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BRIEF TITLE: BDC-1001 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced HER2-Expressing Solid Tumors

Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced HER2-Expressing Solid Tumors


  • Org Study ID: BBI-20201001
  • Secondary ID:
  • NCT ID: NCT04278144
  • NCT Alias:
  • Sponsor: Bolt Biotherapeutics, Inc. - Industry
  • Source: Bolt Biotherapeutics, Inc.

Brief Summary

A first-in-human study using BDC-1001 in HER2 expressing advanced malignancies

Detailed Description


This study has four parts. Part 1 is a dose escalation of BDC-1001 as a single agent to
determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), or maximum
protocol dose (MPD) recommended for Part 3. In Part 3, the selected dose will be administered
as monotherapy to patients with selected advanced malignancies. Part 2 is a dose escalation
of BDC-1001 in combination with pembrolizumab to determine the maximum tolerated dose (MTD),
recommended Phase 2 dose (RP2D), or maximum protocol dose (MPD) recommended for Part 4. In
Part 4, the selected dose will be administered in combination with pembrolizumab to patients
with selected advanced malignancies.

Overal Status Start Date Phase Study Type
Recruiting February 24, 2020 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Incidence of adverse events (AEs) and serious adverse events (SAEs)

Primary Outcome 1 - Time Frame: 2 years

Primary Outcome 2 - Measure: Incidence and nature of dose-limiting toxicities (DLTs)

Primary Outcome 2 - Time Frame: up to 21 days

Primary Outcome 3 - Measure: Incidence of potential-immune related toxicities

Primary Outcome 3 - Time Frame: 2 years

Primary Outcome 4 - Measure: Maximum tolerable dose (MTD) or a tolerated dose below MTD

Primary Outcome 4 - Time Frame: 2 years

Primary Outcome 5 - Measure: Overall response rate (ORR) of confirmed complete or partial responses (CR, PR)

Primary Outcome 5 - Time Frame: 2 years

Condition:

  • HER2 Positive Solid Tumors

Eligibility

Criteria:
Key Inclusion Criteria:

- Patient must have an advanced solid tumor with documented HER2-protein expression or
gene amplification for which approved therapies have been exhausted or are not
clinically indicated.

- Measurable disease as determined by RECIST v.1.1.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Tumor tissue (archival or collected prior to the study start) available for
exploratory biomarker evaluation.

Key Exclusion Criteria:

- History of severe hypersensitivity to any ingredient of the study drug(s), including
trastuzumab or other monoclonal antibody.

- Previous treatment with a TLR 7, TLR 8 or a TLR 7/8 agonist.

- Impaired cardiac function or history of clinically significant cardiac disease

- Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or
hepatitis C infection.

- Active SARS-CoV-2 infection

- Untreated central nervous system (CNS), epidural tumor or metastasis, or brain
metastasis.

Other protocol defined inclusion/exclusion criteria may apply.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Amreen Husain, MD

Role: Study Director

Affiliation: Bolt Biotherapeutics

Overall Contact

Name: Bolt Biotherapeutics

Phone: 1-650-665-9295

Email: info@boltbio.com

Locations

Facility Status Contact
Stanford University
Palo Alto, California 94304
United States
Recruiting Wyatt Gross
650-721-4076
gross@stanford.edu
Georgetown University Medical Center
Washington, District of Columbia 20007
United States
Recruiting Stephanie Wagner, RN
202-687-9782
sw1095@georgetown.edu
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Recruiting DFCI Clinical Trials Hotline
877-338-7425
Henry Ford Hospital
Detroit, Michigan 48202
United States
Recruiting Karie Gignac, RN
313-695-9808
Kgignac1@hfhs.org
START Midwest
Grand Rapids, Michigan 49546
United States
Recruiting Kathy Estkowski

kathy.estkowski@startmidwest.com
Columbia University Medical Center
New York, New York 10032
United States
Recruiting
212-342-5162
cancerclinicaltrials@cumc.columbia.edu
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United States
Recruiting Bob Li, MD
646-888-4201
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Recruiting Phase I Referrals

phaseI-referrals@ouhsc.edu
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting Ecaterina I Dumbrava, MD
713-563-1930
EEIleana@mdanderson.org
South Texas Accelerated Research Therapeutics
San Antonio, Texas 78229
United States
Recruiting Isabel Jimenez, RN
210-593-5265
isabel.jimenez@startsa.com
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Recruiting Alexander Spira, MD, PhD, FACP
703-280-5390
Samsung Medical Center
Seoul, Gangnam-gu 06351
Korea, Republic of
Recruiting Jeeyun Lee, MD
+82-2-3410-1754
jyunlee@skku.edu
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
Korea, Republic of
Recruiting Keun-Wook Lee, MD, PhD
+82-31-787-7037
imdoctor@snu.ac.kr
Asan Medical Center
Seoul, Songpa-gu 05505
Korea, Republic of
Recruiting Yoon-Koo Kang, MD, PhD
+82-2-3010-3230
ykkang@amc.seoul.kr