A Phase 1 Clinical Trial of AUR106 in Patients With Relapsed Advanced Malignancies

NCT05861947 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: AUR106-101
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 6

Brief Summary

A Phase I, Open Label, Dose-Escalation, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR106 in Patients with Select Relapsed Advanced Malignancies (JIVAN).

Conditions

Relapse; Advanced Malignant Neoplasm; Gastric Cancer; Urothelial Carcinoma; Kidney Cancer; Colon Cancer; Esophagus Cancer; Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (6)

• Optimal Biological Dose (OBD)

  To determine the Optimal Biological Dose (OBD) based on safety, pharmacokinetic, and pharmacodynamic data

  First 28 Days (Cycle 1)

• Dose Limiting Toxicity (DLT)

  To determine the DLT of AUR106

  First 28 Days (Cycle 1)

• Pharmacokinetics: Area under the curve (AUC)

  Area under the curve of AUR106

  Day 1 and Day 15

• Pharmacokinetics: Maximum concentration Pharmacokinetics: Maximum concentration

  Maximum concentration of AUR106

  Day 1 and Day 15

• Pharmacokinetics: Time to Maximum concentration

  Time to Maximum concentration of AUR106

  Day 1 and Day 15

• Pharmacokinetics: Terminal elimination half life

  Terminal elimination half life of AUR106

  Day 1 and Day 15

Secondary Outcomes (2)

• Adverse Events

  Through study completion, an average of 1 year

• Laboratory abnormalities

  Through study completion, an average of 1 year

Other Outcomes (7)

• Exploratory endpoint (PD biomarker): CD3 level

  Day 1, Day 8 and Day 15

• Exploratory endpoint (PD biomarker): CD4 level

  Day 1, Day 8 and Day 15

• Exploratory endpoint (PD biomarker): CD8 level

  Day 1, Day 8 and Day 15

Study Arms (1)

AUR106

EXPERIMENTAL

25mg to 100 mg, Currently planned dose levels are 25 mg QD, 50 mg QD, 25 mg BID, 50 mg BID, 100 mg BID

Drug: AUR106

Interventions

AUR106 DRUG

Once or twice daily

AUR106

Eligibility Criteria

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

You may qualify if:

• Provide signed and dated informed consent and agree to comply with all study related activities.
• Male or female patients aged ≥ 18 years.
• Patients have to meet the following criteria:
• Pathological diagnosis of the following solid tumors: Non-small cell lung cancer, Gastric cancer, Urothelial cancer (includes bladder cancer and cancers of ureter / renal pelvis), Kidney cancer, Colon cancer, Esophageal cancer).
• Standard curative or life prolonging measures do not exist, and patient must have exhausted all effective therapies, available locally. At a minimum, patients should have received at least 2 lines of therapy in the metastatic setting.
• Standard treatment options provided to the patients are exhausted.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Patients with disease related ECOG 2 are allowed, in addition to ECOG 0 and 1).
• Acceptable bone marrow 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).
• Acceptable organ function as described below:
• 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).

You may not qualify if:

• 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 the Cycle 1 Day 1 of the study.
• Presence of an acute or chronic toxicity resulting from prior anti-cancer 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.
• Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) metastases. Patients with previously treated (\> 6 months of screening) 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).
• Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.
• Known active or chronic hepatitis B or hepatitis C infection.
• Uncontrolled congestive heart failure (New York Heart Association \[NYHA\] Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, 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.
• The QTcF (corrected QT interval Fridericia method) value in the screening ECG \> 460 ms in both males and females.
• Previous or concomitant additional malignancy, except for basal-cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix; patients with other malignancies are eligible if they have remained disease free for at least 2 years prior to trial entry and in the opinion of the investigator deemed to have a low likelihood of recurrence.
• Pregnant or lactating women.
• Any clinically significant medical, psychiatric or social condition; or laboratory abnormality that may increase the risk of trial participation or may interfere with the informed consent process and/or with compliance with the requirements of the trial or may interfere with the interpretation of the trial results and, in the Investigator's opinion, would make the patient inappropriate for entry into this trial.
• Patients who require concomitant administration of drugs which have a high risk of prolonging QT interval.

Sponsors & Collaborators

• Aurigene Discovery Technologies Limited: lead

Study Sites (6)

Omega Hospital

Visakhapatnam, Andhra Pradesh, 530040, India

Location

Unique Hospital Multispeciality and Research Institute

Surat, Gujarat, 395002, India

Location

Kiran Multi Super Specialty Hospital

Surat, Gujarat, 395004, India

Location

Sankalp Speciality Hospital

Nashik, Maharashtra, 422009, India

Location

Moraya Multispeciality Hospital (Ashwin Medical Foundations)

Pune, Maharasthra, 411033, India

Location

All India Institute of Medical Sciences

Bhubaneswar, Odisha, 751019, India

Location

MeSH Terms

Conditions

Recurrence; Carcinoma, Non-Small-Cell Lung; Stomach Neoplasms; Carcinoma, Transitional Cell; Kidney Neoplasms; Colonic Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases

Study Officials

• Akhil Kumar, MD

  Head Clinical Development

  STUDY DIRECTOR

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" Design

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 17, 2023
• Study Start: August 26, 2023
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: April 17, 2026

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (6)