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

NCT05605119 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: AUR105-101CTRI/2022/09/046061
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Primary Endpoints

  First cycle DLT

  28 Days

• Primary Endpoints

  PK parameters - Cmax

  Day 16

• Primary Endpoints

  PK parameters- AUC

  Day 16

• Primary Endpoints

  PK parameters- Tmax

  Day 16

• Primary Endpoints

  Recommended Phase 2 Dose determination

  Through study completion, an average of 1 year

Secondary Outcomes (7)

• Exploratory Endpoints:

  Day 15

• Exploratory Endpoints:

  Through study completion, an average of 1 year

• Exploratory Endpoints:

  Through study completion, an average of 1 year

• Exploratory Endpoints:

  Through study completion, an average of 1 year

• Exploratory Endpoints:

  Through study completion, an average of 1 year

Study Arms (1)

AUR105 50mg to 750mg

EXPERIMENTAL

Currently planned dose levels in Part 1 are 50mg, 100mg, 200mg, 300mg, 450mg, 600mg and 740mg once daily

Drug: AUR105

Interventions

AUR105 DRUG

Once daily

AUR105 50mg to 750mg

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 (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.
• 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).
• 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.

You may not qualify if:

• 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.
• \. 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

Sponsors & Collaborators

• Aurigene Discovery Technologies Limited: lead

Study Sites (9)

HCG City Cancer Center

Vijayawada, Andhra Pradesh, 520002, India

Location

Omega Hospitals

Visakhapatnam, Andhra Pradesh, 530040, India

Location

IMS&SUM Hospital

Bhubaneswar, Bhubaneswar, 751003, India

Location

Kailash Cancer Hospital and Research Centre

Vadodara, Gujarat, 391760, India

Location

Krupamayi Hospital

Aurangabad, Maharashtra, 431001, India

Location

Moraya Multi-Speciality Hospital

Pune, Maharasthra, 411033, India

Location

ALL India Institute of medical Scieneces

New Delhi, New Delhi, 110029, India

Location

Sparsh Hospital and Critical Care

Bhubaneswar, Odisha, 751007, India

Location

All India Institute of Medical Sciences

Bhubaneswar, Odisha, 751019, India

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose Escalation "3+3" dose escalation

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: November 4, 2022
• Study Start: November 30, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 17, 2026

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (9)