Clinical Study of BDB018: Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Phase 1 Open-Label Dose Escalation Study of BDB001 as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors


Główny sponsor: Seven and Eight Biopharmaceuticals Inc

Źródło Birdie Biopharmaceuticals HK Limited
Krótkie podsumowanie

A Phase 1 Open-label Dose Escalation Trial of BDB018 in Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

szczegółowy opis

This clinical trial is a study of an experimental drug called BDB018. BDB018 is a next-generation Toll-like receptor (TLR) 7/8 agonist that activates the immune system. The primary objectives of this study are to evaluate the safety and tolerability of BDB018 in monotherapy and in combination with pembrolizumab (Keytruda) in subjects with unresectable or metastatic solid tumors that have relapsed or are refractory to standard treatment or for which there is no approved therapy. This is a multi-center, open-label, dose escalation/dose expansion Phase 1 study of BDB018 in monotherapy and in combination with pembrolizumab. The study will be conducted in two separate but independent parts: a dose escalation part with BDB018 in monotherapy and in combination with pembrolizumab and a dose expansion part of BDB018 in combination with pembrolizumab.

Ogólny stan Not yet recruiting
Data rozpoczęcia 2021-04-30
Data zakończenia 2023-12-01
Podstawowa data ukończenia 2023-03-01
Faza Phase 1
Typ studiów Interventional
Wynik podstawowy
Pomiar Ramy czasowe
Safety and Tolerability: incidence of adverse events and any dose limiting toxicity Up to 30 months
Wynik drugorzędny
Pomiar Ramy czasowe
Determine Maximum Tolerated Dose From first dose to 21 days after first dose for each patient (cycle 1)
Radiographic Determination of Tumor Response after BDB018 Dosing Every 63 days (3 cycles) up to 30 months after the first dose for each patient (each cycle is 21 days)
Rekrutacja 50
Stan: schorzenie

Rodzaj interwencji: Drug

Nazwa interwencji: BDB018

Opis: BDB018 is an immunotherapy agent.

Rodzaj interwencji: Drug

Nazwa interwencji: Pembrolizumab

Opis: 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.

Etykieta grupy ramion: BDB018 in Combination with Pembrolizumab



Inclusion Criteria 1. Histologically or cytologically confirmed advanced or metastatic solid tumors that 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 2. Evidence of progressive disease (PD) within 3 months of signing the informed consent form. 3. Have measurable disease Exclusion Criteria: 1. Has disease that is suitable for local therapy administered with curative intent. 2. Prior exposure to TLR7 agonists, TLR8 agonists, TLR 7/8 dual agonists, and TLR9 agonists. Other protocol defined inclusion/exclusion criteria could apply



Minimalny wiek:

18 Years

Maksymalny wiek:


Zdrowi wolontariusze:


Ogólnie urzędnik
Nazwisko Rola Przynależność
Robert Andtbacka, MD, CM, Study Chair Seven and Eight Biopharmaceuticals Inc
Ogólny kontakt

Nazwisko: Robert Andtbacka, MD,CM,

Telefon: 18483000086

E-mail: [email protected]

Obiekt: Kontakt:
Honor Health | Scottsdale, Arizona, 85266, United States Seven and Eight Biopharmaceuticals
Florida Cancer Specialists | Sarasota, Florida, 34230, United States 7 & 8 Biopharma 848-300-0086 Manish Patel, MD Principal Investigator
Kraje lokalizacji

United States

Data weryfikacji


Odpowiedzialna impreza

Rodzaj: Sponsor

Słowa kluczowe
Liczba ramion 2
Grupa Arm

Etykieta: BDB018 in Monotherapy

Rodzaj: Experimental

Opis: A single subject will be enrolled at each dose level in the single agent arm. 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 BDB018 is reached.

Etykieta: BDB018 in Combination with Pembrolizumab

Rodzaj: Experimental

Opis: 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 BDB018 is reached, the first dose level cohort of the combination arm will begin. Once the MTD or RP2D in combination has been determined, approximately twenty additional subjects will be enrolled in the expansion phase of the study.

Dane pacjenta Undecided
Badanie informacji o projekcie

Przydział: Non-Randomized

Model interwencji: Sequential Assignment

Podstawowy cel: Treatment

Maskowanie: None (Open Label)

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