A Study to Assess the Safety and Preliminary Effectiveness of OBT076 in Recurrent and/or Metastatic CD205-positive Solid Tumors and in Women with CD205-positive HER2-negative Metastatic Breast Cancer


About this study

The purpose of this study is to determine the safety and tolerability of OBT076, and to define the maximum tolerated dose (MTD) and/or the RP2D of OBT076.

Participation eligibility

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

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.

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

Eligibility last updated 11/16/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mohamad Sonbol, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office


More information


Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions