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Brief Title: A First-in-human Study Using BDC-1001 in 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

INTRODUCTION

  • Org Study ID: BBI-20201001
  • Secondary ID: N/A
  • NTC ID: NCT04278144
  • Sponsor: 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.


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

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: 2 years

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

Primary Outcome 2 - Timeframe: up to 21 days

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

Primary Outcome 3 - Timeframe: 2 years

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

Primary Outcome 4 - Timeframe: 2 years

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

Primary Outcome 5 - Timeframe: 2 years

CONDITION

  • HER2 Positive Solid Tumors

ELIGIBILITY


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.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Amreen Husain, MD

Role: Study Director

Affiliation: Bolt Biotherapeutics

Overall Contact

Name: Amreen Husain, MD

Phone: 1-650-665-9295

Email: info@boltbio.com

LOCATION

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

kathy.estkowski@startmidwest.com
Facility: Columbia University Medical Center
New York, New York 10032
United States 		Status: Recruiting Contact:

212-342-5162
cancerclinicaltrials@cumc.columbia.edu
Facility: Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United States 		Status: Recruiting Contact:
Bob Li, MD
646-888-4201
Facility: Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States 		Status: Recruiting Contact:
Phase I Referrals

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

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