Actively Recruiting
A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)
Led by Aurigene Discovery Technologies Limited · Updated on 2026-04-17
50
Participants Needed
37
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Acceptable bone marrow and organ function including ANC ≥ 1500/µL without growth factor support
- Platelet count ≥ 100,000/µL without transfusion support
- Hemoglobin ≥ 9 g/dL (transfusion allowed to meet this level)
- Total Bilirubin ≤ 1.5 x ULN (≤ 2.5 x ULN if Gilbert's syndrome)
- AST (SGOT) ≤ 3 x ULN (≤ 5 x ULN with known liver metastases)
- ALT (SGPT) ≤ 3 x ULN (≤ 5 x ULN with known liver metastases)
- Creatinine clearance ≥ 60 mL/min (measured or estimated)
- Ability to swallow and retain oral medication
- Histopathological diagnosis of Stage IV solid tumor
- Measurable disease per RECIST v1.1
- No available curative or life-prolonging treatments; exhausted all effective local therapies
- Received at least two lines of systemic therapy in metastatic incurable settings
You will not qualify if you...
- Received systemic anti-cancer therapy within 28 days or 5 half-lives prior to Cycle 1 Day 1 (except low-dose prednisone ≤ 10 mg/day or medroxyprogesterone)
- Presence of unresolved toxicity from prior treatment above Grade 1 except alopecia or nail changes
- Definitive radiotherapy within 21 days prior to Cycle 1 Day 1 (palliative radiation allowed)
- Use of investigational agents within 28 days or 5 half-lives prior to Cycle 1 Day 1
- Use of moderate/strong CYP3A4 inducers or substrates within 1 week or 5 half-lives prior to Cycle 1 Day 1
- Known symptomatic, untreated, or recently treated (< 6 months) CNS metastases
- Major surgery within 28 days prior to Cycle 1 Day 1
- Diagnosis of leukemia, myelodysplastic syndrome, multiple myeloma, or lymphoma
- Active infection requiring systemic therapy at screening
- HIV positive or AIDS-related illness
- Active or chronic hepatitis B or C infection
- Expected need for other anti-cancer or targeted therapy during study
- Uncontrolled heart conditions or recent cardiovascular events within 3 months
- Ongoing cardiac dysrhythmias requiring treatment or treated in past 3 months
- QTc interval > 460 ms on ECG at screening or Cycle 1 Day 1 pre-dose
- Uncontrolled intercurrent illness or significant medical abnormalities
- Current or suspected COVID-19 infection or recent contact with infected individuals
- Positive pregnancy test for women of childbearing potential
- Lactating women or women of childbearing potential not willing to use reliable contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
HCG City Cancer Centre
Vijayawada, Andhra Pradesh, India, 520002
Not Yet Recruiting
2
Omega Hospital
Visakhapatnam, Andhra Pradesh, India, 530040
Actively Recruiting
3
Post-Graduate Institute of Medical Education and Research(PGIMER)
Chandigarh, Chandigarh, India, 160012
Actively Recruiting
4
Apollo Hospital International Limited
Ahmedabad, Gujarat, India, 382428
Actively Recruiting
5
Universal Superspeciality Hospital
Surat, Gujarat, India, 395001
Actively Recruiting
6
Unique Hospital Multispeciality and Research Institute
Surat, Gujarat, India, 395002
Actively Recruiting
7
Kiran Hospital Multi Super Speciality Hospital & Research Centre
Surat, Gujarat, India, 395004
Actively Recruiting
8
Pt.B.D Sharma PGIMS Rohtak
Rohtak, Haryana, India, 124001
Actively Recruiting
9
Sri Shankara Cancer Hospital and Research Centre
Bangalore, Karnataka, India, 560004
Active, Not Recruiting
10
Healthcare Global Enterprises Ltd
Bangalore, Karnataka, India, 560027
Actively Recruiting
11
Cytecare Hospitals Pvt. Ltd
Bangalore, Karnataka, India, 560064
Actively Recruiting
12
Vydehi Institute of Medical Sciences and Research Centre
Bangalore, Karnataka, India, 560066
Actively Recruiting
13
KLEs Dr. Prabhakar Kore Hospital & Medical Research Center
Bangalore, Karnataka, India, 590010
Actively Recruiting
14
K R Hospital
Mysore, Karnataka, India, 570001
Actively Recruiting
15
Krupamayi Hospital
Aurangabad, Maharashtra, India, 431001
Actively Recruiting
16
Kolhapur Cancer Centre
Kolhāpur, Maharashtra, India, 416234
Actively Recruiting
17
Kims-Kingsway Hospitals
Nagpur, Maharashtra, India, 440001
Actively Recruiting
18
Rhythm Heart And Critical Care
Nagpur, Maharashtra, India, 440012
Actively Recruiting
19
Treat Me Hospital
Nagpur, Maharashtra, India, 440015
Actively Recruiting
20
Soham Hospital
Nashik, Maharashtra, India, 422001
Actively Recruiting
21
HCG Manavata Cancer Centre
Nashik, Maharashtra, India, 422002
Actively Recruiting
22
Cancure Day Care Centre
Navi Mumbai, Maharashtra, India, 400703
Actively Recruiting
23
The Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Navi Mumbai, Maharashtra, India, 410210
Actively Recruiting
24
Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, India, 411001
Actively Recruiting
25
MMFHA Joshi Hospital
Pune, Maharashtra, India, 411004
Active, Not Recruiting
26
Novo Solitaire Care
Pune, Maharashtra, India, 411014
Actively Recruiting
27
Onco-Life Cancer Centre
Pune, Maharashtra, India, 530040
Actively Recruiting
28
Sunact Cancer Institute Pvt Ltd
Thane, Maharashtra, India, 400615
Actively Recruiting
29
Max Super Speciality Hospital
New Delhi, New Delhi, India, 110017
Actively Recruiting
30
All India Institute of Medical Sciences
New Delhi, New Delhi, India, 110029
Actively Recruiting
31
Sparsh Hospital & Critical care(P) LTD
Bhubaneswar, Odisha, India, 751007
Actively Recruiting
32
Jawaharlal Institute of postgraduate medical education and research
Puducherry, Puducherry, India, 605006
Actively Recruiting
33
Apollo Cancer Hospital
Hyderabad, Telangana, India, 500033
Actively Recruiting
34
Basavatarakam Indo American Cancer Hospital & Research Institute
Hyderabad, Telangana, India, 500034
Actively Recruiting
35
BP Poddar Hospital & Medical Research Ltd
Kolkata, West Bengal, India, 700053
Actively Recruiting
36
Tata Medical Center
Kolkata, West Bengal, India, 700160
Actively Recruiting
37
Chittaranjan National Cancer Institute
Kolkata, West Bengal, India, 9830115905
Actively Recruiting
Research Team
S
Suchit Kumbhare
CONTACT
S
Suresh Oduru
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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