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NCT06953089 | NOT YET RECRUITING | Solid Tumors

DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Sponsor:

DualityBio Inc.

Brief Summary:

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

Condition or disease

Solid Tumors

Intervention/treatment

DB-1311/BNT324

BNT327

DB-1305/BNT325

Phase

PHASE2

Detailed Description:

This is a phase II, multicenter, open-label, two-part trial designed to evaluate the safety and preliminary efficacy of DB-1311 in combination with BNT327 or DB-1311 in combination with DB-1305 in targeted participants. Participants with recurrent, progressive as well as advanced, metastatic hepatocellular carcinoma (HCC), cervical cancer (CC), melanoma, head and neck squamous cell carcinoma (HNSCC) or non-small cell lung cancer (NSCLC) are eligible to participate in the trial.

Study Type : INTERVENTIONAL
Estimated Enrollment : 440 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors
Actual Study Start Date : 2025-06-30
Estimated Primary Completion Date : 2030-06-30
Estimated Study Completion Date : 2030-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Adults aged ≥ 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent.
  • * At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria.
  • * Has a life expectancy of ≥ 3 months.
  • * Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
  • * Has adequate organ function within 7 days prior to enrollment/randomization,
  • * Has adequate treatment washout period prior to the first dose of trial treatment.
Exclusion Criteria
  • * Prior treatment with B7H3 targeted therapy.
  • * Prior treatment with antibody-drug conjugate with topoisomerase inhibitor.
  • * Is a candidate to locoregional treatment with potential to induce complete or near complete response and prolonged tumor control, per investigator's assessment.
  • * Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs.
Exclusion Criteria
  • * 1. Prior treatment with B7H3 targeted therapy.
  • * Prior treatment with antibody-drug conjugate with topoisomerase inhibitor.
  • * Is a candidate to locoregional treatment with potential to induce complete or near complete response and prolonged tumor control, per investigator's assessment.
  • * Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs.
  • * Has uncontrolled or significant cardiovascular disease.
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors

Location Details

NCT06953089

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, New York

Research Site USA04-0

New York, New York, United States, 10032

Not yet recruiting

United States, South Carolina

Research Site USA03-0

Charleston, South Carolina, United States, 29425

Not yet recruiting

Australia, New South Wales

Research Site AUS02-0

North Ryde BC, New South Wales, Australia, 2109

Not yet recruiting

China, Anhui

Research Site CHN09-0

Fairy, Anhui, China, 230022

Not yet recruiting

China, Beijing

Research Site CHN02-0

Beijing, Beijing, China, 100021

Not yet recruiting

China, Beijing

Research Site CHN03-0

Beijing, Beijing, China, 100142

Not yet recruiting

China, Heilongjiang

Research Site CHN08-0

Harbin, Heilongjiang, China, 150081

Not yet recruiting

China, Henan

Research Site CHN06-0

Zhengzhou, Henan, China, 450008

Not yet recruiting

China, Hubei

Research Site CHN05-0

Wuhan, Hubei, China, 430022

Not yet recruiting

China, Jiangxi

Research Site CHN07-0

Nanchang, Jiangxi, China, 330006

Not yet recruiting

China, Shanghai

Research Site CHN04-0

Shanghai, Shanghai, China, 200032

Not yet recruiting

China, Shanghai

Research Site CHN10-0

Shanghai, Shanghai, China, 200090

Not yet recruiting

Taiwan, Taipei

Research Site TWN02-0

New Taipei City, Taipei, Taiwan, 23561

Not yet recruiting

Taiwan, Taipei

Research Site TWN03-0

Taipei City, Taipei, Taiwan, 10002

Not yet recruiting

Taiwan, Taipei

Research Site TWN01-0

Taipei City, Taipei, Taiwan, 11217