RecruitingPhase 2NCT06953089

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

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

Sponsor

DualityBio Inc.

Enrollment

492 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

Solid Tumors

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests two new drug combinations for people with advanced or metastatic solid tumors, including liver cancer, cervical cancer, melanoma, ovarian cancer, head and neck cancer, and non-small cell lung cancer. Researchers are exploring whether combining experimental drugs (DB-1311 with BNT327 or DB-1305) can improve outcomes for patients who have limited treatment options. **You may be eligible if...** - You are 18 or older with an advanced solid tumor that has not responded to prior treatments - You have at least one measurable tumor - You are in reasonably good health and able to carry out daily activities - Depending on your cancer type, you meet specific criteria (e.g., liver cancer with preserved liver function, platinum-resistant ovarian cancer, recurrent cervical cancer, or advanced melanoma) **You may NOT be eligible if...** - Your organs are not functioning well enough to tolerate treatment - You have not had adequate time since your last cancer treatment - You do not meet the cancer-specific requirements for your tumor type Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDB-1311/BNT324

Administered I.V.

DRUGBNT327

Administered I.V.

DRUGDB-1305/BNT325

Administered I.V.

Locations(37)

USA06-0

Los Angeles, California, United States

USA16-0

Los Angeles, California, United States

USA01-0

Wheat Ridge, Colorado, United States

USA08-0

Florida City, Florida, United States

USA10-0

Atlanta, Georgia, United States

USA11-0

Bethesda, Maryland, United States

USA14-0

Lincoln, Nebraska, United States

USA04-0

New York, New York, United States

USA15-0

Portland, Oregon, United States

USA03-0

Charleston, South Carolina, United States

USA13-0

Anderson, Texas, United States

USA12-0

Houston, Texas, United States

USA05-0

Virginia Beach, Virginia, United States

USA09-0

Puyallup, Washington, United States

USA07-0

Spokane, Washington, United States

AUS07-0

North Sydney, New South Wales, Australia

AUS06-0

Benowa, Queensland, Australia

AUS04-0

Birtinya, Queensland, Australia

AUS05-0

Adelaide, South Australia, Australia

CHN02-0

Beijing, Beijing Municipality, China

CHN13-0

Beijing, Beijing Municipality, China

CHN23-0

Beijing, Beijing Municipality, China

CHN17-0

Dongguan, Guangdong, China

CHN06-0

Henan, Henan, China

CHN12-0

Xinxiang, Henan, China

CHN04-0

Hubei, Hubei, China

CHN26-0

Wuhan, Hubei, China

CHN34-0

Wuhan, Hubei, China

CHN11-0

Changsha, Hunan, China

CHN16-0

Xuzhou, Jiangsu, China

CHN35-0

Shenyang, Liaoning, China

CHN25-0

Xi'an, Shaanxi, China

CHN04-0

Shanghai, Shanghai Municipality, China

CHN01-0

Shanghai, Shanghai Municipality, China

CHN24-0

Chengdu, Sichuan, China

TWN01-0

Taipei, Taipei, Taiwan

TWN02-0

Taipei, Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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