Overview
Study OBT076-001 is an open-label, Phase I, dose escalation and expansion clinical study of OBT076 in CD205+ve recurrent and/or metastatic solid tumors that are refractory to standard treatments, or for which a standard therapy is not available or not suitable or is no longer effective. The study will consist of four parts:
* Part A: Dose escalation
* Part B: OBT076 single agent expansion
* Part C: Sequential administration of OBT076 and balstilimab
* Part D: Combination therapy with concurrent administration of OBT076 and balstilimab
Parts A, B, C and D will consist mainly of 3 periods: Screening, Treatment and Follow-up periods. The treatment period with OBT076 consists of 21 days cycles. Approximately 200 patients will be enrolled across Parts A to D.
Principal investigator
Eligibility criteria
Exclusion Criteria: 1. Subject has received any chemotherapy within 28 days prior to Cycle 1 Day 1. 2. Subject has received any other systemic anticancer therapy within 28 days or 5 half-lives of Cycle 1 Day 1. 3. Subject has symptomatic visceral crisis requiring chemotherapy per Investigator judgment for non TNBC. 4. Subject with colorectal cancer and pancreatic cancer are not eligible for the study. 5. Subject with peritoneal involvement, i.e., peritoneal carcinomatosis, are not eligible for the study. 6. 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). 7. Subject has had major surgery within 14 days prior to starting study treatment or has not recovered from major side effects. 8. Subject has had radiotherapy ≤ 4 weeks prior to starting study drug. 9. Subject has a history of, or current symptomatic brain metastasis. 10. Subject has any other malignancy within 5 years prior to randomization 11. Subject has a known or suspected hypersensitivity or other contraindication to any excipients used in the manufacture of OBT076. 12. Subject has significant medical condition, laboratory abnormality, or psychiatric illness that would, in the Investigator's judgment, contraindicate patient participation in the study (e.g., history of thromboembolic event, cardiac dysfunction, chronic pancreatitis, chronic active hepatitis) 13. Subject has severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine \<7 days before Cycle 1 Day 1 14. Subject has any condition that confounds the ability to interpret data from the study. 15. Subject is lactating or breastfeeding. 16. Subject has a past medical history of or ongoing clinically relevant interstitial lung disease, drug-induced pneumonitis or severe/very severe COPD. 17. Subject has active or chronic corneal disorder or Sjogren's syndrome. 18. Subject has any ongoing skin disorders not controlled by specific treatment. 19. 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, or patients with QTc interval \>470ms at screening. 20. Subject has a known history or current diagnosis of HIV infection, unless on triple antiviral treatment with undetectable viral load. 21. Subject who is female of childbearing potential 22. Subject who is unable or unwilling to take folic acid or vitamin B12 supplementation. 23. Subject with a history of allogeneic organ transplant. 24. Subject 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. Subject with active autoimmune disease or history of autoimmune disease that required systemic treatment within 3 years of the start of study treatment.
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