Kolhapur Cancer Centre
Address:
City:
Kolhapur
Zip:
416234
Country:
India
Status:
Recruiting
Contact:
Last name:
Yogesh Anap, MBBS
Phone:
9420635556
Email:
yogesh.anap1@gmail.com
Facility:
Name:
All India Institute of Medical Sciences
Address:
City:
Nagpur
Zip:
441108
Country:
India
Status:
Recruiting
Contact:
Last name:
Vishvdeep Khushoo, MBBS
Phone:
9903559446
Email:
vkhushoo@gmail.com
Facility:
Name:
HCG Manavata Cancer Centre
Address:
City:
Nashik
Zip:
422002
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Rajesh Nagarkar
Phone:
9823061929
Email:
drraj@manavatacancercentre.com
Facility:
Name:
Deenanath Mangeshkar Hospital & Research Center
Address:
City:
Pune
Zip:
411004
Country:
India
Status:
Recruiting
Contact:
Last name:
Chetan Deshmukh, MBBS
Phone:
9850811449
Email:
drchetandeshmukh@gmail.com
Facility:
Name:
Mumbai Onco Care Centre
Address:
City:
Mumbai
Zip:
400056
Country:
India
Status:
Recruiting
Contact:
Last name:
Ashish Joshi, MBBS
Phone:
9324378234
Email:
ashjoshi44@mocindia.co.in
Facility:
Name:
MTES Sanjeevan Hospital
Address:
City:
Pune
Zip:
411004
Country:
India
Status:
Recruiting
Contact:
Last name:
Reshma Puranik, MBBS
Phone:
9552544910
Email:
drpreshma@gmail.com
Facility:
Name:
All India Institute of Medical Sciences
Address:
City:
Delhi
Zip:
10029
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr Deepam Pushpam
Phone:
9650629370
Email:
deepampushpam@gmail.com
Facility:
Name:
Sparsh Hospital and Critical Care (P) Ltd.
Address:
City:
Bhubaneswar
Zip:
751007
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Ghanashyam Biswas
Phone:
9937500878
Email:
drgbiswas@gmail.com
Facility:
Name:
MNJ Institute of Oncology and Regional Cancer Centre
Address:
City:
Hyderabad
Zip:
500004
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. P.K. Chaithanya
Phone:
8897199994
Email:
mnjiorccchaithanya@gmail.com
Facility:
Name:
Tata Medical Center
Address:
City:
Kolkata
Zip:
700160
Country:
India
Status:
Recruiting
Contact:
Last name:
Arijit Nag, MBBS
Phone:
9051121161
Email:
javvidmd@gmail.com
Facility:
Name:
Post Graduate Institute of Medical Education & Research,
Address:
City:
Chandigarh
Zip:
160012
Country:
India
Status:
Recruiting
Contact:
Last name:
Gaurav Prakash
Phone:
9914209678
Email:
drgp04@gmail.com
Facility:
Name:
Rajiv Gandhi Cancer Institute and Research Centre
Address:
City:
Delhi
Zip:
110085
Country:
India
Status:
Recruiting
Contact:
Last name:
Narendra Agrawal, MBBS
Phone:
9868764808
Email:
narendra_ag1@rediffmail.com
Start date:
October 19, 2023
Completion date:
August 30, 2027
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/NCT05984147
