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Clinical Trial 19776

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

Phase: Phase I/II
Principal Investigator: Saltos, Andreas

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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.



Immunotherapy; Therapy (NOS)


BA3021 (); BMS-936558 (Nivolumab); Nivolumab (Opdivo)

Inclusion Criteria

Inclusion Criteria:

  • Phase 1: Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors and have failed all available SoC therapy and for whom no curative therapy is available or who are not eligible, intolerant to, or refuse standard therapy. Phase 2: Patients must: a. Have histologically or cytologically confirmed locally advanced unresectable or metastatic NSCLC or melanoma. b. Have prior disease progression on or after receiving a PD-1/L-1 (NSCLC and melanoma patients), epidermal growth factor receptor (EGFR) inhibitor (NSCLC), or anaplastic lymphoma kinase (ALK) inhibitor (NSCLC).
  • Documented progression according to RECIST Version 1.1 criteria within the 6 months prior to enrollment.
  • At least one measurable lesion according to RECIST v1.1. Previously radiated tumor lesion should not be considered a target lesion.
  • 18 years of age or older
  • ECOG performance status of 0 or 1.
  • Life expectancy of at least 3 months.
  • In Phase 1 dose expansion and Phase 2, must have ROR2-positive disease determined by BioAtla ROR2 immunohistochemistry (IHC) assay based on archival tissue or biopsy; a minimum of 3 core samples are required to ensure a sufficient quantity of cells are obtained. For Phase 1 dose expansion, the ROR2 expression is >/= 1+ in >/= 10% tumor cells. For Phase 2 Part 1, a a TmPS >/=1% (consisting of 1+, 2+, and 3+ intensities) is considered positive. For Phase 2 Part 2, the ROR2 TmPS cut-off will be determined based on data from Phase 1 and Phase 2 Part 1.
  • Tissue amenable to biopsy or archived tumor tissue must be available to the Sponsor for ROR2 and other gene expression testing. Fresh biopsy is preferred*. All patients must consent to provide a pre-treatment tumor specimen for biomarker studies. For older archival samples (e.g., obtained more than 12 months before Screening), Sponsor approval of the sample must be obtained. If archival tissue is unavailable, patients must consent to undergo a tumor biopsy during Screening. Core needle (a minimum of 3 core samples are required) or excisional biopsies or resected tissue specimens are required. *Note: Tumor tissue samples taken after having disease progression on a PD-1/L1, EGFR, or ALK inhibitor are much more likely to express higher levels of target antigen that may enable a candidate to participate in the study.
  • Must have: (a) 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 [mAb]) at least 4 weeks prior to first study dose. Exceptions are bisphosphonates, denosumab and gonadotropin-releasing hormone agonist or antagonist. (b) Completed any prior treatment with nitrogen mustard agents, melphalan, or carmustine (BCNU) therapy at least 6 weeks prior to first study (c) Received any prior autologous hematopoietic stem cell infusion at least 8 weeks prior to first study dose.
  • Adequate organ function as defined in protocol.
  • 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.
  • Prior to the first dose of BA3021, females of childbearing potential must have a negative serum or urine pregnancy test result, and throughout the study and for 6 months after the last dose of BA3021 must agree to use an effective contraceptive method. Male patients of reproductive potential must agree to use effective contraception while included in the study and for 6 months after the last infusion of BA3021.
  • Additional criteria may apply

  • Exclusion Criteria

  • Clinically significant cardiac disease, in the judgment of the Investigator.
  • 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.
  • Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment.
  • Severe renal impairment
  • Known non-controlled central nervous system (CNS) metastasis.
  • Phase 1 only: Received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 3 weeks prior to first BA3021 administration.
  • A history of grade 3 or greater allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given during this study.
  • Major surgery within 4 weeks before first BA3021 administration.
  • Known intracerebral arteriovenous malformation, cerebral aneurysm, or stroke. Patients treated and with stable condition for 3 months or more can be enrolled.
  • Prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
  • 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.
  • Ongoing peripheral sensory or motor neuropathy > Grade 1 or recent (6 months) onset of Grade 1 neuropathy and/or prior history of any > Grade 2 neuropathy of any etiology and/or any hereditary neuropathy, including, but not limited to Charcot-Marie-Tooth disease.
  • Clinically significant (in the judgment of the Investigator) active viral, bacterial or fungal infection requiring systemic antibiotics/ antivirals/ antifungals.
  • Known history of positive testing for human immunodeficiency virus (HIV) infectiion or known acquired immunodeficiency (AIDS).
  • Known active hepatitis B (e.g., HBsAg reactive) or active hepatitis C (e.g., HCV RNA (qualitative) is detected.
  • Women who are pregnant or breastfeeding
  • Using concurrent therapy with other anti-neoplastic or experimental agents.
  • Phase 1 only: 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.
  • Additional criteria apply

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