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:
1. Subject is ≥ 18 years of age (at the time of signing the ICF) with non-curative recurrent and/or metastatic solid tumors for which a standard therapy is not available or is no longer effective.
2. Subject has histologically and/or cytologically confirmed solid tumors.
3. Subject has recurrent and/or metastatic cancer (based on most recently analyzed biopsy) defined by ASCO-CAP guidelines as negative in situ hybridization test or an
IHC status of 0, 1+, or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
4. Prior treatment with checkpoint inhibitors is allowed.
5. Subject has tumor that is positive for CD205 antigen by IHC staining
6. Subject has an ECOG performance status of 0-1.
7. Subject has radiological documented measurable disease (i.e., at least 1 measurable lesion as per RECIST Version 1.1).
8. Subject has adequate organ function
9. Subject has adequate bone marrow function
10. Subject understands and voluntarily signs an ICD prior to any study-related assessments/procedures are conducted.
11. Subject is able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
1. Subject has received any chemotherapy within 21 days prior to inclusion in the study.
2. Subject has received another investigational therapy within 28 days.
3. Subject has not recovered from the acute toxic effects (CTCAE grade ≤ 1) of prior anticancer therapy, radiation, or major surgery/significant trauma (except alopecia or
other toxicities not considered a safety risk for the subject at the Investigator's discretion).
4. Subject has had major surgery within 14 days prior to starting study treatment or has not recovered from major side effects.
5. Subject has had radiotherapy ≤ 4 weeks prior to starting study drug.
6. Subject has a history of, or current symptomatic brain metastasis.
7. Subject has severe renal impairment (creatinine clearance < 30 mL/min).
8. Subject has any other malignancy within 5 years prior to randomization
9. Subject has a known or suspected hypersensitivity or other contraindication to any excipients used in the manufacture of OBT076.
10. Subject has significant active cardiac disease within the previous 6 months including unstable angina or angina requiring surgical or medical intervention, significant
cardiac arrhythmia, or NYHA class 3 or 4 congestive heart failure.
11. Subject has a known history or current diagnosis of HIV infection, unless on triple antiviral treatment with undetectable viral load.
12. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would, in the Investigator's judgment, contraindicate subject
participation in the study (e.g., history of thromboembolic event, cardiac dysfunction, chronic pancreatitis, chronic active hepatitis).
13. Subject has any condition that confounds the ability to interpret data from the study.
14. Subject is a female of childbearing potential.
15. Subject is lactating or breastfeeding.
16. Patient has a past medical history of or ongoing clinically relevant interstitial lung disease, drug-induced pneumonitis or severe/very severe COPD.
17. Patient has active or chronic corneal disorder or Sjogren’s syndrome.
18. Patient has any ongoing skin disorders not controlled by specific treatment.
19. Patient has significant active cardiac disease within the previous 6 months including unstable angina or angina requiring surgical or medical intervention, significant cardiac arrhythmia, or NYHA class 3 or 4 congestive heart failure, or patients with QTc interval >470ms at screening.
20. Patient has a known history or current diagnosis of HIV infection, unless on triple antiviral treatment with undetectable viral load.
21. Patient is a female of childbearing potential [defined as a sexually mature woman who 1) has not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time during the preceding 12 consecutive months)] and is not using any adequate form of birth control.
22. Patient is unable or unwilling to take folic acid or vitamin B12 supplementation.
23. History of allogeneic organ transplant.
24. Patients with grade 3 or 4 immune-related adverse reactions during any prior line of checkpoint inhibitor containing therapy. Patients with immune-related thyroiditis controlled with substitution, or prior asymptomatic lipase increases are eligible for the study.
25. Active autoimmune disease or history of autoimmune disease that required systemic treatment within 3 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 1/11/24. Questions regarding updates should be directed to the study team contact.