Solid Tumor, AdultPhase 1SURYA-1NCT05605119
First in Human, Dose Escalation, Dose Expansion Study of AUR105
A Phase 1 study testing AUR105 in people with Solid Tumor, Adult and Non-hodgkin Lymphoma, run by Aurigene Discovery Technologies Limited at 9 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Solid Tumor, Adult, Non-hodgkin Lymphoma, Hodgkin Lymphoma
- What is being tested?
- AUR105
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 9 sitesIndia
- Study dates
- 30 Nov 2022to 1 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
India9 sites
IMS&SUM Hospital
Bhubaneswar, Bhubaneswar, 751003
Sparsh Hospital and Critical Care
Bhubaneswar, Odisha, 751007
All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019
Krupamayi Hospital
Chhatrapati Sambhajinagar, Maharashtra, 431001
ALL India Institute of medical Scieneces
New Delhi, New Delhi, 110029
Moraya Multi-Speciality Hospital
Pune, Maharasthra, 411033
Kailash Cancer Hospital and Research Centre
Vadodara, Gujarat, 391760
HCG City Cancer Center
Vijayawada, Andhra Pradesh, 520002
Omega Hospitals
Visakhapatnam, Andhra Pradesh, 530040
About this study
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)
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.
Read the 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
- Conditions
- Solid Tumor, Adult, Non-hodgkin Lymphoma, Hodgkin Lymphoma
- Being tested
- AUR105
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUR105Drug
Once daily
| Study group | Role | What they receive |
|---|---|---|
| AUR105 50mg to 750mg | Experimental | Currently planned dose levels in Part 1 are 50mg, 100mg, 200mg, 300mg, 450mg, 600mg and 740mg once daily Receives: Drug: AUR105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoints
First cycle DLT
Measured: 28 Days
Primary Endpoints
PK parameters - Cmax
Measured: Day 16
Primary Endpoints
PK parameters- AUC
Measured: Day 16
Primary Endpoints
PK parameters- Tmax
Measured: Day 16
Primary Endpoints
Recommended Phase 2 Dose determination
Measured: Through study completion, an average of 1 year
Secondary outcomes (7)
Exploratory Endpoints:
PD biomarkers (SDMA)
Measured: Day 15
Exploratory Endpoints:
Efficacy assessments overall response rate
Measured: Through study completion, an average of 1 year
Exploratory Endpoints:
Efficacy assessments- duration of response
Measured: Through study completion, an average of 1 year
Exploratory Endpoints:
Efficacy assessments- PFS
Measured: Through study completion, an average of 1 year
Exploratory Endpoints:
Change in Tumor Specific Markers - CA-125 in ovarian cancer
Measured: Through study completion, an average of 1 year
Exploratory Endpoints:
Change in Tumor Specific Markers - PSA in Castrate Resistant Prostate Cancer
Measured: Through study completion, an average of 1 year
Exploratory Endpoints:
Change in Tumor Specific Markers - CEA in colorectal cancer
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start30 Nov 2022
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Why it stopped: Patient recruitment problems.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Dose Escalation "3+3" dose escalation
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurigene Discovery Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605119
- Sponsor's protocol ID
- AUR105-101
- Other IDs
- CTRI/2022/09/046061
- Acronym
- SURYA-1
- Status last verified
- Jan 2024
- First submitted
- 5 Oct 2022
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05605119
- Acronym / sponsor ID
- SURYA-1 / AUR105-101
- Conditions
- Solid Tumor, Adult, Non-hodgkin Lymphoma, Hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient recruitment problems.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Aurigene Discovery Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose Escalation "3+3" dose escalation
| Arm | Type | Receives |
|---|---|---|
| AUR105 50mg to 750mg | Experimental | Drug: AUR105Currently planned dose levels in Part 1 are 50mg, 100mg, 200mg, 300mg, 450mg, 600mg and 740mg once daily |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AUR105Once daily | Drug | AUR105 50mg to 750mg |
Primary outcome
Primary Endpoints
Time frame: 28 Days
First cycle DLT
Primary Endpoints
Time frame: Day 16
PK parameters - Cmax
Primary Endpoints
Time frame: Day 16
PK parameters- AUC
Primary Endpoints
Time frame: Day 16
PK parameters- Tmax
Primary Endpoints
Time frame: Through study completion, an average of 1 year
Recommended Phase 2 Dose determination
7 secondary outcomes
Exploratory Endpoints:
Time frame: Day 15
Exploratory Endpoints:
Time frame: Through study completion, an average of 1 year
Exploratory Endpoints:
Time frame: Through study completion, an average of 1 year
Exploratory Endpoints:
Time frame: Through study completion, an average of 1 year
Exploratory Endpoints:
Time frame: Through study completion, an average of 1 year
Exploratory Endpoints:
Time frame: Through study completion, an average of 1 year
Exploratory Endpoints:
Time frame: Through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Patient recruitment problems.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AUR105 in people with Solid Tumor, Adult and Non-hodgkin Lymphoma, run by Aurigene Discovery Technologies Limited at 9 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Patient recruitment problems.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoints (time frame: 28 Days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.