OncoMatch/Clinical Trials/NCT06760702
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AUR 109 in Patients with Colorectal, Ovarian, and Renal Cancers
Is NCT06760702 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including AUR109 200mg and AUR109 300mg for ovarian cancer.
Treatment: AUR109 200mg · AUR109 300mg · AUR109 400mg — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Colorectal Cancer
Renal Cell Carcinoma
Biomarker criteria
Required: KRAS wild-type
IV EGFR antibodies (for KRAS wildtype)
Required: BRCA1 mutation
PARP inhibitors (for BRCA mutants)
Required: BRCA2 mutation
PARP inhibitors (for BRCA mutants)
Required: HER2 (ERBB2) amplification
anti-HER2 agents (e.g., FDA approved Tucatinib and Trastuzumab combination, where available) for HER2 amplified colorectal cancer
Required: FOLR1 amplification
mirvetuximab for folate receptor alpha amplified ovarian cancer
Required: UGT1A1 wild-type
Patients without any wild type allele (Such as *28/*28, *37/*37 or *37/*28 variants) genotypes for UGT1A1 [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: 5-FU based chemotherapy — Colorectal Carcinoma
5-FU based treatments
Must have received: oxaliplatin based chemotherapy — Colorectal Carcinoma
oxaliplatin based treatments
Must have received: irinotecan based chemotherapy — Colorectal Carcinoma
irinotecan-based treatments
Must have received: VEGF inhibitor — Colorectal Carcinoma
IV VEGF inhibitors
Must have received: EGFR antibody — Colorectal Carcinoma
IV EGFR antibodies (for KRAS wildtype)
Must have received: anti-PD-1 therapy — Colorectal Carcinoma
PD-1 antibodies for known MSI-H positive tumors
Must have received: regorafenib (regorafenib) — Colorectal Carcinoma
regorafenib
Must have received: lonsurf (lonsurf) — Colorectal Carcinoma
lonsurf
Must have received: anti-HER2 therapy (tucatinib, trastuzumab) — Colorectal Carcinoma
anti-HER2 agents (e.g., FDA approved Tucatinib and Trastuzumab combination, where available) for HER2 amplified colorectal cancer
Must have received: platinum-based chemotherapy — Ovarian Carcinoma
Tumor must be platinum refractory, defined as treatment free interval of < 6 months from the last platinum-based regimen
Must have received: topoisomerase inhibitor (topotecan) — Ovarian Carcinoma
topotecan
Must have received: antimetabolite (gemcitabine) — Ovarian Carcinoma
gemcitabine
Must have received: anthracycline (liposomal doxorubicin) — Ovarian Carcinoma
liposomal doxorubicin
Must have received: VEGF inhibitor (bevacizumab) — Ovarian Carcinoma
bevacizumab
Must have received: PARP inhibitor — Ovarian Carcinoma
PARP inhibitors (for BRCA mutants)
Must have received: antibody-drug conjugate (mirvetuximab) — Ovarian Carcinoma
mirvetuximab for folate receptor alpha amplified ovarian cancer
Must have received: VEGF inhibitor — Renal Cell Carcinoma
oral VEGF inhibitor
Must have received: anti-PD-1 therapy — Renal Cell Carcinoma
PD-1/PD-L1 inhibitors
Cannot have received: systemic anti-cancer therapy
Exception: within the past 28 days or 5 half-lives, whichever is longer, from the Cycle 1 Day 1 of the study
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
Cannot have received: radiation therapy
Exception: definitive radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed)
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)
Cannot have received: investigational agent
Exception: within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1
Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1
Lab requirements
Blood counts
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)
Kidney function
Creatinine clearance (CrCl) ≥ 30 mL/min (either measured or estimated by the Cockcroft-Gault formula)
Liver function
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)
Cardiac function
LVEF ≥ 50% at screening; QTcF ≤ 460 ms in both males and females
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) Albumin ≥ 3.0 g/dL LVEF < 50% at screening [excluded]. The QTcF (corrected QT interval Fridericia method) value in the screening ECG > 460 ms in both males and females [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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