First-in-human Study of DB-1305 for Advanced/Metastatic Solid Tumors

December 18, 2023 updated by: DualityBio Inc.

A Phase 1/2a, Multicenter, Open-Label, Non-Randomized First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1305 in Subjects With Advanced/Metastatic Solid Tumors

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1305 in subjects with advanced solid tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, non-randomized, open-label, multiple-dose, first in human (FIH) study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D); Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic malignant solid tumors.

Study Type

Interventional

Enrollment (Estimated)

345

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • Site 219
        • Contact:
          • Haiyan Tu
    • Anhui
      • Bengbu, Anhui, China, 233099
        • Recruiting
        • Site 211
        • Contact:
          • Dianming Li, MD
      • Hefei, Anhui, China, 230031
        • Recruiting
        • Site 217
        • Contact:
          • Zhihong Zhang, PhD
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Not yet recruiting
        • Site 213
        • Contact:
          • Xiangqi Chen, PhD
    • Guangxi
      • Nanning, Guangxi, China, 531200
        • Recruiting
        • Site 209
        • Contact:
          • Weimin Xie, PhD
    • Guanxi
      • Guigang, Guanxi, China, 537100
        • Recruiting
        • Site 221
        • Contact:
          • Yan Wei
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Site 202
        • Contact:
          • Min Yan, PhD
    • Hubei
      • Wuhan, Hubei, China, 430021
        • Not yet recruiting
        • Site 205
        • Contact:
          • Xiaorong Dong, MD
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341006
        • Recruiting
        • Site 208
        • Contact:
          • Hua Yang, MD
    • Jilin
      • Changchun, Jilin, China, 130012
        • Recruiting
        • Site 201
        • Contact:
          • Ying Cheng, MD
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Recruiting
        • Site 210
        • Contact:
          • Tao Sun, Doctor
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Site 216
        • Contact:
          • Yuping Sun, PhD
      • Linyi, Shandong, China, 276304
        • Recruiting
        • Site 212
        • Contact:
          • Jianhua Shi, MD
    • Shanghai
      • Shanghai, Shanghai, China, 201315
        • Recruiting
        • Site 207
        • Contact:
          • Jian Zhang, Doctor
    • Sichuan
      • Chengdu, Sichuan, China, 611135
        • Not yet recruiting
        • Site 206
        • Contact:
          • Lu Li, MD
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Site 203
        • Contact:
          • Chen Wang, MD
    • Zhejiang
      • Taizhou, Zhejiang, China, 317004
        • Recruiting
        • Site 220
        • Contact:
          • Dongqing Lv, MD
  • Puerto Rico
      • Mayaguez, Puerto Rico, 00682
        • Recruiting
        • BRCR GLOBAL Puerto Rico LLC.
        • Contact:
          • Maryangely Moreno Campa, MD
  • United States
    • California
      • Cerritos, California, United States, 90703
        • Recruiting
        • Site 103
        • Contact:
          • Omkar Marathe, MD
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Site 108
        • Contact:
          • Aaron E. Lisberg, MD
    • Florida
      • Margate, Florida, United States, 33063
        • Recruiting
        • D&H Cancer Research Center LLC
        • Contact:
          • David Kahn, MD
      • Plantation, Florida, United States, 33322
        • Recruiting
        • Site 109
        • Contact:
          • Harshad Amin, MD
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • BRCR Medical Center Inc.
        • Contact:
          • Chintan Gandhi, MD
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Site 106
        • Contact:
          • Hirva Mamdani, MD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Site 102
        • Contact:
          • Maria Michelle Rubinstein, MD
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Site 101
        • Contact:
          • Nashat Y. Gabrail, MD
        • Principal Investigator:
          • Nashat Y. Gabrail, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Site 105
        • Contact:
          • Erika Paige Hamilton, MD
    • Texas
      • Arlington, Texas, United States, 76017
        • Recruiting
        • Site 110
        • Contact:
          • Gerald Edelman, MD, PhD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Site 104
        • Contact:
          • Senthil Damodaran, MD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Site 107
        • Contact:
          • Alexander Spira, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
  • Histologically or cytologically confirmed unresectable advanced/ metastatic solid tumors who have relapsed or progressed on or after standard systemic treatments or for which no standard treatment is available.
  • At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
  • Has a life expectancy of ≥ 3 months.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
  • Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
  • Has adequate organ functions within 7 days prior to Day 1 of Cycle 1.
  • Has adequate treatment washout period prior to Day 1 of Cycle 1.
  • Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of Trop-2 level and other biomarkers if no contraindication.
  • Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.

Exclusion Criteria:

  • Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
  • Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
  • Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to > 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.
  • Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
  • Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.
  • Subjects have human immunodeficiency virus (HIV) infection with acquired immune deficiency syndrome (AIDS) defining illness are not eligible for enrollment; However, subjects have had HIV infection with a cluster of differentiation 4 (CD4)+ T cell count > 350 cells/µL and no history of an AIDS-defining illness are eligible for entry.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DB-1305 Dose Level 1
Enrolled subjects will receive a single-dose of DB-1305 at Dose Level 1 on Day 1 of each cycle Q3W
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Experimental: DB-1305 Dose Level 2
Enrolled subjects will receive a single-dose of DB-1305 at Dose Level 2 on Day 1 of each cycle Q3W
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Experimental: DB-1305 Dose Level 3
Enrolled subjects will receive a single-dose of DB-1305 at Dose Level 3 on Day 1 of each cycle Q3W
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Experimental: DB-1305 Dose Level 4
Enrolled subjects will receive a single-dose of DB-1305 at Dose Level 4 on Day 1 of each cycle Q3W
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Experimental: DB-1305 Dose Level 5
Enrolled subjects will receive a single-dose of DB-1305 at Dose Level 5 on Day 1 of each cycle Q3W
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Experimental: DB-1305 Dose Expansion 4
Enrolled subjects with BC who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Experimental: DB-1305 Dose Expansion 5
Enrolled subjects with TNBC who have progressed on or after standard systemic treatments and without prior treatment of sacituzumab govitecan who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Experimental: DB-1305 Dose Expansion 6
Enrolled subjects with TNBC with treatment failure on sacituzumab govitecan who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Experimental: DB-1305 Dose Expansion 1
Enrolled subjects with NSCLC with AGAs who will receive a single-dose of DB-1305 on a selected dose level once every 3 weeks
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Experimental: DB-1305 Dose Expansion 2
Enrolled subjects with NSCLC without AGAs who will receive a single-dose of DB-1305 on a selected dose level once every 3 weeks
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Experimental: DB-1305 Dose Expansion 3
Enrolled subjects with OC who will receive a single-dose of DB-1305 on a selected dose level once every 3 weeks
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Experimental: DB-1305 Dose Expansion 7
Enrolled subjects with EC with disease progression on or after treatment with at least one platinum-containing regimen for advanced or metastatic disease with or without immune checkpoint inhibitor (ICI) who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Experimental: DB-1305 Dose Expansion 8
Enrolled subjects with malignant mesothelioma who have progressed on or after standard systemic treatments who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Experimental: DB-1305 Dose Expansion 9
Enrolled subjects with CC who have progressed on or after standard systemic treatments who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Experimental: DB-1305 Dose Expansion 10
Enrolled subjects with other advanced or metastatic solid tumors who have progressed on or after standard systemic treatments who will receive a single-dose of DB-1305 on a selected dose level (RP2D) once every 3 weeks
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Experimental: DB-1305 Dose Expansion 11
Enrolled subjects with NSCLC without AGAs who has not received PD-1/PD-L1, PD-L2, CTLA-4 directed immunotherapy and previously received ≤1 line of platinum-based chemotherapy for advanced or metastatic NSCLC who will receive a single-dose of DB-1305 on a selected dose level in combination with pembrolizumab 200mg once every 3 weeks
Drug: DB-1305
Administered I.V.
Other Names:
  • DB-1305 for Injection
Combination product: Pembrolizumab
Administered I.V.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
Time Frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0
Up to follow-up period, approximately 1 year post-treatment
Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Time Frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0
Up to follow-up period, approximately 1 year post-treatment
Phase 2a: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.
Time Frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0
Up to follow-up period, approximately 1 year post-treatment
Phase 2a: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Time Frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0
Up to follow-up period, approximately 1 year post-treatment
Phase 2a: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.
Time Frame: Up to follow-up period, approximately 1 year post-treatment
The percentage of subjects who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks
Up to follow-up period, approximately 1 year post-treatment
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.
Time Frame: up to 21 days after Cycle 1 Day 1
Percentage of participants in Part 1 with DLTs
up to 21 days after Cycle 1 Day 1
Maximum Tolerated Dose (MTD) of DB-1305
Time Frame: 12 months
MTD on the data collected during Part 1
12 months
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1305
Time Frame: 12 months
RP2D of DB-1305 based on the data collected during Part 1
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 & Phase 2a: Pharmacokinetic-AUC
Time Frame: within 8 cycles (each cycle is 21 days)
Area under the concentration-time curve from time 0 to infinity of DB-1305
within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-Cmax
Time Frame: within 8 cycles (each cycle is 21 days)
Maximum observed plasma concentration (Cmax) of DB-1305
within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-Tmax
Time Frame: within 8 cycles (each cycle is 21 days)
Time to Cmax of DB-1305
within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-T1/2
Time Frame: within 8 cycles (each cycle is 21 days)
Terminal elimination half-life
within 8 cycles (each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DualityBio Inc.

Investigators

  • Study Director: Raymond Zhao, MD, DualityBio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2022

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

June 24, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DB-1305-O-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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