First in Human, Dose Escalation, Dose Expansion Study of AUR105

Last updated: January 29, 2024
Sponsor: Aurigene Discovery Technologies Limited
Overall Status: Active - Recruiting

Phase

1

Condition

Non-hodgkin's Lymphoma

Hematologic Cancer

Lymphoma

Treatment

AUR105

Clinical Study ID

NCT05605119
AUR105-101
CTRI/2022/09/046061
  • Ages 18-99
  • All Genders

Study Summary

This is a multi-center, open-label, First in Human, Phase 1 study of AUR 105 in adult patients with advanced malignancies.

The study will have two parts: a Dose Escalation Part and Dose Expansion Part.

Eligibility Criteria

Inclusion

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 withouttransfusion 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 xULN; (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 xULN) 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 orestimated by the Cockcroft-Gault formula). (Cockcroft-Gault formula for estimatedcreatinine 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 HodgkinLymphoma
  • Evidence of measurable disease per RECIST, v1.1 for solid tumors (Eisenhauer et al.
  1. and per Lugano Criteria for Lymphoma (Cheson et al. 2014).
  • Standard curative measures do not exist, and patient must have exhausted all effectivetherapies, available locally.
  1. At a minimum, solid tumor patients must have received at least two lines ofsystemic therapies in the metastatic incurable settings(these two lines must bein 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 ofsystemic therapies. These systemic therapies could be either in the stage II, IIIor IV.

Exclusion

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, asdetermined by NCI CTCAE v 5.0
  • Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited fieldpalliative radiation is allowed and no restrictions during the screening period orduring 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-gpinhibitor/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) centralnervous system (CNS) metastases or CNS lymphoma. Patients with previously treated (> 6months of screening) CNS metastases or CNS lymphoma and are now stable andasymptomatic, from CNS perspective, are allowed
  • Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedurerequiring general anesthesia)
  • Patients with leukemia or myelodysplastic syndrome or multiple myeloma
  • Active infection requiring systemic therapy.
    1. Prophylactic use of antibiotics is allowed.
  • Any infection detected during screening period which is resolved adequately accordingto investigator before the Cycle 1 Day 1, is allowed.
  • Known to be human immunodeficiency virus (HIV) positive or have an acquiredimmunodeficiency 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 ortargeted therapy while on study.
  • Uncontrolled congestive heart failure (New York Heart Association [NYHA] Class 2-4),angina, myocardial infarction, cerebrovascular accident, coronary/peripheral arterybypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3months prior to Cycle 1 Day 1
  • Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiacdysrhythmias in past 3 months, before Cycle 1 Day 1
  • QTc (Bazzett) interval >450 ms for male patients or >460 ms for female patients on ECGat screening and/or at Cycle 1 Day 1 predose.
  • Uncontrolled intercurrent illness including, but not limited to, symptomaticcongestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiacarrhythmia, active peptic ulcer disease or significant gastritis, active bleedingdiatheses, presence
  • Current swab-positive or suspected (under investigation) Covid19 infection or feverand other signs or symptoms suggestive of Covid-19 infection with recent contact ofperson(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 cancerof the cervix in situ and the disease under study.
  • Positive pregnancy test for women of child-bearing potential (WOCBP) at the screeningor enrolment visit
  • Lactating women or WOCBP who are neither surgically sterilized nor willing to usereliable contraceptive methods (hormonal contraceptive, IUD, or any double combinationof male or female condom, spermicidal gel, diaphragm, sponge, cervical cap)

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: AUR105
Phase: 1
Study Start date:
November 30, 2022
Estimated Completion Date:
May 30, 2026

Study Description

This is a Phase I, Open label First in Human Study in adult patients with relapsed advanced malignancies.

The study will have two parts. Dose escalation part and Dose expansion part

Connect with a study center

  • HCG City Cancer Center

    Vijayawada, Andhra Pradesh 520002
    India

    Active - Recruiting

  • Omega Hospitals

    Visakhapatnam, Andhra Pradesh 530040
    India

    Active - Recruiting

  • Kailash Cancer Hospital and Research Centre

    Vadodara, Gujarat 391760
    India

    Active - Recruiting

  • Moraya Multi-Speciality Hospital

    Pune, Maharasthra 411033
    India

    Active - Recruiting

  • Krupamayi Hospital

    Aurangabad, Maharastra 431001
    India

    Active - Recruiting

  • All India Institute of Medical Sciences

    Bhubaneswar, Odisha 751019
    India

    Active - Recruiting

  • Sparsh Hospital and Critical Care

    Bhubaneswar, Odisha 751007
    India

    Active - Recruiting

  • IMS&SUM Hospital

    Bhubaneswar, 751003
    India

    Active - Recruiting

  • ALL India Institute of medical Scieneces

    New Delhi, 110029
    India

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.