BDB001-102: Open Label Dose Escalation of BDB001 in Combination w Atezolizumab

NCT04196530 | Completed Phase 1 FDA Drug

• 1 other identifier: BDB001-102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

A Phase 1 Open-label Dose Escalation Study of BDB001 in Combination with Atezolizumab in Subjects with Advanced Solid Tumors

Conditions

Tumor, Solid

Keywords

TLR7/8; Immuno-oncology; EIK1001

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability: incidence of adverse events and any dose limiting toxicity

  Safety and tolerability of BDB001 in combination with atezolizumab as measured by the incidence of adverse events and any dose limiting toxicities (DLT)

  up to 21 months

• Determine Maximum Tolerated Dose (MTD) or recommended Phase 2 Dose (RP2D)

  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

  from first dose to 21 days after first dose for each patient

Secondary Outcomes (1)

• Radiographic Determination of Tumor Response after BDB001 in combination with atezolizumab dosing

  At the beginning of Cycle 3 (every cycle is 21 days) up to 30 months after the first dose for each patient

Study Arms (2)

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.

Drug: BDB001 (EIK1001); Drug: Atezolizumab

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.

Drug: BDB001 (EIK1001); Drug: Atezolizumab

Interventions

BDB001 (EIK1001) DRUG

BDB001 (EIK1001) is an immunotherapy agent.

Dose Escalation of BDB001 with atezolizumab; Dose Expansion of BDB001 with atezolizumab

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.

Also known as: Tecentriq

Dose Escalation of BDB001 with atezolizumab; Dose Expansion of BDB001 with atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Be 18 years of age on day of signing informed consent
• Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors who have disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment. Note: there is no limit to the number of prior treatment regimens
• A male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP)
• A WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment
• A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year, when used consistently and correctly)
• Evidence of progressive disease (PD) within 3 months of signing the informed consent form
• Have measurable disease with at least 1 lesion meeting measurable criteria per irRECIST as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
• Eastern Cooperative Oncology Group (ECOG) score of 0 - 2
• Minimum life expectancy of 3 months
• Have adequate organ function. Specimens must be collected within 10 days prior to the start of study treatment.
• Hematological: ANC ≥1500/µL; Platelets ≥100 000/µL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
• Renal: serum creatinine ≤ 1.5 times the ULN or estimated creatinine clearance ≥ 60 mL/min (Cockcroft and Gault formula \[http://www.mdcalc.com/creatinine-clearance-cockcroft-gault-equation/\])

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• A Woman of Child Bearing Potential who has a positive urine pregnancy test (e.g. within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Prior exposure to TLR 7 agonists, such as GS-9620, imiquimod, TMX 101, resiquimod, MEDI9197, and 825A, or TLR 9 agonists such as SD-101, tilsotolimod (IMO-2125), MGN1703, GNKG168, DUK-CPG-001 and CMP-001 for treatment of the solid tumor the subject is currently being evaluated for treatment with BDB001.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor such as CTLA-4, OX40, and CD137, and was discontinued from that treatment due to a Grade 3 or higher irAE.
• Received previous therapy for malignancy within 21 days prior to administration of study drug, including any investigational agents (other than BDB001), chemotherapy, immunotherapy, biological or hormonal therapy. Subjects receiving systemic interferons or IL-2 must have discontinued the drug 4 weeks or 5 half-lives (whichever is longer) prior to initiation of study treatment because these drugs could potentially increase the risk of autoimmune conditions when given in combination with atezolizumab. Subjects receiving nitrosoureas or mitomycin C must have discontinued the drug 6 weeks prior to initiation of study treatment.
• Subjects who are receiving a RANKL inhibitor such as denosumab prior to enrollment must be willing and eligible to receive a bisphosphonate instead; denosumab could potentially alter the activity and the safety of atezolizumab.
• Major surgery within 4 weeks of first dose of study drug
• Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
• Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed
• Currently receiving medications known to be strong inhibitors of CYP1A and CYP3A and strong/moderate inducers of CYP1A and CYP3A
• Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 21 days prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 21 days after the last dose of the previous investigational agent
• History within last 6 months of New York Heart Association Class III or IV heart failure, acute myocardial infarction, angina pectoris, uncontrolled arrhythmia, acute coronary syndromes, stent placement, uncontrolled hypertension
• QTc interval value \> 470 msec (using Fridericia's Correction)
• Left ventricular ejection fraction (LVEF) \< 50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan

Sponsors & Collaborators

• Eikon Therapeutics: lead
• Seven and Eight: collaborator

Study Sites (5)

Angeles Clinic

Los Angeles, California, 90025, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 34230, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

BDB001; atezolizumab

Study Officials

• Harry Raftopoulos, MD

  Eikon Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: November 21, 2019
• Primary Completion: July 31, 2024
• Study Completion: August 15, 2024
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)