Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AUR 109 in Patients with Colorectal, Ovarian, and Renal Cancers

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)

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AUR 109 in Patients with Colorectal, Ovarian, and Renal Cancers (NCT06760702) is a Phase 2 interventional studying Ovarian Cancer and Colorectal Cancer, sponsored by Aurigene Discovery Technologies Limited. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Ovarian Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 90 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Ovarian Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Provide signed and dated willing to sign a consent form 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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. 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. Exclusion Criteria: * 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. * 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.

Treatments Being Tested

DRUG

AUR109 200mg

AUR109 200mg (once daily)

DRUG

AUR109 300mg

AUR109 300mg once daily

DRUG

AUR109 400mg

AUR109 400mg once daily

Locations (5)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Gindodi Devi Hospital
Khursīpār, Chhattisgarh, India
Kiran Multi Super Speciality Hospital and Research Centre
Surat, Gujarat, India
Sunshine Global Hospitals
Surat, Gujarat, India
Sujan Surgical Cancer Hospital and Amravati Cancer Foundation
Amravati, Maharashtra, India
Uro-Science Centre, S.P. Medical College & AG of Hospitals
Bikaner, Rajasthan, India

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06760702), the sponsor (Aurigene Discovery Technologies Limited), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06760702 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06760702?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06760702?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06760702. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06760702. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.