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A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Positive Solid Tumors

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ClinicalTrials.gov Identifier: NCT04257110
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Bliss Biopharmaceutical (Hangzhou) Co., Ltd

Brief Summary:
This is an open-label, first-in-human (FIH), phase 1 dose-escalation and cohort expansion study of BB-1701 in subjects with locally advanced/metastatic HER2 positive solid tumors. The study consists of 2 parts: dose-escalation (Part 1) and cohort expansion (Part 2). Part 1 consists of dose escalation cohorts for determining the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Part 2 consists of expansion cohorts, including but not limited to breast cancer, gastric/gastroesophageal junction cancer, bladder cancer and colon cancer, for exploring 1 or more RP2Ds or schedules for expanding/deepening the information/knowledge about clinical safety, clinical pharmacokinetics and anti-tumor activity.

Condition or disease Intervention/treatment Phase
Locally Advanced/Metastatic HER2 Positive Solid Tumors Drug: BB-1701 Phase 1

Detailed Description:

This is an open-label, FIH, phase 1 dose-escalation and cohort expansion study of BB-1701 in subjects with locally advanced /metastatic HER2 positive solid tumors. The study consists of 2 parts: dose-escalation (Part 1) and cohort expansion (Part 2).

Part 1 of this study will follow accelerated titration and traditional "3 + 3" design. Part 2 is a cohort expansion study with HER2 positive locally advanced/metastatic solid tumors. Part 2 consists of 2 cohorts: Cohort 1 includes subjects with HER2 positive breast cancer, who must have received prior 3 lines of HER2 targeting therapies and Cohort 2 includes subjects with HER2 positive cancers including but not limited to gastric/gastroesophageal junction cancer (GC/GEJ), bladder cancer and colon cancer; prior HER2 therapy not required for cancer types other than GC/GEJ.

Study duration consists of Screening (up to 28 days), Treatment cycles (up to 8 cycles), and Safety Follow-up (30 days).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First-in-human, Open Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Positive Solid Tumors
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: Part 1: Dose-escalation
Eight doses levels have been selected for evaluation in the Part 1 of the study. Dose escalation decisions will be determined based on toxicities observed during the first cycle.
Drug: BB-1701
BB-1701 will be administered as an intravenous infusion, every 3 weeks.

Experimental: Part 2: Cohort 1
Subjects will be administered BB-1701 at one or two dose levels (e.g. MTD and the dose below MTD)
Drug: BB-1701
BB-1701 will be administered as an intravenous infusion, every 3 weeks.

Experimental: Part 2: Cohort 2
Subjects will be administered BB-1701 at one or two dose levels (e.g. MTD and the dose below MTD)
Drug: BB-1701
BB-1701 will be administered as an intravenous infusion, every 3 weeks.




Primary Outcome Measures :
  1. Number of subjects with adverse events and serious adverse events [ Time Frame: up to 2 years ]
    To evaluate the safety and tolerability of BB-1701

  2. Number of subjects with dose limiting toxicity (DLT) [ Time Frame: Cycle 1. Duration of each cycle is 21 days. ]
    Subjects are evaluated for all study drug related and treatment emergent toxicities based on the National Cancer Institute Common Toxicity Criteria for adverse events (NCI-CTCAE)

  3. MTD [ Time Frame: Cycle 1. Duration of each cycle is 21 days. ]
    MTD is defined as the highest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycle.


Secondary Outcome Measures :
  1. Area under the serum concentration time curve from time 0 extrapolated to infinity (AUC0-inf) [ Time Frame: Cycle 1 Day 1. Duration of each cycle is 21 days. ]
    To characterize the pharmacokinetics (PK) of BB-1701

  2. Maximum observed plasma concentration (Cmax) [ Time Frame: Pre-dose and post-dose during Cycle 1 through Cycle 8. Duration of each cycle is 21 days. ]
    To characterize the PK of BB-1701

  3. Incidence of anti-drug antibodies [ Time Frame: Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 4, 6, and 8. Duration of each cycle is 21 days. ]
    To assess the immunogenicity of BB-1701

  4. Objective response [ Time Frame: Every 9 weeks within 6 months and approximately every 12 weeks thereafter (up to 2 years) ]
    To assess the preliminary anti-tumor activity of BB-1701

  5. Progression Free Survival [ Time Frame: Every 9 weeks within 6 months and approximately every 12 weeks thereafter (up to 2 years) ]
    To assess the preliminary anti-tumor activity of BB-1701

  6. Duration of Response [ Time Frame: Every 9 weeks within 6 months and approximately every 12 weeks thereafter (up to 2 years) ]
    To assess the preliminary anti-tumor activity of BB-1701



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to provide written informed consent for the trial.
  2. Male or female subject ≥ 18 years.
  3. Subjects must have a histologically or cytologically confirmed locally advanced unresectable or metastatic HER2 positive solid tumor(s) for which no curative therapy is available or tolerable.
  4. Subjects must have at least one measurable lesion as defined per RECIST Version 1.1.
  5. Eastern Cooperative Oncology Group performance status of 0 or 1.
  6. Life expectancy ≥12 weeks.
  7. Serum bilirubin ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase ≤ 2.0 × ULN OR ≤ 3.0 × ULN for subjects with liver metastases.
  8. Subjects (women of childbearing potential and males with fertile female partner) must be willing to use currently accepted reliable contraception method throughout the treatment period and for at least seven months following the last dose of study drug.

Exclusion Criteria:

  1. Subjects receiving cancer therapy at the time of enrollment.
  2. Has not recovered from adverse events due to a previously administered agent.
  3. Had major surgery within 4 weeks before dosing.
  4. Use of any investigational anti-cancer drug within 28 days before the first investigational product administration.
  5. Subjects who have received prior cumulative doxorubicin dose > 360 mg/m² or equivalent
  6. Subjects with > Grade 2 peripheral neuropathy
  7. Has an active pneumonitis/interstitial lung disease (ILD), a history of pneumonitis/ILD that required systemic steroids, received radiotherapy to lung field within 12 months before the first dose of study intervention, or current clinically relevant lung disease
  8. Subjects with symptomatic or untreated central nervous system metastases, or those requiring ongoing treatment for central nervous system metastases, including steroids and antiepileptic agents.
  9. Any other serious underlying medical conditions, including but not limited to, uncontrolled diabetes mellitus, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders.
  10. Subjects with clinically significant cardiovascular disease, current dyspnea at rest due to complications of advanced malignancy.
  11. Active viral hepatitis (B or C)
  12. History of life-threatening hypersensitivity, or known to be allergic to protein drugs or recombinant proteins
  13. Any other serious underlying medical conditions, including but not limited to, psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect subject compliance or place the subject at high risk from treatment-related complications
  14. Females who are pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04257110


Contacts
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Contact: Wei Ziping, Ph D +86 18652443496 clinical@blissbiopharma.com

Locations
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United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94158
Contact: Pamela Munster    415-353-9535    Pamela.Munster@ucsf.edu   
China
Cancer Hospital Chinese Academy of Medical Science Not yet recruiting
Beijing, China, 100021
Contact: Fei Ma    86-13910217780    13910217780@139.com   
Sponsors and Collaborators
Bliss Biopharmaceutical (Hangzhou) Co., Ltd

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Responsible Party: Bliss Biopharmaceutical (Hangzhou) Co., Ltd
ClinicalTrials.gov Identifier: NCT04257110    
Other Study ID Numbers: BB-1701-101
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bliss Biopharmaceutical (Hangzhou) Co., Ltd:
Maximum tolerated dose
Recommended Phase 2 dose
First-in-human
Additional relevant MeSH terms:
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Neoplasms