Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04819373 | BDB001-201: A Clinical Study of BDB001 in Patients With PD-(L)1 Refractory Solid Tumors | PHASE2 | COMPLETED | 1 | — | — | Aug 30, 2021 | May 1, 2023 | Nov 12, 2025 | 1 | United States |
| NCT04196530 | BDB001-102: Open Label Dose Escalation of BDB001 in Combination w Atezolizumab | PHASE1 | COMPLETED | 40 | — | — | Nov 21, 2019 | Aug 15, 2024 | Nov 12, 2025 | 5 | United States |
| NCT03486301 | BDB001-101: Clinical Study of BDB001 as a Mono-therapy or in Combination With Pembrolizumab | PHASE1 | COMPLETED | 87 | — | — | Feb 15, 2018 | Apr 30, 2024 | Nov 12, 2025 | 5 | United States |
Objective Response Rate
Safety and tolerability of BDB001 in combination with atezolizumab as measured by the incidence of adverse events and any dose limiting toxicities (DLT)
Determination of the MTD or RP2D by assessing the frequency and severity of adverse events related to BDB001 when given in combination with atezolizumab using CTCAE version 5.0 to categorize adverse event severity
| Arm | Type | Description |
|---|---|---|
| BDB001 | EXPERIMENTAL | BDB001 will be administered intravenously as monotherapy in subjects with histologically-confirmed unresectable or metastatic solid tumors that have progressed on anti-PD-1 or anti-PD-L1 mAb treatment either as monotherapy or in combination with other therapies. |
| Dose Escalation of BDB001 with atezolizumab | EXPERIMENTAL | This part of the study will follow a traditional 3+3 dose escalation design. Each successive group of patients will be enrolled at an incrementally higher dosage until the Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D) of BDB001 with atezolizumab is reached. |
| Dose Expansion of BDB001 with atezolizumab | EXPERIMENTAL | At the end of the dose escalation part of the study, the BDB001 dose to be used in combination with atezolizumab in the expansion part of the study will be established after thorough review of all available safety, preliminary efficacy, PK and PD data. A biologically active dose will be selected that is either the MTD, if one was established in the escalation part, or an RP2D if no MTD was established. Approximately 20 additional subjects will initially be enrolled in the dose expansion part. |
| Single Agent BDB001 (EIK1001) | EXPERIMENTAL | A single subject will be enrolled at each dose level in the single agent arm until any ≥ Grade 2 treatment-emergent adverse event (TEAE) is observed in the first cycle. Then dosage escalation will follow a traditional 3+3 dose escalation design. Each successive group of patients will be enrolled at an incrementally higher dosage until the Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D) of single agent BDB001 is reached. |
| BDB001 in Combination with Pembrolizumab | EXPERIMENTAL | In the combination arm of the study, a standard 3+3 dose escalation design will be utilized for all dose levels. When the MTD or RP2D of single agent BDB001 is reached, the first dose level cohort of the combination arm will begin. Once the MTD or RP2D in combination has been determined, twenty additional subjects will be enrolled in the expansion phase of the study. |
| Name | Type | Description |
|---|---|---|
| BDB001 | DRUG | BDB001 is an immunotherapy agent. |
| BDB001 (EIK1001) | DRUG | BDB001 (EIK1001) is an immunotherapy agent. |
| Atezolizumab | DRUG | Atezolizumab is a is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1). Atezolizumab has an acceptable preclinical safety profile and is approved as an IV therapy for a variety of advanced malignancies. |
| Pembrolizumab | DRUG | Pembrolizumab is a potent humanized monoclonal antibody with high specificity of binding to the PD 1 receptor. Pembrolizumab has an acceptable preclinical safety profile and is approved as an IV therapy for a variety of advanced malignancies. |
Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply: 1. Histologically or cytologically confirmed: Cutaneous SCC, Head and Neck SCC, Melanoma, Merkel Cell Carcinoma, NSCLC, Renal Cell Carcinoma, or Urothelial Carcinoma. Other tumor t...