Treatment of Patients With Advanced Solid Tumors With Oral Agent ORIN1001 and in Combination With… (NCT05154201) | Clinical Trial Compass
CompletedPhase 1/2
Treatment of Patients With Advanced Solid Tumors With Oral Agent ORIN1001 and in Combination With Standard of Care.
China150 participantsStarted 2020-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, ≥ 18 years of age.
. Single-agent dose-finding period and single-agent expansion cohort of advanced solid tumors: Patients with advanced solid tumors confirmed by histology or cytology who previously failed standard treatment (including surgery, chemotherapy, radiotherapy or biological therapy) or have no effective standard treatment; dose escalation and expansion period of combination therapy: Histologically or cytologically confirmed advanced breast cancer, hepatocellular carcinoma, prostatic cancer, pancreatic cancer, ovarian cancer, non-small cell lung cancer and esophageal cancer (see the inclusion criteria of each indication for details).
. Provide evidence of disease progression or intolerable toxicity as confirmed by the investigator or documented in the medical history before enrollment;
. Adequate organ functions, including all the following functions: Adequate bone marrow reserve, defined as: Absolute neutrophil count (ANC) ≥ 1.0 × 109/L; lymphocytes count ≥ 0.5 × 109/L; platelet count ≥ 100 × 109/L; hemoglobin ≥ 90 g/L; liver function (except hepatocellular carcinoma cohort): Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN), ≤ 3.0 × ULN for patients with Gilbert syndrome; aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; ALP ≤ 2.5 × ULN; AST, ALT, ALP ≤ 5 × ULN for liver cancer patients or patients concomitantly with liver metastases; INR and APTT \< 1.5 × ULN (patients receiving anticoagulant therapy are required to maintain dose stability within the recent two weeks (liver cancer patients are not allowed to take anticoagulants simultaneously for patients); renal function: Creatinine \< 1.5 × ULN, or normal range of serum creatinine or creatinine clearance ≥ 50ml/min/1.73m2. Creatinine clearance is calculated using the Cockroft-Gault formula. Albumin ≥ 30 g/L.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of tolerability
Timeframe: Change from baseline through completion of study
2
Assessment of tolerability
Timeframe: Change from baseline through completion of study
3
Assessment of tolerability
Timeframe: Change from baseline through completion of study
4
Assessment of tolerability
Timeframe: Change from baseline through completion of study
5
Assessment of tolerability
Timeframe: Change from baseline through completion of study
6
Assessment of tolerability
Timeframe: Evaluated during baseline or pre-intervention and during intervention.
7
Assessment of tolerability
Timeframe: Change from baseline through completion of study
. Known left ventricular ejection fraction (LVEF) \> 50%.
. Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
. Patients with at least one evaluable lesion (single-agent dose escalation period) and at least one measurable lesion (single-agent dose expansion and combination therapy dose-finding/expansion period) according to RECIST Version 1.1.
. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
Exclusion criteria
. Patients do not meet inclusion criteria.
. Having received monoclonal antibody, chemotherapy, radiotherapy, or other investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) before the start of dosing. Having received surgery or not recovered from surgery within 2 weeks before starting dose.
. Central nervous system metastasis or injury without a stable control (patients with stable disease for more than 3 months who have received intracranial radiotherapy，there is no need hormone therapy are allowed).
. Spinal cord compression was not treated with surgery and/or radical radiotherapy (previously diagnosed spinal cord compression clinically symptom or stable for ≥ 3 months after treatment is allowed.
. Patients who have not recovered from toxic reactions caused by previous anti-tumor treatment (≥ NCI-CITCAE 5.0 grade 2, except alopecia); patients with uncontrolled diabetes (patients who are receiving stable insulin regimen or hypoglycemic agent regimen and are evaluated by specialists to have a stable blood glucose control are allowed).
. Patients with a history of coagulation disorders; patients requiring anticoagulant or antiplatelet therapy (aspirin dose ≤ 81 mg/d, orally and subcutaneous injection of low-molecular-weight heparin preventing of deep venous thrombosis is allowed).
. The subjects have a history of malignancy other than the indication for inclusion within the past three years, with the exception of radically treated non-melanoma basal cell carcinoma of the skin or carcinoma in situ of the cervix.
Pharmacokinetic Evaluation
Timeframe: Collected on Day 1 and on Day 21 or Day 28. One cycle with single agent is 21 days and one cycle in combination with chemotherapy is 28 days.
9
Assessment of tolerability
Timeframe: Change from baseline through completion of study
10
Assessment of tolerability
Timeframe: Change from baseline through completion of study
11
Assessment of tolerability
Timeframe: Change from baseline through completion of study
12
Assessment of tolerability
Timeframe: Change from baseline through completion of study