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Tests treatment safety and results for Relapsed Malignant Solid Neoplasm
Official title A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)
ClinicalTrials.gov ID: NCT05865002
What this study is testing
What is AUR107?
AUR107 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for relapsed malignant solid neoplasm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Systemic anti-cancer therapy, such as chemotherapy, biological therapy, or immunomodulatory drug therapy, received within the past 28 days or 5...
- Presence of acute or chronic toxicity resulting from prior anticancer treatment, with the exception of alopecia or nail changes, that has not...
- Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the...
- Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
- Use of drugs which are moderate / strong CYP3A4 inducers and/or drugs which are predominantly metabolized by CYP3A4 within 1week or 5 half-lives...
- Note: This class of drugs are also prohibited during DLT evaluation period and must be either avoided or used with caution beyond DLT evaluation...
See the full eligibility 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
- 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).
- Ability to swallow and retain oral medications.
- Histopathological diagnosis of a solid tumor. Note: The solid tumors must be in Stage IV at screening.
- Evidence of measurable disease per RECIST, v1.1 for solid tumors.
- 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...
- 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...
- 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.
- 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 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.
- 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...
- Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia).
- Patients with leukemia, myelodysplastic syndrome, multiple myeloma, or lymphoma.
- 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...
- Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.
- Known 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...
- Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in the past 3 months, before Cycle 1 Day 1.
- QTc (Bazzett) interval \>460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose.
- 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...
- 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...
- Positive pregnancy test for women of childbearing 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 the male or female condom, spermicidal gel...
The study team makes the final eligibility decision.
Where it's taking place
- Vijayawada, Andhra Pradesh, India
- Visakhapatnam, Andhra Pradesh, India
- Chandigarh, Chandigarh, India
- Ahmedabad, Gujarat, India
- Surat, Gujarat, India
- Rohtak, Haryana, India
- Bangalore, Karnataka, India
- Mysore, Karnataka, India
- Aurangabad, Maharashtra, India
- Kolhāpur, Maharashtra, India
- Nagpur, Maharashtra, India
- Nashik, Maharashtra, India
- Navi Mumbai, Maharashtra, India
- Pune, Maharashtra, India
- Thane, Maharashtra, India
- New Delhi, New Delhi, India
- Bhubaneswar, Odisha, India
- Puducherry, Puducherry, India
- Hyderabad, Telangana, India
- Kolkata, West Bengal, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vijayawada, Andhra Pradesh, India; Visakhapatnam, Andhra Pradesh, India; Chandigarh, Chandigarh, India; Ahmedabad, Gujarat, India; Surat, Gujarat, India; Rohtak, Haryana, India and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.