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Evaluating AUR107 for advanced relapsed cancers

A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter, First in Human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Oral AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)

PHASE1 · Aurigene Discovery Technologies Limited · NCT05865002

This study is testing a new drug called AUR107 to see if it is safe and effective for adults with advanced cancers that have not responded to other treatments.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment50 (estimated)
Ages18 Years and up
SexAll
SponsorAurigene Discovery Technologies Limited (industry)
Drugs / interventionschemotherapy, radiation, prednisone
Locations37 sites (Vijayawada, Andhra Pradesh and 36 other locations)
Trial IDNCT05865002 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AUR107 in adult patients with relapsed advanced malignancies. The trial will utilize a traditional 3+3 dose-escalation design to determine the optimal biological dose of AUR107 as a single agent. Participants will include those with advanced solid tumors such as non-small cell lung cancer, gastric cancer, and colon cancer, who have exhausted all available treatment options. The study will focus on patients with Stage IV solid tumors and measurable disease.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed advanced solid tumors who have no available curative or life-prolonging treatment options.

Not a fit: Patients with early-stage tumors or those who have not exhausted all available treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced malignancies that currently have no effective therapies.

How similar studies have performed: While this approach is novel for AUR107, similar studies evaluating new treatments for advanced malignancies have shown promise in the past.

Eligibility criteria

Show full inclusion / exclusion 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).

Where this trial is running

Vijayawada, Andhra Pradesh and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Relapsed Malignant Solid Neoplasm, Relapse malignant neoplasm, Non small cell lung cancer, Gastric cancer, Colon cancer, Esophageal cancer, Kidney cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.