Clinical Trials

Inclusion Criteria:

• ECOG Performance Status (PS) 0, 1, or 2
• Life expectancy of ≥3 months
• Measurable or assessable disease:
  • For histiocytic neoplasms and lymphoma-measurable disease is defined as measurable by CT (dedicated CT or the CT portion of a PET/CT) or MRI: To be considered measurable, there must be at least one lesion that has a single diameter of ≥1.5 cm for non-CNS disease. For CNS involved disease, MRI confirmation with any size would be appropriate. NOTE: Skin lesions can be used if the area is ≥1.5 cm in at least one diameter and photographed with a ruler. Patients with assessable disease by PET/CT are also eligible as long as the assessable disease is biopsy proven lymphoma or histiocytic/dendritic cell neoplasms.
• The following laboratory values obtained ≤14 days prior to registration:
  • Hemoglobin ≥8.0 g/dL
  • Absolute neutrophil count (ANC) ≥1.0 x 109/L
  • Platelet count ≥80 x 109/L
  • WBC ≥2.5 x 109/L
  • Total bilirubin ≤1.5 x ULN
  • Alanine aminotransferase (ALT), aspartate transaminase (AST), and alkaline phosphatase (ALP) ≤2.5 x ULN (≤5 x ULN for patients with liver involvement)
  • Serum Creatinine of ≤1.5 x ULN and calculated creatinine clearance of ≥50 mL/min 
• Negative urine or serum pregnancy test done ≤7 days prior to registration, for persons of childbearing potential only.
• Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate prior to study entry and for the duration of study participation and for at least 3 months after the last dose of study drug. Note: The following are considered effective contraceptives: oral contraceptive pill; condom plus spermicide; diaphragm plus spermicide; patient or partner surgically sterile; patient or partner more than 2 years postmenopausal; or injectable or implantable agent/device.
• Provide written informed consent.
• Ability to complete questionnaire(s) by themselves or with assistance.
• Willing to return to the enrolling institution for follow-up (during the Active Monitoring Phase of the study).

Exclusion Criteria:

• Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effect on the developing fetus and newborn are unknown:
  • Pregnant persons
  • Nursing persons
  • Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception. 
• New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure ≤6 months prior to registration. 
• Corrected QT interval (using Fridericia’s correction formula) (QTcF) of >470 msec.
• Known active infection with human immunodeficiency virus (HIV), HTLV-1, hepatitis B virus (HBV), or hepatitis C virus (HCV): 
  • Active infection with (HIV) and CD4+ T-cell count <350 μL.
  • Patients with a detectable HIV viral load and not on antiretroviral therapy (ART) for ≥4 weeks.
  • Exceptions: 
    • Patients with a history of hepatitis B or C are allowed if HBV DNA or HCV RNA are undetectable.
    • Patients with active HIV infection and CD4+ T-cell count ≥350 μL who are on active antiretroviral treatment.
•  Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. 
• Concomitant use of strong inhibitors and inducers of CYP1A2, CYP2C19, CYP2D6, and strong inhibitors and inducers of CYP3A4 within five half-lives of the active drug prior to registration and throughout the trial (See Appendix II for a list). Note: Strong inhibitors and inducers of CYP3A4 should be discontinued for five half-lives of the active drug prior to starting study drug and avoided throughout the trial. 
• Concomitant use of any herbal supplements. Note: Supplements taken prior to starting study drug should be discussed with the Principal Investigator as varied washout periods may be clinically indicated and necessary. 
• Any of the following prior therapies used as primary cancer treatment:  
  • Targeted therapeutics other than monoclonal antibodies (e.g., kinases inhibitors) ≤2 weeks prior to registration.
  • Monoclonal antibodies ≤6 weeks, or ≥5 half-life, whichever is shorter, prior to registration.
  • Chemotherapy ≤4 weeks prior to registration (6 weeks for nitrosoureas or Mitomycin C.
  • Surgery ≤4 weeks prior to registration
  • Any investigational therapy ≤4 weeks prior to registration.
  • Radiation therapy ≤4 weeks prior to registration 
  • • Exceptions: 
      • Palliative radiation therapy ≥2 weeks prior to registration for control of tumor mass related symptoms (e.g., pain control from a discrete bone metastasis) allowed, unless the radiation field includes organs for which the radiation therapy could result in certain direct organ toxicities (e.g., radiation induced esophagitis), which could complicate the interpretation of the Q702 safety profile.
      • Radiation induced toxicities which could interfere with the interpretation of the Q702 safety profile should recover to ≤grade 1 before registration 
      • Patients receiving palliative radiation intended to reduce the risk of a potential pathological fracture should be allowed ≥4 weeks from the last radiation therapy treatment to recover from any radiation induced toxicity and to allow for an adequate period of observation relative to the potential risk of a pathological fracture.
• Failure to recover from acute, reversible effects of prior therapy to ≤Grade 1 or patient baseline prior to registration. NOTE: Patient with chronic effects such as neuropathy, fatigue, keratitis/keratopathy, anorexia, etc. are allowed.
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
• Active retinal pigment epithelium (RPE)/photoreceptor disorders such as retinitis pigmentosa, cone-rod dystrophies, Bests dystrophy, Stargardt disease (STGD), macular degeneration, retinal detachment, and opaque cornea. Exceptions:
  • Mild blurry vision, either age-related or due to ocular or systemic disorder (e.g., diabetes, dry eyes, cataracts, uncorrected refraction abnormality) may be allowed at the discretion of the ophthalmologist if deemed as not constituting evidence of pre-existing retinopathy (e.g., severe non-proliferative or proliferative diabetes retinopathy) or a condition with the potential to cause a predisposition to drug-induced retinopathy. [e.g., severe retinal vascular disease with scattered intraretinal hemorrhages, cotton wool-spots and intraretinal microvascular abnormalities (IRMA)]
  • Patients with only one assessable eye and no evidence of pre-existing retinopathy may be allowed at the discretion of the principal investigator.
• Active second malignancy requiring treatment that would interfere with the assessment of the response of the primary cancer or interpretation of the safety of this protocol therapy.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 07/02/2024. Questions regarding updates should be directed to the study team contact.