SURYA-1: First in Human, Dose Escalation, Dose Expansion Study of AUR105

• Sponsor: Aurigene Discovery Technologies Limited (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05605119
• Collaborator: (none)
• Enrollment: 40
• Locations: 7
• Arm: 1
• Anticipated Duration (Months): 42
• Patients Per Site: 5.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor, Adult; Non-hodgkin Lymphoma; Hodgkin Lymphoma	Drug: AUR105	Phase 1

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Intervention Model Description: Dose Escalation "3+3" dose escalationDose Escalation "3+3" dose escalation
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: Nov 30, 2022
• Anticipated Primary Completion Date: Dec 30, 2025
• Anticipated Study Completion Date: May 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AUR105 50mg to 750mg Currently planned dose levels in Part 1 are 50mg, 100mg, 200mg, 300mg, 450mg, 600mg and 740mg once daily	Drug: AUR105; Once daily

Outcome Measures

Primary Outcome Measures

1. Primary Endpoints [28 Days]

   First cycle DLT

2. Primary Endpoints [Day 16]

   PK parameters - Cmax

3. Primary Endpoints [Day 16]

   PK parameters- AUC

4. Primary Endpoints [Day 16]

   PK parameters- Tmax

5. Primary Endpoints [Through study completion, an average of 1 year]

   Recommended Phase 2 Dose determination

Secondary Outcome Measures

1. Exploratory Endpoints: [Day 15]

   PD biomarkers (SDMA)

2. Exploratory Endpoints: [Through study completion, an average of 1 year]

   Efficacy assessments overall response rate

3. Exploratory Endpoints: [Through study completion, an average of 1 year]

   Efficacy assessments- duration of response

4. Exploratory Endpoints: [Through study completion, an average of 1 year]

   Efficacy assessments- PFS

5. Exploratory Endpoints: [Through study completion, an average of 1 year]

   Change in Tumor Specific Markers - CA-125 in ovarian cancer

6. Exploratory Endpoints: [Through study completion, an average of 1 year]

   Change in Tumor Specific Markers - PSA in Castrate Resistant Prostate Cancer

7. Exploratory Endpoints: [Through study completion, an average of 1 year]

   Change in Tumor Specific Markers - CEA in colorectal cancer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. 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.

• 1. 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kailash Cancer Hospital and Research Centre	Vadodara	Gujarat	India	391760
2	Moraya Multi-Speciality Hospital	Pune	Maharasthra	India	411033
3	Krupamayi Hospital	Aurangabad	Maharastra	India	431001
4	Sparsh Hospital and Critical Care	Bhubaneswar	Odisha	India	751007
5	All India Institute of Medical Sciences	Bhubaneswar	Odisha	India	751019
6	IMS&SUM Hospital	Bhubaneswar		India	751003
7	ALL India Institute of medical Scieneces	New Delhi		India	110029

Sponsors and Collaborators

• Aurigene Discovery Technologies Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aurigene Discovery Technologies Limited
• ClinicalTrials.gov Identifier: NCT05605119
• Other Study ID Numbers: AUR105-101; CTRI/2022/09/046061
• First Posted: Nov 4, 2022
• Last Update Posted: Dec 15, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma

Study Results

No Results Posted as of Dec 15, 2022