Trial Title:
First in Human, Dose Escalation, Dose Expansion Study of AUR105
NCT ID:
NCT05605119
Condition:
Solid Tumor, Adult
Non-hodgkin Lymphoma
Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
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" dose escalation
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AUR105
Description:
Once daily
Arm group label:
AUR105 50mg to 750mg
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.
Detailed description:
This is a Phase I, Open label First in Human Study in adult patients with relapsed
advanced malignancies.
The study will have two parts. Dose escalation part and Dose expansion part
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Males and females ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- 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) ≥ 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)]).
- Ability to swallow and retain oral medications
- Histo-pathological diagnosis of a solid tumor, Non-Hodgkin lymphoma or Hodgkin
Lymphoma
- 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).
- Standard curative measures do not exist, and patient must have exhausted all
effective therapies, available locally.
1. 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).
2. 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.
Exclusion Criteria:
- 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.
- 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
- 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)
- Use of any investigational agent within 28 days or 5 half-lives (whichever is
longer) prior to Cycle 1 Day 1
- 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 (The list of these medications is provided in the first four rows of
Table 5)
- 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
- Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure
requiring general anesthesia)
- Patients with leukemia or myelodysplastic syndrome or multiple myeloma
- Active infection requiring systemic therapy.
-
10. 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.
- Known to be human immunodeficiency virus (HIV) positive or have an acquired
immunodeficiency syndrome-related illnessKnown active or chronic hepatitis B (HBsAg
+ve) or hepatitis C infection (HCV antibody +ve)
- The patient who is expected to require any other form of antineoplastic therapy or
targeted therapy while on study.
- 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
- Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of
cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1
- 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 predose.
- 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
- Current swab-positive or suspected (under investigation) Covid19 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
- 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.
- Positive pregnancy test for women of child-bearing potential (WOCBP) at the
screening or enrolment visit
- 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:
HCG City Cancer Center
Address:
City:
Vijayawada
Zip:
520002
Country:
India
Status:
Recruiting
Contact:
Last name:
Lakshmi Priyadarshini, MBBS
Phone:
9966030988
Email:
priyadarshini006@gmail.com
Facility:
Name:
Omega Hospitals
Address:
City:
Visakhapatnam
Zip:
530040
Country:
India
Status:
Recruiting
Contact:
Last name:
Bellala Ravi Shankar, MBBS
Phone:
9849123256
Email:
dr.bellalaravishankar@gmail.com
Facility:
Name:
Kailash Cancer Hospital and Research Centre
Address:
City:
Vadodara
Zip:
391760
Country:
India
Status:
Recruiting
Contact:
Last name:
Santhosh Dr Vandanasetti
Phone:
9427423693
Email:
Vandanasetti.santhosh@greenashram.org
Facility:
Name:
Moraya Multi-Speciality Hospital
Address:
City:
Pune
Zip:
411033
Country:
India
Status:
Recruiting
Contact:
Last name:
Rakesh Dr Neve
Phone:
9881143140
Email:
rakesh.neve@gmail.com
Facility:
Name:
Krupamayi Hospital
Address:
City:
Aurangabad
Zip:
431001
Country:
India
Status:
Recruiting
Contact:
Last name:
Viraj Vijay Dr Borgaonkar
Phone:
9673073555
Email:
viraj.oncosurg@gmail.com
Facility:
Name:
Sparsh Hospital and Critical Care
Address:
City:
Bhubaneswar
Zip:
751007
Country:
India
Status:
Recruiting
Contact:
Last name:
Ghanshyam Dr Biswas
Phone:
9937500878
Email:
drgbiswas@gmail.com
Facility:
Name:
All India Institute of Medical Sciences
Address:
City:
Bhubaneswar
Zip:
751019
Country:
India
Status:
Recruiting
Contact:
Last name:
Sourav Dr Mishra
Phone:
7008651823
Email:
drskmishra1984@gmail.com
Facility:
Name:
IMS&SUM Hospital
Address:
City:
Bhubaneswar
Zip:
751003
Country:
India
Status:
Recruiting
Contact:
Last name:
Lalatendu Dr Moharana
Phone:
9538752579
Email:
drlalatendu@gmail.com
Facility:
Name:
ALL India Institute of medical Scieneces
Address:
City:
New Delhi
Zip:
110029
Country:
India
Status:
Recruiting
Contact:
Last name:
Deepam Dr Pushpam
Phone:
9650629370
Email:
deepampushpam@gmail.com
Start date:
November 30, 2022
Completion date:
May 30, 2026
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/NCT05605119
