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)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 and renal cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
India
Sujan Surgical Cancer Hospital and Amravati Cancer Foundation
RECRUITING
Amravati
Uro-Science Centre, S.P. Medical College & AG of Hospitals
RECRUITING
Bikaner
Gindodi Devi Hospital
RECRUITING
Khursīpār
Kiran Multi Super Speciality Hospital and Research Centre
RECRUITING
Surat
Sunshine Global Hospitals
RECRUITING
Surat
Contact Information
Primary
Akhil Kumar
akhil_k@aurigene.com
9632203510
Time Frame
Start Date: 2024-11-09
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 90
Treatments
Experimental: Colorectal cancer
Experimental: Ovarian Cancer
Experimental: Renal Cancer
Sponsors
Leads: Aurigene Discovery Technologies Limited

This content was sourced from clinicaltrials.gov

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