Clinical trial NCT06018337: A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
Official title: A Phase 3, Randomized, Multi-center, Open-Label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-Low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Metastatic Breast Cancer
Keywords: HER2-low
IHC 2+
BC
Breast Cancer
Lead sponsor: DualityBio Inc.
Sponsor class: INDUSTRY
Collaborators: name: BioNTech SE
First posted: 2023-08-30
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (immunohistochemistry \[IHC\]2+/in situ hybridization \[ISH\]- and IHC 1+) population.

Detailed description: The study is a Phase III, Randomized, Multi-center, Open-label study in HER2-low, HR+ metastatic breast cancer subjects whose disease has progressed on at least 2 lines of prior ET or within 6 months of first line ET + Cyclin-dependent kinase (CDK) 4/6 inhibitor in the metastatic setting. The primary purpose of the study is to determine the efficacy and safety of DB-1303/BNT323 compared with investigator's choice single agent chemotherapy in the target population. Approximately 532 subjects with HER2 IHC 2+/ISH- and IHC 1+ (HER2-low\] expression will be randomized 1:1 across approximately 255 centers globally to receive either DB-1303 or investigator's choice single agent chemotherapy (capecitabine, paclitaxel or nab-paclitaxel) until Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined disease progression (PD), unless there is unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.

Eligibility criteria: Inclusion Criteria:

1. 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).

2. Pathologically documented breast cancer that:

1. Is advanced or metastatic
2. Has HER2-low expression (IHC 1+ or IHC 2+/ISH-) as determined by the central laboratory result.
3. Was never previously reported as HER2-positive (IHC 3+ or ISH+) as per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.
4. Is documented as HR+ (either estrogen receptor \[ER\] and/or progesterone receptor \[PgR\] positive \[ER or PgR ≥1%\]) per ASCO/CAP guidelines (Allison et al 2020).

3. Must have an adequate tumor tissue sample available for assessment of HER2 by central laboratory, in formalin fixation and paraffin embedding (FFPE) blocks based on a mandatory FFPE tumor sample preferably obtained at the time of metastatic disease or later;

4. Eastern Cooperative Oncology Group performance status of 0 or 1.

5. Must have had either:

1. Disease progression on endocrine therapy + CDK4/6 inhibitor within 6 months of starting first line treatment for metastatic disease and considered appropriate for chemotherapy as the next treatment by the investigator, OR
2. Disease progression on at least 2 previous lines of ET with or without a targeted therapy (such as CDK4/6, mammalian target of rapamycin \[mTOR\] or phosphoinositide 3-kinase \[PI3-K\] inhibitors) administered for the treatment of metastatic disease.

6. No prior chemotherapy for advanced or metastatic breast cancer. Subjects who have received chemotherapy in the neo-adjuvant or adjuvant setting are eligible, as long as they have had a disease-free interval (defined as completion of systemic chemotherapy to diagnosis of advanced or metastatic disease) of \>12 months.

7. Life expectancy ≥12 weeks at screening.

8. Subjects must have at least one measurable lesion as defined per RECIST v1.1 (For bone only disease, subjects with lytic or mixed lytic bone lesions that can be measured by CT or MRI are eligible; subjects with sclerotic/osteoblastic bone lesions are not eligible).

9. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before randomization.

10. Adequate organ and bone marrow function within 14 days before randomization.

11. Has adequate treatment washout period before randomization.

12. Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. For women of childbearing potential, a negative result for serum pregnancy test (test must have a sensitivity of at least 25 mIU/mL) must be available at the screening visit and urine beta-human chorionic gonadotropin (β-HCG) pregnancy test prior to each administration of study treatment.

Women of childbearing potential are defined as those who are not surgically sterile (i.e., underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal.

13. Female subjects of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for 7 months after the last dose of study treatment. Not all methods of contraception are highly effective. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the subject for the duration of the study treatment and the drug washout period (7 months). Periodic abstinence (e.g., calendar ovulation, symptothermal, post ovulation methods), the rhythm method, and the withdrawal method are not acceptable methods of contraception. Female subjects must not donate ova, or retrieve for their own use, from the time of screening and throughout the study treatment period, and for at least 7 months after the last dose of study treatment. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to randomization in this study.

14. Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening and throughout the duration of the study treatment and the washout period (4 months after the last dose of DB-1303, 6 months after the last dose of paclitaxel or nab-paclitaxel, and 3 months after the last dose of capecitabine). Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the subject for the duration of the study treatment and the drug washout period. Periodic abstinence (e.g., calendar ovulation, symptothermal, post ovulation methods), the rhythm method, and the withdrawal method are not acceptable methods of contraception. It is strongly recommended for the female partners of a male subject also use at least one highly effective method of contraception throughout this period. In addition, male subjects should refrain from fathering a child or donating sperm throughout the duration of the study and the washout period (4 months after the last dose of DB-1303, 6 months after the last dose of paclitaxel or nab paclitaxel, and 3 months after the last dose of capecitabine). Preservation of sperm should be considered prior to randomization in this study.

15. Must be able and willing to comply with the protocol requirements and must sign and date the informed consent form prior to any screening evaluations.

Exclusion Criteria:

1. Ineligible for all options in the investigator's choice chemotherapy arm.
2. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events or compromise the ability of the subject to give written informed consent.
3. Clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring repeated drainage, peritoneal shunt or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to the randomization.
4. Uncontrolled or significant cardiovascular disease
5. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and radiation pneumonitis which needs glucocorticoids and antibiotics) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
6. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline or Grade ≤ 2 anemia.
7. Previous treatment with anti-HER2 therapy.
8. Prior treatment with antibody-drug conjugate that comprised an exatecan derivative that is a topoisomerase I inhibitor.
9. Prior randomization or treatment in a previous DB-1303/BNT323 study regardless of treatment assignment.
10. Has substance abuse or any other medical conditions such as psychological conditions, that may, in the opinion of the Investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.
11. Individuals who are dependent on the Sponsor, clinical site, or Investigator (e.g., is an employee of the Sponsor or the clinical trial site, a dependent of the Investigator, or any site staff member otherwise supervised by the Investigator).
12. Individuals who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities, in accordance with local regulations.

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

Primary outcomes:
measure: Progression-free survival (PFS) in the HR+, HER2-low population
timeFrame: Up to approximately 51 months
Secondary outcomes:
measure: Overall survival (OS) in the HR+, HER2-low population
timeFrame: Up to approximately 51 months
measure: Objective response rate (ORR) in the HR+, HER2-low population
timeFrame: Up to approximately 51 months
measure: PFS by Investigator assessment
timeFrame: Up to approximately 51 months
measure: Duration of response (DoR) in the HR+, HER2-low population
timeFrame: Up to approximately 51 months
measure: Treatment-emergent adverse events (TEAEs)
timeFrame: from the time of the subject signing the informed consent form (ICF) until the follow-up period is completed (35 days after the last dose of study treatment
measure: Serious adverse events (SAEs)
timeFrame: from the time of the subject signing the ICF until the follow-up period is completed (35 days after the last dose of study treatment
measure: Patient reported outcomes (PROs): European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - C30
timeFrame: Up to approximately 51 months
measure: Patient reported outcomes (PROs): EORTC QLQ-BR45
timeFrame: Up to approximately 51 months
measure: Patient reported outcomes (PROs): European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)
timeFrame: Up to approximately 51 months
measure: European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)
timeFrame: Up to approximately 51 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site 1141-0
state: Arizona
city: Fullerton
country: United States
facility: Research Site 1114-0
state: California
city: Los Angeles
country: United States
facility: Research Site 1107-0
state: California
city: Orange
country: United States
facility: Research Site 1118-0
state: California
city: Sacramento
country: United States
facility: Research Site 1143-0
state: California
city: Santa Barbara
country: United States
facility: Research Site 1132-0
state: California
city: Lone Tree
country: United States
facility: Research Site 1129-0
state: Colorado
city: Palm Bay
country: United States
facility: Research Site 1125-0
state: Florida
city: Savannah
country: United States
facility: Research Site 1110-0
state: Georgia
city: Chicago Ridge
country: United States
facility: Research Site 1124-0
state: Illinois
city: Merriam
country: United States
facility: Research Site 1106-0
state: Kansas
city: Louisville
country: United States
facility: Research Site 1104-0
state: Kentucky
city: Silver Spring
country: United States
facility: Research Site 1122-0
state: Maryland
city: Silver Spring
country: United States
facility: Research Site 8639-0
state: Maryland
city: Kansas City
country: United States
facility: Research Site 1109-0
state: Missouri
city: Florham Park
country: United States
facility: Research Site 1111-0
state: New Jersey
city: Westbury
country: United States
facility: Research Site 1105-0
state: New York
city: Chapel Hill
country: United States
facility: Research Site 1144-0
state: North Carolina
city: Akron
country: United States
facility: Research Site 1138-0
state: Ohio
city: Eugene
country: United States
facility: Research Site 1133-0
state: Oregon
city: Tigard
country: United States
facility: Research Site 1126-0
state: Oregon
city: Broomall
country: United States
facility: Research Site 1134-0
state: Pennsylvania
city: Horsham
country: United States
facility: Research Site 1123-0
state: Pennsylvania
city: Knoxville
country: United States
facility: Research Site 1149-0
state: Tennessee
city: Nashville
country: United States
facility: Research Site 1102-0
state: Tennessee
city: Dallas
country: United States
facility: Research Site 1101-0
state: Texas
city: Denison
country: United States
facility: Research Site 1116-0
state: Texas
city: Houston
country: United States
facility: Research Site 1115-0
state: Texas
city: San Antonio
country: United States
facility: Research Site 1117-0
state: Texas
city: Salt Lake City
country: United States
facility: Research Site 1130-0
state: Utah
city: Fairfax
country: United States
facility: Research Site 1108-0
state: Virginia
city: Fairfax
country: United States
facility: Research Site 1131-0
state: Virginia
city: Roanoke
country: United States
facility: Research Site 1127-0
state: Virginia
city: Rosario
country: Argentina
facility: Research Site 5401-0
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Research Site 5404-0
state: Tucuman
city: Camperdown
country: Australia
facility: Research Site 6108-0
state: New South Wales
city: Liverpool
country: Australia
facility: Research Site 6109-0
state: New South Wales
city: Sydney
country: Australia
facility: Research Site 6102-0
state: New South Wales
city: Birtinya
country: Australia
facility: Research Site 6106-0
state: Queensland
city: South Brisbane
country: Australia
facility: Research Site 6101-0
state: Queensland
city: Southport
country: Australia
facility: Research Site 6107-0
state: Queensland
city: Townsville
country: Australia
facility: Research Site 6104-0
state: Queensland
city: Adelaide
country: Australia
facility: Research Site 6110-0
state: South Australia
city: Bendigo
country: Australia
facility: Research Site 6103-0
state: Victoria
city: St. Albans
country: Australia
facility: Research Site 6105-0
state: Victoria
city: Brussels
country: Belgium
facility: Research Site 3201-0
city: Gent
country: Belgium
facility: Research Site 3204-0
city: Jette
country: Belgium
facility: Research Site 3205-0
city: Leuven
country: Belgium
facility: Research Site 3203-0
city: Liege
country: Belgium
facility: Research Site 3207-0
city: Roeselare
country: Belgium
facility: Research Site 3202-0
city: Brampton
country: Canada
facility: Research Site 1003-0
state: Ontario
city: Toronto
country: Canada
facility: Research Site 1001-0
state: Ontario
city: Montreal
country: Canada
facility: Research Site 1004-0
state: Quebec
city: Montreal
country: Canada
facility: Research Site 1005-0
state: Quebec
city: Montreal
country: Canada
facility: Research Site 1006-0
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site 1002-0
state: Quebec
city: Hefei
country: China
facility: Research Site 8640-0
state: Anhui
city: Hefei
country: China
facility: Research Site 8614-0
state: Anhui
city: Beijing
country: China
facility: Research Site 8601-0
state: Beijing
city: Beijing
country: China
facility: Research Site 8625-0
state: Beijing
city: Chongqing
country: China
facility: Research Site 8627-0
state: Chongqing
city: Fuzhou
country: China
facility: Research Site 8651-0
state: Fujian
city: Xiamen
country: China
facility: Research Site 8638-0
state: Fujian
city: Lanzhou
country: China
facility: Research Site 8630-0
state: Gansu
city: Guangzhou
country: China
facility: Research Site 8604-0
state: Guangdong
city: Guangzhou
country: China
facility: Research Site 8628-0
state: Guangdong
city: Huizhou
country: China
facility: Research Site 8621-0
state: Guangdong
city: Zhuhai
country: China
facility: Research Site 8622-0
state: Guangdong
city: Nanning
country: China
facility: Research Site 8615-0
state: Guangxi
city: Baoding
country: China
facility: Research Site
state: Hebei
city: Baoding
country: China
facility: Research Site 8629-0
state: Hebei
city: Shijiazhuang
country: China
facility: Research Site 8645-0
state: Hebei
city: Harbin
country: China
facility: Research Site 8619-0
state: Heilongjiang
city: Anyang
country: China
facility: Research Site 8649-0
state: Henan
city: Luoyang
country: China
facility: Research Site 8609-0
state: Henan
city: Weihui
country: China
facility: Research Site 8648-0
state: Henan
city: Zhengzhou
country: China
facility: Research Site 8605-0
state: Henan
city: Zhengzhou
country: China
facility: Research Site 8623-0
state: Henan
city: Wuhan
country: China
facility: Research Site 8637-0
state: Hubei
city: Wuhan
country: China
facility: Research Site 8608-0
state: Hubei
city: Xiangyang
country: China
facility: Research Site 8633-0
state: Hubei
city: Changsha
country: China
facility: Research Site 8635-0
state: Hunan
city: Yongzhou
country: China
facility: Research Site 8654-0
state: Hunan
city: Huai'an
country: China
facility: Research Site 8646-0
state: Jiangsu
city: Nanjing
country: China
facility: Research Site 8607-0
state: Jiangsu
city: Xuzhou
country: China
facility: Research Site 8624-0
state: Jiangsu
city: Nanchang
country: China
facility: Research Site 8631-0
state: Jiangxi
city: Changchun
country: China
facility: Research Site 8612-0
state: Jilin
city: Changchun
country: China
facility: Research Site 8618-0
state: Jilin
city: Changchun
country: China
facility: Research Site 8644-0
state: Jilin
city: Dalian
country: China
facility: Research Site 8636-0
state: Liaoning
city: Dalian
country: China
facility: Research Site-8636-0
state: Liaoning
city: Shenyang
country: China
facility: Research Site 8643-0
state: Liaoning
city: Shenyang
country: China
facility: Research Site 8642-0
state: Liaoning
city: Jinan
country: China
facility: Research Site 8634-0
state: Shandong
city: Jining
country: China
facility: Research Site 8613-0
state: Shandong
city: Linyi
country: China
facility: Research Site 8610-0
state: Shandong
city: Weihai
country: China
facility: Research Site 8650-0
state: Shandong
city: Shanghai
country: China
facility: Research Site 8603-0
state: Shanghai
city: Shanghai
country: China
facility: Research Site 8602-0
state: Shanghai
city: Xi'an
country: China
facility: Research Site 8611-0
state: Shanxi
city: Chengdu
country: China
facility: Research Site 8606-0
state: Sichuan
city: Neijiang
country: China
facility: Research Site 8626-0
state: Sichuan
city: Zigong
country: China
facility: Research Site 8647-0
state: Sichuan
city: Tianjin
country: China
facility: Research Site 8617-0
state: Tianjin
city: Urumqi
country: China
facility: Research Site 8616-0
state: Xinjiang
city: Kunming
country: China
facility: Research Site 8632-0
state: Yunnan
city: Hangzhou
country: China
facility: Research Site 8652-0
state: Zhejiang
city: Hangzhou
country: China
facility: Research Site 8620-0
state: Zhejiang
city: Hangzhou
country: China
facility: Research Site 8641-0
state: Zhejiang
city: Marseille cedex 20
country: France
facility: Research Site 3311-0
state: Bouches-du-Rhône
city: La Rochelle cedex
country: France
facility: Research Site 3303-0
state: Charente Maritime
city: Besancon Cedex
country: France
facility: Research Site 3312-0
state: Doubs
city: Nimes
country: France
facility: Research Site 3308-0
state: Gard
city: Bordeaux
country: France
facility: Research Site 3314-0
state: Gironde
city: Toulouse cedex 09
country: France
facility: Research Site 3305-0
state: Haute Garonne
city: Limoges
country: France
facility: Research Site 3309-0
state: Haute Vienne
city: Montpellier
country: France
facility: Research Site 3304-0
state: Herault
city: Saint Herblain
country: France
facility: Research Site 3310-0
state: Loire Atlantique
city: Angers Cedex 2
country: France
facility: Research Site 3301-0
state: Maine Et Loire
city: Lille cedex
country: France
facility: Research Site 3315-0
state: Nord
city: Bayonne cedex
country: France
facility: Research Site 3306-0
state: Pyrenees Atlantiques
city: Pierre Benite cedex
country: France
facility: Research Site 3318-0
state: Rhone
city: Rouen
country: France
facility: Research Site 3313-0
state: Seine Maritime
city: Avignon Cedex 9
country: France
facility: Research Site 3307-0
state: Vaculuse
city: Creteil Cedex
country: France
facility: Research Site 3302-0
state: Val De Marne
city: Paris
country: France
facility: Research Site 3316-0
city: Bottrop
country: Germany
facility: Research Site 4904-0
state: Nordrhein Westfalen
city: Hong Kong
country: Hong Kong
facility: Research Site 8501-0
city: Hong Kong
country: Hong Kong
facility: Research Site 8503-0
city: Hong Kong
country: Hong Kong
facility: Research Site 8502-0
city: Hong Kong
country: Hong Kong
facility: Research Site 8505-0
city: Budapest
country: Hungary
facility: Research Site 3603-0
city: Gyor
country: Hungary
facility: Research Site 3606-0
city: Kecskemet
country: Hungary
facility: Research Site 3604-0
city: Salgotarjan
country: Hungary
facility: Research Site 3602-0
city: Tatabanya
country: Hungary
facility: Research Site 3607-0
city: Jerusalem
country: Israel
facility: Research Site 9702-0
city: Kfar-Saba
country: Israel
facility: Research Site 9703-0
city: Petach-Tikva
country: Israel
facility: Research Site 9704-0
city: Rehovot
country: Israel
facility: Research Site 9705-0
city: Bergamo
country: Italy
facility: Research Site 3908-0
city: Brescia
country: Italy
facility: Research Site 3907-0
city: Catania
country: Italy
facility: Research Site 3901-0
city: Catanzaro
country: Italy
facility: Research Site 3903-0
city: Milano
country: Italy
facility: Research Site 3906-0
city: Milano
country: Italy
facility: Research Site 3911-0
city: Milano
country: Italy
facility: Research Site 3904-0
city: Napoli
country: Italy
facility: Research Site 3909-0
city: Verona
country: Italy
facility: Research Site 3905-0
city: Wonju
country: Korea, Republic of
facility: Research Site 8211-0
state: Gangwon-do
city: Seongnam
country: Korea, Republic of
facility: Research Site 8204-0
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Research Site 8201-0
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Research Site 8202-0
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Research Site 8208-0
city: Incheon
country: Korea, Republic of
facility: Research Site 8209-0
city: Seoul
country: Korea, Republic of
facility: Research Site 8207-0
city: Seoul
country: Korea, Republic of
facility: Research Site 8206-0
city: Seoul
country: Korea, Republic of
facility: Research Site 8210-0
city: Seoul
country: Korea, Republic of
facility: Research Site 8203-0
city: Seoul
country: Korea, Republic of
facility: Research Site 8205-0
city: Rzeszów
country: Poland
facility: Research Site 4802-0
city: Torun
country: Poland
facility: Research Site 4807-0
city: Łódź
country: Poland
facility: Research Site 4803-0
city: Sant Cugat del Valles
country: Spain
facility: Research Site 3403-0
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Research Site 3409-0
state: La Coruña
city: Majadahonda
country: Spain
facility: Research Site 3406-0
state: Madrid
city: Barcelona
country: Spain
facility: Research Site 3410-0
city: Barcelona
country: Spain
facility: Research Site 3402-0
city: Barcelona
country: Spain
facility: Research Site 3404-0
city: Madrid
country: Spain
facility: Research Site 3416-0
city: Madrid
country: Spain
facility: Research Site 3407-0
city: Madrid
country: Spain
facility: Research Site 3414-0
city: Madrid
country: Spain
facility: Research Site 3401-0
city: Málaga
country: Spain
facility: Research Site 3415-0
city: Sevilla
country: Spain
facility: Research Site 3408-0
city: Sevilla
country: Spain
facility: Research Site 3413-0
city: Valencia
country: Spain
facility: Research Site 3412-0
city: Truro
country: United Kingdom
facility: Research Site 4404-0
state: Cornwall
city: London
country: United Kingdom
facility: Research Site 4408-0
state: Greater London
city: London
country: United Kingdom
facility: Research Site 4409-0
state: Greater London
city: Manchester
country: United Kingdom
facility: Research Site 4402-0
state: Greater Manchester
city: Leeds
country: United Kingdom
facility: Research Site 4407-0
state: West Yorkshire
city: Nottingham
country: United Kingdom
facility: Research Site 4401-0
Study officials:
affiliation: DualityBio Inc.
name: Lily Hu
role: STUDY_DIRECTOR
References: