Ovarian CancerPhase 2TEJAS-2NCT06760702
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AUR 109 in Patients With Colorectal, Ovarian, and Renal Cancers
A Phase 2 study testing AUR109 200mg, AUR109 300mg and AUR109 400mg in people with Ovarian Cancer and Colorectal Cancer, run by Aurigene Discovery Technologies Limited at 5 sites in India.
Trial summary
This is an open-label, multicentre, randomized, Phase II study and will be conducted with co-primary objectives of the study are to assess the efficacy of AUR109, as measured by ORR and safety / tolerability at three different dose levels of the study drug in three cancer indications i.e., colorectal, ovarian cancer… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ovarian Cancer, Colorectal Cancer, Renal Cancer
- What is being tested?
- AUR109 200mg, AUR109 300mg and AUR109 400mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 5 sitesIndia
- Study dates
- 9 Nov 2024to 1 Feb 2026
- Phase
- Phase 2
- 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
- Provide signed and dated informed consent and agree to comply with all study related activities.
- Male or female patients aged ≥ 18 years.
- Pathological diagnosis of adenocarcinoma of colorectal origin, epithelial ovarian cancer (ovarian cancer term also includes fallopian tube cancer as well as primary peritoneal cancer), or renal cell carcinoma of the kidney.
- Patients must have received at least two lines of systemic therapy and should have exhausted all available local therapies. At a minimum, for each of the respective cancer types, patients should have received the following:
- Colorectal Cancer - Previous treatment should include 5-FU based treatments, oxaliplatin based treatments, irinotecan-based treatments, IV VEGF inhibitors, IV EGFR antibodies (for KRAS wildtype), PD-1 antibodies for known MSI-H positive tumors, regorafenib and lonsurf, anti-HER2 agents (e.g., FDA approved Tucatinib and Trastuzumab combination, where available) for HER2 amplified colorectal cancer, unless any of these are not available locally or prohibitive for the patient financially or if the patient is not eligible for these or if the patient has refused these.
- Ovarian cancer (also includes fallopian tube cancer and primary peritoneal cancer) - Tumor must be platinum refractory, defined as treatment free interval of \< 6 months from the last platinum-based regimen. In addition, patient should have received topotecan, gemcitabine, liposomal doxorubicin, bevacizumab and PARP inhibitors (for BRCA mutants), mirvetuximab for folate receptor alpha amplified ovarian cancer, unless any of these are not available locally or prohibitive for the patient financially or if the patient is not eligible for these or if the patient has refused these.
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- Renal Cell Carcinoma - Patient should have received an oral VEGF inhibitor and PD-1/PD-L1 inhibitors, unless any of these are not available locally or prohibitive for the patient financially or if the patient is not eligible for these or if the patient has refused these.
- 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 function as described below:
- ANC ≥ 1200/μL (without WBC growth factor support) Platelet count ≥ 90,000/μL without transfusion support Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)
- Acceptable organ function as described below:
- Total Bilirubin ≤ 1.2 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) ≥ 30 mL/min (either measured or estimated by the Cockcroft- Gault formula) [Cockcroft-Gault formula for estimated creatinine clearance (eCrCl) = (140 - Age) × Weight (kg) × (0.85 if Female) / (72 × serum creatinine (mg/dL))] Albumin ≥ 3.0 g/dL
- Ability to swallow and retain oral medications.
- Negative serum pregnancy test in women of childbearing potential (WOCBP).
- Women of childbearing potential and men who partner with such a woman of childbearing potential must agree to use one or more of highly effective method(s) for contraception for the duration of the study, i.e., through 28-day follow up visit, after discontinuation of study drug(s).
- Evidence of measurable disease per RECIST, v1.1 for solid tumors. Measurable disease for solid tumors is defined as at least one lesion that can be accurately measured in at least 1 dimension with a minimum size of 10 mm for non-nodal lesions or 15 mm in short axis for nodal lesions.
Who cannot join
- Patients without any wild type allele (Such as *28/*28, *37/*37 or *37/*28 variants) genotypes for UGT1A1.
- 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.
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- 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, or transient ischemic attack, or pulmonary embolism within 3 months prior to Cycle 1 Day 1.
- Left Ventricular Ejection Fraction (LVEF) \< 50% at screening.
- 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.
- Availability of any therapeutic options approved locally.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Sujan Surgical Cancer Hospital and Amravati Cancer Foundation
Amravati, Maharashtra, 444605
Uro-Science Centre, S.P. Medical College & AG of Hospitals
Bikaner, Rajasthan, 334003
Gindodi Devi Hospital
Khursīpār, Chhattisgarh, 490012
Kiran Multi Super Speciality Hospital and Research Centre
Surat, Gujarat, 395004
Sunshine Global Hospitals
Surat, Gujarat, 395007
About this study
Official title: A Phase II, Open-label, Randomized, Dose-ranging Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AUR 109 in Patients With Colorectal, Ovarian, and Renal Cancers (TEJAS-2)
This is an open-label, multicentre, randomized, Phase II study and will be conducted with co-primary objectives of the study are to assess the efficacy of AUR109, as measured by ORR and safety / tolerability at three different dose levels of the study drug in three cancer indications i.e., colorectal, ovarian cancer and renal cancer.
Read the detailed description
This is a Phase II, open-label, multicenter study evaluating the efficacy and safety of the drug AUR109 at three different dose levels (200 mg, 300 mg, and 400 mg) in patients with colorectal, ovarian, or renal cancer. Participants must have undergone at least two lines of systemic therapy and exhausted all local treatment options. The 200 mg and 300 mg doses will be administered continuously over a 21-day cycle, while the 400 mg dose will follow an interrupted regimen (2 weeks on, 1 week off). The drug is to be taken once daily according to the specified dosing schedule.
- Conditions
- Ovarian Cancer, Colorectal Cancer, Renal Cancer
- Being tested
- AUR109 200mg, AUR109 300mg, AUR109 400mg
- Keywords
- Colorectal cancer, Ovarian cancer, Renal cancer
- Medical subject headings
- Ovarian Neoplasms, Colorectal Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUR109 200mgDrug
AUR109 200mg (once daily)
AUR109 300mgDrug
AUR109 300mg once daily
AUR109 400mgDrug
AUR109 400mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer | Experimental | Not described Receives: Drug: AUR109 200mg; Drug: AUR109 300mg; Drug: AUR109 400mg |
| Ovarian Cancer | Experimental | Not described Receives: Drug: AUR109 200mg; Drug: AUR109 300mg; Drug: AUR109 400mg |
| Renal Cancer | Experimental | Not described Receives: Drug: AUR109 200mg; Drug: AUR109 300mg; Drug: AUR109 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Efficacy
To assess the safety and efficacy of three dose levels of AUR109 (200 mg, 300 mg, and 400 mg) in patients with colorectal, ovarian, and renal cancers, as measured by Objective Tumor Response Rate (ORR) (CR + PR).
Measured: Baseline, Cycle 2 Day 1,Cycle 4 Day 1,Cycle 6 Day1,Cycle 8 Day 1 and Cycle 10 Day 1 (each cycle is 21 days)
Secondary outcomes (4)
Pharmacokinetic Profile (Cmax)
Maximum concentration of AUR109
Measured: Day 1 and Day 15
Pharmacokinetic Profile (Tmax)
Tmax in hours
Measured: Day 1 and Day 15
Pharmacokinetic Profile (AUC)
Area under the curve of AUR109 in ng/ml
Measured: Day 1 and Day 15
HRQoL
FACT-G (Functional Assessment of Cancer Therapy - General) Score (scalle range is 0 (Lowest) to 4 (Highest)
Measured: Assessment will be performed at 3 rd week (Day 15 to 21) of every 3 cycles (21 days per Cycle) until either progressive disease or intolerable toxicity occurs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start9 Nov 2024
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
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 Ovarian CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three Dose regimens of 200 mg, 300 mg and 400 mg with 10 patients in each dose arm, are applied to three different indications.
- Masking
- None (open label)
- Enrolment
- 29 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
- NCT06760702
- Sponsor's protocol ID
- AUR109-202
- Acronym
- TEJAS-2
- Status last verified
- Dec 2024
- First submitted
- 7 Nov 2024
- 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 II, Open-label, Randomized, Dose-ranging Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AUR 109 in Patients With Colorectal, Ovarian, and Renal Cancers (TEJAS-2)
- ClinicalTrials.gov ID
- NCT06760702
- Acronym / sponsor ID
- TEJAS-2 / AUR109-202
- Conditions
- Ovarian Cancer, Colorectal Cancer, Renal Cancer
- Keywords
- Colorectal cancer, Ovarian cancer, Renal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient recruitment problems.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Aurigene Discovery Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2024 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 7 Jan 2025 (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 an open-label, multicentre, randomized, Phase II study and will be conducted with co-primary objectives of the study are to assess the efficacy of AUR109, as measured by ORR and safety / tolerability at three different dose levels of the study drug in three cancer indications i.e., colorectal, ovarian cancer and renal cancer.
Detailed description
This is a Phase II, open-label, multicenter study evaluating the efficacy and safety of the drug AUR109 at three different dose levels (200 mg, 300 mg, and 400 mg) in patients with colorectal, ovarian, or renal cancer. Participants must have undergone at least two lines of systemic therapy and exhausted all local treatment options. The 200 mg and 300 mg doses will be administered continuously over a 21-day cycle, while the 400 mg dose will follow an interrupted regimen (2 weeks on, 1 week off). The drug is to be taken once daily according to the specified dosing schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three Dose regimens of 200 mg, 300 mg and 400 mg with 10 patients in each dose arm, are applied to three different indications.
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer | Experimental | Drug: AUR109 200mg, Drug: AUR109 300mg, Drug: AUR109 400mg |
| Ovarian Cancer | Experimental | Drug: AUR109 200mg, Drug: AUR109 300mg, Drug: AUR109 400mg |
| Renal Cancer | Experimental | Drug: AUR109 200mg, Drug: AUR109 300mg, Drug: AUR109 400mg |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Provide signed and dated informed consent and agree to comply with all study related activities.
- Male or female patients aged ≥ 18 years.
- Pathological diagnosis of adenocarcinoma of colorectal origin, epithelial ovarian cancer (ovarian cancer term also includes fallopian tube cancer as well as primary peritoneal cancer), or renal cell carcinoma of the kidney.
- Patients must have received at least two lines of systemic therapy and should have exhausted all available local therapies. At a minimum, for each of the respective cancer types, patients should have received the following:
- Colorectal Cancer - Previous treatment should include 5-FU based treatments, oxaliplatin based treatments, irinotecan-based treatments, IV VEGF inhibitors, IV EGFR antibodies (for KRAS wildtype), PD-1 antibodies for known MSI-H positive tumors, regorafenib and lonsurf, anti-HER2 agents (e.g., FDA approved Tucatinib and Trastuzumab combination, where available) for HER2 amplified colorectal cancer, unless any of these are not available locally or prohibitive for the patient financially or if the patient is not eligible for these or if the patient has refused these.
Key exclusion criteria (18 listed)
- Patients without any wild type allele (Such as *28/*28, *37/*37 or *37/*28 variants) genotypes for UGT1A1.
- 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.
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 |
|---|---|---|
| AUR109 200mgAUR109 200mg (once daily) | Drug | Colorectal cancer, Ovarian Cancer, Renal Cancer |
| AUR109 300mgAUR109 300mg once daily | Drug | Colorectal cancer, Ovarian Cancer, Renal Cancer |
| AUR109 400mgAUR109 400mg once daily | Drug | Colorectal cancer, Ovarian Cancer, Renal Cancer |
Primary outcome
Safety and Efficacy
Time frame: Baseline, Cycle 2 Day 1,Cycle 4 Day 1,Cycle 6 Day1,Cycle 8 Day 1 and Cycle 10 Day 1 (each cycle is 21 days)
To assess the safety and efficacy of three dose levels of AUR109 (200 mg, 300 mg, and 400 mg) in patients with colorectal, ovarian, and renal cancers, as measured by Objective Tumor Response Rate (ORR) (CR + PR).
4 secondary outcomes
Pharmacokinetic Profile (Cmax)
Time frame: Day 1 and Day 15
Pharmacokinetic Profile (Tmax)
Time frame: Day 1 and Day 15
Pharmacokinetic Profile (AUC)
Time frame: Day 1 and Day 15
HRQoL
Time frame: Assessment will be performed at 3 rd week (Day 15 to 21) of every 3 cycles (21 days per Cycle) until either progressive disease or intolerable toxicity occurs
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AUR109 200mg, AUR109 300mg and AUR109 400mg in people with Ovarian Cancer and Colorectal Cancer, run by Aurigene Discovery Technologies Limited at 5 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 16 inclusion and 18 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 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety and Efficacy (time frame: Baseline, Cycle 2 Day 1,Cycle 4 Day 1,Cycle 6 Day1,Cycle 8 Day 1 and Cycle 10 Day 1 (each cycle is 21 days)). 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.