Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patient -
1. Is able to understand and voluntarily sign a written informed consent and is
willing and able to comply with the protocol requirements including scheduled
visits, treatment plan, laboratory tests and other study procedures.
2. Is aged ≥ 18 years
3. Has pathologically confirmed advanced or metastatic malignancy characterized by
one or more of the following:
1. Patient is intolerant of existing therapy(ies) known to provide clinical
benefit for their condition
2. Malignancy is refractory to existing therapy(ies) known to potentially
provide clinical benefit
3. Malignancy has relapsed after standard therapy
4. Malignancy for which there is no standard therapy that improves survival by
at least 3 months
4. Has evaluable tumor(s) by standard radiological and/or laboratory assessments as
applicable to their malignancy - in Part 3, patients with solid tumors must have
least 1 measurable lesion per response evaluation criteria in solid tumors
(RECIST) v1.1 criteria, measured preferably by computed tomography (CT) scan or
magnetic resonance image (MRI). In the case of patients with glioblastoma
multiforme (GBM) or other central nervous system (CNS) tumors, the tumor must be
measurable, defined as a clearly enhancing tumor with at two perpendicular
diameters at entry equal or superior to 1cm.
5. Has laboratory function within specified parameters (may be repeated):
1. Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 500/mL;
hemoglobin ≥ 8.5 g/dL, platelets ≥ 50,000/mL
2. Adequate liver function: transaminases (aspartate aminotransferase/ alanine
aminotransferase, AST/ALT) and alkaline phosphatase ≤ 3 (≤ 5 X the upper
limit of normal (ULN) in the setting of liver metastasis or infiltration
with malignant cells) x ULN; bilirubin ≤ 1.5 x ULN
3. Adequate renal function: creatinine clearance ≥ 60 mL/min (Cockcroft and
Gault)
4. Adequate blood coagulation: international normalized ratio (INR) ≤ 2.3
5. Serum amylase and lipase ≤ 1.5 x ULN
6. Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG)
PS 0-2
7. Has received the final dose of any of the following treatments/ procedures with
the specified minimum intervals before first dose of study drug (unless in the
opinion of the investigator and the study medical coordinator the treatments/
procedures will not compromise patient safety or interfere with study conduct and
with IDMC agreement):
- Chemotherapy, immunotherapy, or systemic radiation therapy - 14 days or ≥ 5
half-lives (whichever is shorter)
- Focal radiation therapy - 7 days
- Systemic and topical corticosteroids - 7 days
- Surgery with general anesthesia - 7 days
- Surgery with local anesthesia - 3 days
8. May continue endocrine therapies (e.g. for breast or prostate cancer) and/or
anti-human epidermal growth factor (Her2) therapies while on this study
9. Women of childbearing potential must have a negative baseline blood or urine
pregnancy test within 72 hours of first study therapy. Women may be neither
breastfeeding nor intending to become pregnant during study participation and
must agree to use effective contraceptive methods (hormonal or barrier method of
birth control, or true abstinence) for the duration of study participation and in
the following 90 days after discontinuation of study treatment
10. Male patients with partners of childbearing potential must take appropriate
precautions to avoid fathering a child from screening until 90 days after
discontinuation of study treatment and use appropriate barrier contraception or
true abstinence
11. Must not be receiving any other investigational medicinal product
Exclusion Criteria:
- Patient -
1. Is pregnant or lactating
2. Is known to be hypersensitive to any of the components of 9-ING-41 or to the
excipients used in its formulation
3. Has not recovered from clinically significant toxicities as a result of prior
anticancer therapy, except alopecia and infertility. Recovery is defined as ≤
Grade 2 CTCAE Version 4.03
4. Has significant cardiovascular impairment: history of congestive heart failure
greater than New York Heart Association (NYHA) Class II, unstable angina, or
stroke within 6 months of the first dose of 9-ING-41, or cardiac arrhythmia
requiring medical treatment detected at screening
5. Has had a myocardial infarction within 12 weeks of the first dose of 9-ING-41 or
has electrocardiogram (ECG) abnormalities that are deemed medically relevant by
the investigator or study medical coordinator
6. Has known symptomatic rapidly progressive brain metastases or leptomeningeal
involvement as assessed by CT scan or MRI. Patients with stable asymptomatic
brain metastases or leptomeningeal disease or slowly progressive disease are
eligible provided that they have not required new treatments for this disease in
a 28-day period before the first dose of study drug, and anticonvulsants and
steroids are at a stable dose for a period of 14 days prior to the first dose of
study drug
7. Has had major surgery (not including placement of central lines) within 7 days
prior to study entry or is planned to have major surgery during the course of the
study (major surgery may be defined as any invasive operative procedure in which
an extensive resection is performed, e.g. a body cavity is entered, organs are
removed, or normal anatomy is altered. In general, if a mesenchymal barrier is
opened (pleural cavity, peritoneum, meninges), the surgery is considered major)
8. Has any medical and/or social condition which, in the opinion of the investigator
or study medical coordinator would preclude study participation
9. Has received an investigational anti-cancer drug in the 14-day period before the
first dose of study drug (or within 5 half-lives if longer) or is currently
participating in another interventional clinical trial
10. Has a current active malignancy other than the target cancer
11. Is considered to be a member of a vulnerable population (for example, prisoners)
Part 3 ARMB Inclusion Criteria: Patient -
1. Is able to understand and voluntarily sign a written informed consent and is willing
and able to comply with the protocol requirements including scheduled visits,
treatment plan, laboratory tests and other study procedures
2. Is aged ≥ 18 years
3. Has pathologically confirmed metastatic pancreatic cancer AND is previously untreated
with systemic agents in the recurrence/metastatic setting.
4. Must have at least 1 measurable lesion per RECIST v1.1, measured preferably by
computed tomography (CT) scan or magnetic resonance image (MRI)
5. Has laboratory function within specified parameters (may be repeated):
e. Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 500/mL; hemoglobin
≥ 8.5 g/dL, platelets ≥ 75,000/mL f. Adequate liver function: transaminases (aspartate
aminotransferase/ alanine aminotransferase, AST/ALT) and alkaline phosphatase ≤ 3 (≤
10 X the upper limit of normal (ULN) in the setting of liver metastasis or
infiltration with malignant cells) x ULN; bilirubin ≤ 1.5 x ULN Adequate renal
function: creatinine clearance ≥ 30 mL/min (Cockcroft and Gault)
6. Has Eastern Co-operative Oncology Group (ECOG) PS 0 or 1
7. Has received the final dose of any of the following treatments/ procedures with the
specified minimum intervals before first dose of study drug:
- Focal radiation therapy - 7 days
- Surgery with general anesthesia - 7 days
- Surgery with local anesthesia - 3 days
8. May have received treatment with fluorouracil or gemcitabine as a radiation sensitizer
in the adjuvant setting if the treatment was received at least 6 months before study
enrollment
9. May have received neoadjuvant chemotherapy with FOLFIRINOX if last dose given at least
6 months before study enrollment
10. May have received prior cytotoxic doses of systemic chemotherapy in the adjuvant
setting if last dose given at least 6 months before study enrollment
11. Women of childbearing potential must have a negative baseline blood or urine pregnancy
test within 72 hours of first study therapy. Women may be neither breastfeeding nor
intending to become pregnant during study participation and must agree to use
effective contraceptive methods (hormonal or barrier method of birth control, or true
abstinence) for the duration of study participation and in the following 90 days after
discontinuation of study treatment
12. Male patients with partners of childbearing potential must take appropriate
precautions to avoid fathering a child from screening until 90 days after
discontinuation of study treatment and use appropriate barrier contraception or true
abstinence
13. Must not be receiving any other investigational medicinal product
Patient who meets ANY of the following criteria is not eligible for this Part 3 study Arm
B:
Exclusion Criteria:
1. Is pregnant or lactating
2. Is known to be hypersensitive to any of the components of 9-ING-41 or to the
excipients used in its formulation
3. Has endocrine or acinar pancreatic carcinoma
4. Has not recovered from clinically significant toxicities as a result of prior
anticancer therapy, except alopecia and/or infertility. Recovery is defined as ≤ Grade
2 severity per CTCAE, v5.0
5. Has significant cardiovascular impairment: history of congestive heart failure greater
than New York Heart Association (NYHA) Class II, unstable angina, or stroke within 6
months of the first dose of study therapy, or uncontrolled cardiac arrhythmia
6. Has had a myocardial infarction within 12 weeks of the first dose of study therapy or
has electrocardiogram (ECG) abnormalities that are deemed medically relevant by the
investigator
7. Has symptomatic rapidly progressive brain metastases or leptomeningeal involvement as
assessed by CT scan or MRI. Patients with stable brain metastases or leptomeningeal
disease or slowly progressive disease are eligible provided that they have not
required new treatments for this disease in a 28-day period before the first dose of
study drug, and anticonvulsants and steroids are at a stable dose for a period of 14
days prior to the first dose of study drug
8. Has had major surgery (not including placement of central lines) within 7 days prior
to study entry or is planned to have major surgery during the course of the study
(major surgery may be defined as any invasive operative procedure in which an
extensive resection is performed, e.g., a body cavity is entered, organs are removed,
or normal anatomy is altered. In general, if a mesenchymal barrier is opened (pleural
cavity, peritoneum, meninges), the surgery is considered major)
9. Has any medical and/or social condition which, in the opinion of the investigator or
study medical coordinator would preclude study participation.
10. Has received an investigational anti-cancer drug in the 14-day period before the first
dose of study drug (or within 5 half-lives if longer) or is currently participating in
another interventional clinical trial.
11. Has a current active malignancy other than pancreatic cancer
12. Is considered to be a member of a vulnerable population (for example, prisoners).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 5/30/23. Questions regarding updates should be directed to the study team contact.