A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: HER2-positive Advanced Solid Tumor

In brief

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.

Key facts

Study ID

NCT05150691

Run by

DualityBio Inc.

People needed

796

Starts

2022-01-31

Expected to finish

2027-10-01

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced/unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
• At least 1 measurable lesion (per RECIST 1.1)
• Provide signed informed consent
• ECOG performance status (PS) of 0-1.
• LVEF ≥ 50% by ECHO or MUGA
• Adequate organ functions
• Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing.
• Life expectancy of ≥ 3 months.
• Additional Inclusion Criteria for Part 2 Expansion Group 9:
• Has pathologically documented advanced/unresectable, recurrent, or metastatic EC (including UCS and USPC) and has progressed on or after at least 1 line of systemic treatment including platinum-based therapy and exposure to ICI but no more than prior 3 lines of therapy for advanced/unresectable, or metastatic disease. Note: endocrine therapy will not qualify as a systemic therapy line.

You may not qualify if…

• History of symptomatic CHF (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
• History of myocardial infarction or unstable angina within 6 months before Day 1.
• Average QTcF > 450 ms in males and > 470 ms in females
• History of clinically significant lung diseases
• Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
• HIV infection with AIDS defining illness or active viral hepatitis.
• Clinically active brain metastases
• Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline.
• A known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
• Part 2 (expansion) Only:Multiple primary malignancies within 3 years, except adequately resected non- melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.

Where it is running

• The First people's hospital of Yulin — Yulin, Guangxi, China (enrolling)
• Affiliated Hospital of Jiangnan University — Wuxi, Jiangsu, China (enrolling)
• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• Cancer Hospital of Guangxi Medical University — Nanning, Guangxi, China (enrolling)
• Union hospital Tongji Medical college Huazhong university of science and technology — Wuhan, Hubei, China (enrolling)
• Xiangya Hospital Central South University — Changsha, Hunan, China (enrolling)
• The Second Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
• The First Hospital of Jilin University — Hongcun, Changchun, China (enrolling)
• Gansu Provincial Maternity and Child-care Hospital — Lanzhou, Gansu, China (enrolling)
• The First affiliated hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
• Anyang Tumor Hospital — Anyang, Henan, China (enrolling)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
• Hunan People's Provincial Hospital — Changsha, Hunan, China (enrolling)
• The first affiliated hospital of Bengbu medical college — Bengbu, Anhui, China (enrolling)
• Anhui provincial hospital — Hefei, Anhui, China (enrolling)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
• Cancer Hospital Chinese Academy of Medical Science — Beijing, Beijing Municipality, China (enrolling)
• The First affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
• The First affiliated hospital of Xiamen University — Xiamen, Fujian, China (enrolling)
• Huizhou First Hospital — Guangzhou, Guangdong, China (enrolling)
• Sun Yat-Sen Memorial Hospital of Zhongshan University — Guangzhou, Guangdong, China (enrolling)
• Affiliated Hospital of Hebei University — Baoding, Hebei, China (enrolling)
• Henan cancer Hospital — Zhengzhou, Hehan, China (enrolling)
• The Affiliated Hospital of Xuzhou Medical College — Xuzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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