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Clinical Trial 19776

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT03504488

Phase: Phase I/II
Principal Investigator:

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Study Title

A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 Alone and in Combination with Nivolumab in Patients with Advanced Solid Tumors



Phase 1 (Dose-Escalation Phase) Objectives Primary: To define the safety profile, including DLT, and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and other safety parameters of BA3021 administered every 21 days in patients with advanced solid tumors. Secondary: To assess the pharmacokinetics (PK) of BA3021 in patients with advanced solid tumors. To evaluate the immunogenicity of BA3021. Phase 2 (Dose-Expansion Phase) Objectives Primary: To assess antitumor activity of BA3021 in patients with specified tumor types. To assess the safety of BA3021. Secondary: To assess the PK of BA3021 in patients with advanced solid tumors. To evaluate the immunogenicity of BA3021. Exploratory: To explore the relationship between tumor ROR2 status and clinical response to BA3021 in patients with specified tumors. To evaluate potential candidate tumor and blood-based biomarkers for patient selection or correlation with antitumor activity of BA3021.



Therapy (NOS)


BA3021 ()

Inclusion Criteria

  • Patients must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed all available standard of care (SoC)therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy.
  • Patients with specified solid tumors must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Previously radiated tumor lesion should not be considered a target lesion.
  • Archived tissue or tissue from a tumor amenable to biopsy must be available and must be confirmed prior to receiving BA3021.
  • The following tumor types will be included in patients in Phase 1 cohort expansion and Phase 2; patients must have ROR2-positive disease as determined by BioAtla ROR2 assay based on archival tissue or biopsy (ROR expression cutoff: ≥ 1+ in ≥ 10% tumor cells): Stage IIIB/IV NSCLC: patients who previously received no more than 5 prior lines of SoC therapy.Triple-negative breast cancer: patients with diagnosis of triple-negative breast cancer (estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2)-negative carcinoma of the breast); no limit to the number of prior systemic therapies. Soft tissue sarcoma: patients with diagnosis of soft tissue sarcoma who had failed standard chemotherapy; no limit to the number of prior systemic therapies.
  • Patients must be age ≥ 18 years.
  • Patients must have an ECOG performance status of 0 or 1.
  • Patients must have a life expectancy of at least 3 months.
  • Tissue must be available to Sponsor for ROR2 and other gene expression testing. All patients must consent to provide a pretreatment tumor specimen within 12 months of the first dose of BA3021 for biomarker studies. See protocol for details.
  • Patients must have: - Completed (and recovered from treatment-related toxicities) any prior treatment with radiotherapy, chemotherapy, or targeted small molecule therapy and/or treatment with other investigational anticancer agents at least 5 half-lives or 2 weeks prior to first study dose, or biologics (such as a monoclonal antibody) at least 4 weeks prior to first study dose. Exceptions are bisphosphonates, denosumab and gonadotropin-releasing hormone agonist or antagonist. - Completed any prior treatment with nitrogen mustard agents, melphalan, or carmustine (BCNU) therapy at least 6 weeks prior to first study dose. - Received any prior autologous hematopoietic stem cell infusion at least 8 weeks prior to first study dose.
  • Patients must have adequate organ functions as indicated by laboratory values per protocol.
  • Patients must be available for periodic blood sampling, study-related assessments and management of toxicity at the treating institution and be willing to comply with the expected drug administration schedule.
  • Females of childbearing potential must have a negative serum or urine pregnancy test result prior to the first dose of BA3021 and must agree to use an effective contraceptive method, either a barrier/intrauterine method or a hormonal method, during the course of the study.
  • Both females and males, of childbearing/reproductive potential must agree to use adequate contraception while included in the study and for 6 months after the last infusion of BA3021.
  • Patients or their legally authorized representative must provide written informed consent.

  • Exclusion Criteria

  • Must not have clinically significant cardiac disease, in the judgment of the Investigator.
  • Must not have known congestive heart failure (New York Heart Association classes II-IV) or serious cardiac arrhythmia requiring treatment; patients with stable condition and medication for ≥ 3 months can be enrolled.
  • Must not have known non-controlled central nervous system metastasis.
  • Must not have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 3 weeks prior to first BA3021 administration.
  • Must not have a history of ≥ Grade 3 allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given during this study.
  • Must not have had major surgery within 4 weeks before first BA3021 administration.
  • Must not have any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke.
  • Must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
  • Must not have known additional malignancy that is active and/or progressive requiring treatment; patients with other malignancies that have been definitively treated and who have been rendered disease free will be eligible.
  • Must not have Grade 2 or higher peripheral neuropathy.
  • Must not have clinically significant (in the judgment of the Investigator) active viral, bacterial or fungal infection requiring systemic antibiotics/ antivirals/ antifungals.
  • Must not have known HIV, active hepatitis B, and/or hepatitis C.
  • Must not be pregnant or breastfeeding
  • Must not be using concurrent therapy with other anti-neoplastic or experimental agents.
  • Must not be using concurrent therapy with corticosteroids at greater than or equal to 12 mg/day prednisone equivalent.
  • Must not have any serious underlying medical condition that, in the opinion of the Investigator or Medical Monitor, would impair their ability to receive or tolerate the planned treatment. In such cases, the Sponsor-designated Medical Monitor must review each case prior to patient enrollment.

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