Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This study evaluates the anti-tumor effects of ORIN 1001 in patients with advanced solid
tumors or relapsed refractory metastatic breast cancer (patients with progressive disease
after receiving at least two lines of therapy in the advanced setting).
Phase
Phase 1/Phase 2
Funding Agency/Sponsor
Industrial
Disease
Breast Cancer
Enrollment Eligibility
Inclusion Criteria:
For dose escalation with ORIN1001 alone:
-Male or female with advanced solid tumors for which no effective standard of care
treatments are available
For dose escalation with ORIN1001 in combination with Abraxane:
-Males or females with relapsed refractory metastatic breast cancer (TNBC or ER+, HER2-)
must have progressed through at least 2 lines of therapy and for whom there are no
available therapies that confer a clinical benefit
For dose expansion:
a. Males or females with relapsed refractory metastatic breast cancer including:
1. TNBC (i.e. estrogen receptor (ER)-, progesterone receptor-, and human epidermal growth
factor receptor 2 [HER2]-)
2. ER+ HER2- breast cancer
Inclusion Criteria for Dose Escalation and Dose Expansion
1. Adults aged ≥ 18 years
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
3. Life expectancy of 3-4 months
4. Have at least one measurable lesion per RECIST 1.1
5. Have adequate organ function, including all of the following:
1. Adequate bone marrow reserve as defined by: ANC≥1.0 x 10 9/L; platelet count ≥75
x 10 9/L; hemoglobin ≥9 g/dL
2. Hepatic: total bilirubin ≤2 x ULN, transaminases (AST/SGOT and/or ALT/SGPT) ≤ 3X
ULN;alkaline phosphatase ≤ 5 x ULN
3. Renal: 24-hour creatinine clearance ≥ 30 mL/min calculated
6. Adequate tissue sample from either archival tumor tissue or fresh biopsy of tumor at
the screening for tumor genotyping.
7. Male subjects must be surgically sterile or must agree to use physician approved
contraception for 7 days prior to the first study drug administration to 30 days after
the last dose of study treatment.
8. Women of childbearing potential must have negative serum pregnancy test within 14 days
prior the first administration of study drug and agree to use physician-approved
contraception from 30 days prior to the first study drug administration to 30 days
following the last study drug administration.
9. Ability to understand and willingness to sign an informed consent prior to any study
specific procedures.
10. Resolution of all toxicities (except alopecia) from prior therapy to ≤ Grade 1 (CTCAE
v5)
Exclusion Criteria:
1. Does not meet inclusion criteria
2. Received any of the following within the specified time frame prior to the first
administration of study drug:
i. Excluding those with a history of coagulopathy ii. Excluding those who require
concurrent use of anti-coagulants or anti-platelet medication, with exception of
aspirin doses ≤ 81 mg/day, prophylaxis subcutaneous (SC) heparin or SC low-molecular
weight heparin for deep vein thrombosis (DVT) prophylaxis or heparin flushes to
maintain IV catherer patency iii. Excluding subjects that have Prothrombin time
(PT)/international normalized ratio (INR) or activated partial thromboplastin time
(aPTT) >1.5 x ULN b.Prior chemotherapy or other systemic anticancer therapy within 3
weeks or 5 times the plasma half-life of the drug, whichever is shorter; c.Prior
radiotherapy within 2 weeks; d.Major surgery within 2 weeks; e.Prior treatment with
investigational drugs within 4 weeks; f. Myocardial infarction, uncontrolled
angina,severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence
of acute ischemia, within 6 months prior to the fist dose of study drug
3. Greater than Class II heart failure using New York Heart Association (NYHA) criteria
4. The subject has uncontrolled human immunodeficiency virus (HIV) infection or active
hepatitis B or C infection or other known active and/or uncontrolled infection
5. Active autoimmune disease that is not appropriately controlled with treatment
6. Active malignancy with the exception of:
1. adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ
cervical cancer
2. adequately treated stage I cancer from which the subject is currently in
remission, or
3. any other cancer from which the subject has been disease-free for ≥3 years;
7. Any serious uncontrolled medical or psychological disorder that would impair the
ability to receive protocol therapy
8. Any condition which places the subject at unacceptable risk or confounds the ability
of the investigator to interpret study data
9. The subject is pregnant or lactating woman. Any woman who becomes pregnant during the
study will be withdrawn from the study.
10. Known active uncontrolled or symptomatic brain metastases. Patients with a history of
such metastases that have been treated and are stable ≥28 days may be enrolled.
Patients with no steroid use for at least 2 weeks prior to the time of enrollment are
permitted.
11. Failed to respond to the most recent dose of Abraxane and must have been received at
least 12 months prior to starting treatment.(combination arm only)
12. Greater than Grade 1 neuropathy (combination arm only)