Single-agent dose escalation in Chinese patients with advanced solid tumors. Nine dose groups: 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 650 mg, 900 mg, 1200 mg, and 1500 mg orally in 21-day cycles.

A total of 27-54 evaluable patients are expected to be enrolled. However, the dose in the escalation phase is not limited to these dose groups, and the number of enrolled patients is not limited to 27-54.

ORIN1001 will be administered daily as a tablet in combination with standard of care. This arm of the study will be carried out in 8 different cancer indications, including advanced triple-negative breast cancer received ≥ 3 lines of treatment, postmenopausal ER+/HER2-advanced breast cancer received the 1 line of treatment, advanced hepatocellular carcinoma received 1/2 line of treatment, chemotherapy-naive castrate-resistant prostatic cancer, advanced pancreatic cancer received 1/2 line of treatment, platinum-resistant/refractory advanced ovarian cancer received ≥ 2 lines of treatment, non-small cell lung cancer received ≥ 2 lines of treatment, and esophageal cancer received ≥ 2 lines of treatment.

After the recommended phase 2 dose of single-agent ORIN1001 is determined, a single-agent efficacy expansion study for advanced esophageal cancer, as well as a single-agent efficacy expansion study for advanced solid tumors with failure of standard treatments or no effective standard treatment.

After the recommended phase 2 dose of the combination treatment is determined, the efficacy expansion study of the combination treatment will be conducted in the corresponding 8 different indications.

Dose escalation of ORIN1001 as a single agent or in combination with standard of care. Dose expansion of ORIN1001 as a single agent or in combination with standard of care.

ORIN1001

Lin Shen, MD

Dose escalation of ORIN1001 in patients with advanced solid tumors.

Dose escalation of ORIN1001 in combination with standard of care in patients with esophageal carcinoma, metastatic breast cancer, hepatocellular carcinoma, metastatic prostate cancer, pancreatic cancer, ovarian cancer and non-small cell lung cancer.

Dose expansion of ORIN1001 as a single agent or in combination with standard of care in patients with advanced solid tumors.

Dose escalation of ORIN1001 administered as a single agent in patients with advance solid tumors. ORIN1001 is administered daily as a tablet.

Dose escalation of ORIN1001 administered in combination with standard of care in patients with esophageal carcinoma, triple negative breast cancer, ER+/HER2- metastatic breast cancer, hepatocellular carcinoma, metastatic castration-sensitive prostate cancer, pancreastic cancer, ovarian cancer and non-small cell lung cancer.

Dose expansion of single agent or combination therapy with ORIN1001 in patients with advanced solid tumors.

Treatment of Patients With Advanced Solid Tumors With Oral Agent ORIN1001 and in Combination With Standard of Care.

A Multicenter, Open-label, Phase I Clinical Study: A Dose-finding and Dose Expansion Study to Evaluate ORIN1001 Monotherapy and Its Combination in Patients With Advanced Solid Malignant Tumors

Whole blood sample collected for Hematology evaluation

whole blood sample collected for Serum clinical chemistry

Electrocardiogram (ECG) - A 12-lead ECG will evaluate electrical cardiac intervals P, QRS, and QT.

Ultrasound Cardiogram (MUGA) will evaluate a cardiac physiologic parameter.

ECOG performance score (Eastern Cooperative Oncology Group) will be measured by clinician. ECOG scores range from 0 to 5. 0 is fully active and 5 is death.

Body weight in kilogram (kg) will be measured on a calibrated scale.

A blood sample will be collected to determine the concentration of ORIN1001 in plasma using analysis in a clinical lab.

Blood pressure, including systolic and diastolic measurements.

CT Scan to evaluation tumor growth and size over time.

Biopsy sample - tumor genotype evaluation

From the biopsy of the tumor sample, immunohistochemistry evaluation will be performed to evaluate expression levels of XBP1 in tumor tissue (Pharmacodynamic-PD biomarker)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Treatment of Patients With Advanced Solid Tumors With Oral Agent ORIN1001 and in Combination With Standard of Care.	NCT05154201	Effect of Drug	ORIN1001	18 Years -	Orinove, Inc.
Treatment of Patients With Advanced Solid Tumors With Oral Agent ORIN1001 and in Combination With Standard of Care.	NCT05154201	Effect of Drug	ORIN1001	18 Years -	Orinove, Inc.

Spots Global Cancer Trial Database for orin1001

Every month we try and update this database with for orin1001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for orin1001

Every month we try and update this database with for orin1001 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for orin1001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.