Phase 1/2A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients with Advanced Solid Tumors

Inclusion Criteria:

1. Histologically or cytologically confirmed advanced (incurable, recurrent,unresectable, or metastatic) solid tumors.

2. For dose escalation cohort patients: patients must have a tumor type as definedin the protocol. Patients will have progression on or after or intolerance tomost recent systemic therapy. Patients must have received approved standardtherapy that is available to the patient that is known to confer clinicalbenefit, unless this therapy is contraindicated, intolerable to the patient, oris declined by the patient. The reason for treatment decline must be clearlydocumented in the medical record.

3. For backfill cohorts: patients must have a tumor type as defined in theprotocol. If patients decline an available standard therapeutic regimen knownto confer benefit to enroll on this study, the discussion must be clearlydocumented in the medical record.

4. Measurable disease per RECIST v1.1. Additionally, patients with breast or ovariancancer with non-measurable, evaluable disease are eligible.

5. ECOG performance status 0-1.

6. Life expectancy of at least 3 months.

7. Willing to provide a pretreatment tumor sample (either an archival sample or asample obtained by pretreatment biopsy).

8. All toxicity resulting from prior cancer therapies must have resolved to NCI CTCAEv5.0 ≤ Grade 1 or pre-therapy baseline with the exception of alopecia or ≤ Grade 2neuropathy.

9. Adequate hematological, renal, and hepatic function.

10. Other protocol-defined inclusion criteria apply.

Exclusion Criteria:

1. Receiving systemic corticosteroids at prednisone-equivalent dose of > 10 mg/daywithin 4 weeks prior to signing consent. Chronic systemic corticosteroid therapy forphysiologic replacement (≤ 10 mg/day of prednisone equivalents) and the use ofnon-systemic corticosteroids (e.g., inhaled, topical, intra-nasal, intra-articular,or ophthalmic) are permitted

2. History of Grade 4 allergic or anaphylactic reaction to prior monoclonal antibodytherapy or allergic reaction to any excipients within the investigational product

3. History of toxicity requiring permanent discontinuation of prior cancerimmunotherapy

4. Have an active autoimmune disease that has required systemic treatment in past 2years (replacement therapy is not considered a form of systemic treatment)

5. History of organ or stem cell transplant or need for immunosuppressive treatment

6. Have proteinuria > 2 + (within 7 days prior to initiation of study treatment).

7. Received any chemotherapy, immunotherapy or investigational anticancer therapywithin 3 weeks or 5 half-lives (whichever is shorter; minimum of 2 weeks) prior tofirst dose of study drug

8. Definitive radiotherapy within 6 weeks and palliative radiation within 2 weeks priorto the first dose of study drug. If previously irradiated, lesions must havedemonstrated clear-cut progression prior to being eligible for evaluation as targetlesions

9. Other protocol and subprotocol-defined exclusion criteria apply