Trial Title:
A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)
NCT ID:
NCT05865002
Condition:
Relapsed Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Relapse malignant neoplasm
Non small cell lung cancer
Gastric cancer
Colon cancer
Esophageal cancer
Kidney cancer
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" Design
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AUR107
Description:
Once daily
Arm group label:
AUR107, 5mg to 200mg
Summary:
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced
malignancies will be done to assess AUR107 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 malignancies. The safety and tolerability of oral AUR107
will be evaluated in patients with selected 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 the safety, pharmacokinetics/pharmacodynamics,
and determine the Optimal Biological Dose of AUR107 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 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:
1. ANC ≥ 1500/μL (without WBC growth factor support)
2. Platelet count ≥ 100,000/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) ≥ 60 mL/min (either measured or estimated by the
Cockcroft-Gault formula).
4. Ability to swallow and retain oral medications.
5. Histopathological diagnosis of a solid tumor. Note: The solid tumors must be in
Stage IV at screening.
6. Evidence of measurable disease per RECIST, v1.1 for solid tumors.
7. Standard curative measures do not exist, and the patient must have exhausted all
effective therapies available locally.
Notes:
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. Any cancer patient with access to any effective therapy must not be enrolled
Exclusion Criteria:
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 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 analogs, and such patients are allowed.
2. Presence of 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)
• Use of any investigational agent within 28 days or 5 half-lives (whichever is
longer) prior to Cycle 1 Day 1.
4. Use of drugs which are moderate / strong CYP3A4 inducers and/or drugs which are
predominantly metabolized by CYP3A4 within 1week or 5 half-lives (whichever is
longer) prior to Cycle 1 Day 1.
• Note: This class of drugs are also prohibited during DLT evaluation period and
must be either avoided or used with caution beyond DLT evaluation period.
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) CNS metastases 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. Patients with leukemia, myelodysplastic syndrome, multiple myeloma, or lymphoma.
8. Active infection requiring systemic therapy. Note: Prophylactic use of antibiotics
is allowed. Any infection detected during the screening period which is resolved
adequately according to investigator before the Cycle 1 Day 1, is allowed.
9. Known to be human immunodeficiency virus (HIV) positive or have an acquired
immunodeficiency syndrome-related illness.
10. Known active or chronic hepatitis B (HBsAg +ve) or hepatitis C infection (HCV
antibody +ve).
11. The patient who is expected to require any other form of antineoplastic therapy or
targeted therapy while on study.
12. 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.
13. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of
cardiac dysrhythmias in the past 3 months, before Cycle 1 Day 1.
14. QTc (Bazzett) interval >460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose.
15. 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.
16. 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
the person(s) with confirmed Covid-19 infection, at screening or Day 1 of Cycle 1.
17. Positive pregnancy test for women of childbearing potential (WOCBP) at the screening
or enrolment visit.
18. Lactating women or WOCBP who are neither surgically sterilized nor willing to use
reliable contraceptive methods. (hormonal contraceptive, IUD, or any double
combination of the male or female condom, spermicidal gel, diaphragm, sponge,
cervical cap).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HCG City Cancer Centre
Address:
City:
Vijayawada
Zip:
520002
Country:
India
Status:
Not yet recruiting
Contact:
Last name:
Dr Lakshmi Priyadarshini
Phone:
+91 9966030988
Email:
priyadarshini009@gmail.com
Facility:
Name:
Omega Hospital
Address:
City:
Visakhapatnam
Zip:
530040
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Bellala Ravishankar
Phone:
+91 9849123256
Email:
rakesh.neve@gmail.com
Facility:
Name:
Unique Hospital Multispeciality and Research Institute
Address:
City:
Surat
Zip:
395002
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Ankit Patel
Phone:
+91 9825404202
Email:
drankitoncologist@gmail.com
Facility:
Name:
Vydehi Institute of Medical Sciences and Research Centre
Address:
City:
Bangalore
Zip:
560066
Country:
India
Status:
Recruiting
Contact:
Last name:
Shashidhar V Karpurmath, MBBS
Phone:
8861085629
Email:
shashivk5@gmail.com
Facility:
Name:
K R Hospital
Address:
City:
Mysore
Zip:
570001
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Mukesh S
Phone:
+91 9886873788
Email:
dal_muk1@hotmail.com
Facility:
Name:
Grant Medical Foundation Ruby Hall Clinic
Address:
City:
Pune
Zip:
411001
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Minish Jain
Phone:
+91 9823133390
Email:
minishjain009@gmail.com
Facility:
Name:
Krupamayi Hospital
Address:
City:
Aurangabad
Zip:
431001
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr Viraj Vijay Borgaonkar
Phone:
+91 9673073555
Email:
viraj.oncosurg@gmail.com
Facility:
Name:
All India Institute of Medical Sciences
Address:
City:
New Delhi
Zip:
110029
Country:
India
Status:
Recruiting
Contact:
Last name:
Dr. Deepam Pushpam
Phone:
+91 9650629370
Email:
deepampushpam@gmail.com
Start date:
September 5, 2023
Completion date:
June 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/NCT05865002
