Testing AUR105 in adults with advanced cancers

A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR105 in Patients With Relapsed Advanced Malignancies (SURYA-1)

This study is testing a new drug called AUR105 in adults with advanced cancers to see how much of it is safe to take and if it helps improve their condition.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Aurigene Discovery Technologies Limited (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 9 sites (Vijayawada, Andhra Pradesh and 8 other locations)
• Trial ID: NCT05605119 on ClinicalTrials.gov

What this trial studies

This is a multi-center, open-label Phase 1 study evaluating AUR105 in adult patients with advanced malignancies, including solid tumors and lymphomas. The study consists of two parts: a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase to further assess the safety and efficacy of the drug. Participants will be closely monitored for side effects and treatment response throughout the trial. The goal is to establish a safe dosage and gather preliminary data on the drug's effectiveness.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with relapsed advanced solid tumors or lymphomas and acceptable organ function.

Not a fit: Patients with severe organ dysfunction or those who cannot tolerate oral medications 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 cancers that are difficult to treat.

How similar studies have performed: Other studies involving first-in-human trials for similar advanced malignancies have shown promise, but this specific approach with AUR105 is novel.

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)

Where this trial is running

Vijayawada, Andhra Pradesh and 8 other locations

• HCG City Cancer Center — Vijayawada, Andhra Pradesh, India (Recruiting)
• Omega Hospitals — Visakhapatnam, Andhra Pradesh, India (Recruiting)
• Kailash Cancer Hospital and Research Centre — Vadodara, Gujarat, India (Recruiting)
• Moraya Multi-Speciality Hospital — Pune, Maharasthra, India (Recruiting)
• Krupamayi Hospital — Aurangabad, Maharastra, India (Recruiting)
• Sparsh Hospital and Critical Care — Bhubaneswar, Odisha, India (Recruiting)
• All India Institute of Medical Sciences — Bhubaneswar, Odisha, India (Recruiting)
• IMS&SUM Hospital — Bhubaneswar, India (Recruiting)
• ALL India Institute of medical Scieneces — New Delhi, India (Recruiting)

Study contacts

• Study coordinator: Divyesh Dr Mandavia

Conditions Solid Tumor, Adult; Non-hodgkin Lymphoma; Hodgkin Lymphoma