Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors

Open to people ages 18 years and up

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.

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.