A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors

NCT05914116 | Recruiting Phase 1 FDA Drug

• 1 other identifier: DB-1311-O-1001
• Study Type: interventional
• Target: 862
• Locations: 4 countries
• Sites: 107

Brief Summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.

Conditions

Advanced Solid Tumors

Keywords

B7-H3; SCLC (small cell lung cancer); NSCLC (non-small cell lung cancer); ESCC (esophageal squamous cell carcinoma); CRPC (castration-resistant prostate cancer); Melanoma; HCC (Hepatocellular Carcinoma); HNSCC (Head and neck squamous cell carcinomas); CC (Cervical Cancer); PROC (platinum-resistant ovarian cancer); PC (prostate cancer); CSPC (castration-sensitive prostate cancer)

Outcome Measures

Primary Outcomes (11)

• Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Percentage of participants in Part 1 with DLTs

  Percentage of participants in Part 1 with DLTs

  up to 21 days after Cycle 1 Day 1

• Phase 1& Phase 2a: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.

  Percentage of participants with TEAEs graded according to National Cancer Institute (NCI) CTCAE v5.0

  Up to follow-up period, approximately 1 year post-treatment

• Phase 1& Phase 2a: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.

  Percentage of Participants with SAEs graded according to NCI CTCAE v5.0

  Up to follow-up period, approximately 1 year post-treatment

• Phase 1 & Phase 2a: vital sign measurements

  Up to follow-up period, approximately 1 year post-treatment

• Phase 1& Phase 2a: clinical safety laboratory parameters

  Up to follow-up period, approximately 1 year post-treatment

• Phase 1& Phase 2a: Electrocardiogram (ECG) parameters

  Up to follow-up period, approximately 1 year post-treatment

• Phase 1& Phase 2a: Eastern Cooperative Oncology Group (ECOG) performance status (PS)

  Up to follow-up period, approximately 1 year post-treatment

• Phase 1& Phase 2a: left ventricular ejection fraction (LEVF)

  Up to follow-up period, approximately 1 year post-treatment

• Phase 1: Maximum Tolerated Dose (MTD) of DB-1311/BNT324

  MTD on the data collected during Part 1

  Up to the completion of Part 1 (assessed up to 12 months)

• Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1311/BNT324

  RP2D of DB-1311/BNT324 based on the data collected during Part 1

  Up to the completion of Part 1 (assessed up to 12 months)

• Phase 2a: Objective Response Rate (ORR) as determined by investigator

  Objective Response Rate (ORR) as determined by investigator per RECIST 1.1 in non-PC/non-GBM participants per RECIST v1.1 for soft tissue and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases in PC participants, and ORR per neuro-oncology 2.0 (RANO 2.0) criteria in GBM participants.

  Up to follow-up period, approximately 1 year post-treatment

Secondary Outcomes (15)

• Phase 1: Objective response rate (ORR)

  Up to follow-up period, approximately 1 year post-treatment

• Phase 1 & Phase 2a: duration of response (DoR)

  Up to follow-up period, approximately 1 year post-treatment

• Phase 1 & Phase 2a: disease-control rate (DCR)

  Up to follow-up period, approximately 1 year post-treatment

• Phase 1 & Phase 2a: Time to Response (TTR)

  Up to follow-up period, approximately 1 year post-treatment

• Phase 1 & Phase 2a: Progression Free Survival (PFS)

  Up to follow-up period, approximately 1 year post-treatment

Study Arms (23)

DB-1311/BNT324 Dose Level 1

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 1 on Day 1 of each cycle Q3W (every 3 weeks)

Drug: DB-1311

DB-1311/BNT324 Dose Level 2

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 2 on Day 1 of each cycle Q3W

Drug: DB-1311

DB-1311/BNT324 Dose Level 3

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 3 on Day 1 of each cycle Q3W

Drug: DB-1311

DB-1311/BNT324 Dose Level 4

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 4 on Day 1 of each cycle Q3W

Drug: DB-1311

DB-1311/BNT324 Dose Level 5

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 5 on Day 1 of each cycle Q3W

Drug: DB-1311

DB-1311/BNT324 Dose Expansion 1

EXPERIMENTAL

Subjects with advanced/unresectable, or metastatic SCLC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2.

Drug: DB-1311

DB-1311/BNT324 Dose Expansion 2

EXPERIMENTAL

Subjects with advanced/unresectable, or metastatic NSCLC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2.

Drug: DB-1311

DB-1311/BNT324 Dose Expansion 3

EXPERIMENTAL

Subjects with advanced/unresectable, or metastatic ESCC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Drug: DB-1311

DB-1311/BNT324 Dose Expansion 4

EXPERIMENTAL

Subjects with advanced/unresectable, or metastatic CRPC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2.

Drug: DB-1311

DB-1311/BNT324 Dose Expansion 5

EXPERIMENTAL

Subjects with advanced/unresectable, or metastatic melanoma who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Drug: DB-1311

DB-1311/BNT324 Dose Expansion 6

EXPERIMENTAL

Subjects with advanced/unresectable, or metastatic HCC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Drug: DB-1311

DB-1311/BNT324 Dose Expansion 7

EXPERIMENTAL

Subjects with advanced/unresectable, or metastatic cervical cancer who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Drug: DB-1311

DB-1311/BNT324 Dose Expansion 8

EXPERIMENTAL

Subjects with other advanced or metastatic solid tumors who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Drug: DB-1311

DB-1311/BNT324 Dose Expansion 9

EXPERIMENTAL

Subjects with advanced/unresectable, or metastatic HNSCC (not including nasopharyngeal carcinoma \[NPC\]) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Drug: DB-1311

DB-1311/BNT324 Dose Expansion 10

EXPERIMENTAL

Subjects with advanced or metastatic rare tumor types who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Drug: DB-1311

DB-1311/BNT324 Dose Expansion 11

EXPERIMENTAL

Subjects with metastatic CRPC who have progressed on or after standard systemic treatments including no more than 2 lines of systemic chemotherapy, novel hormone therapy and lutetium-177 radioligand therapy, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Drug: DB-1311

DB-1311/BNT324 Dose Expansion 12

EXPERIMENTAL

Taxane-naive subjects with metastatic CRPC who have progressed on or after novel hormone therapy, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Drug: DB-1311

DB-1311/BNT324 Dose Expansion 13

EXPERIMENTAL

Subjects with advanced/unresectable, or metastatic HNSCC (not including NPC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.

Drug: DB-1311

DB-1311/BNT324 Dose Expansion 14

EXPERIMENTAL

Subjects with epithelial OC who have had 1-3 prior lines of systemic treatment and are platinum-resistant, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2.

Drug: DB-1311

DB-1311/BNT324 Dose Expansion 15

EXPERIMENTAL

Subjects with Subjects with advanced/unresectable, or metastatic melanoma, ESCC, PROC and CC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via IV will be used for DB-1311/BNT324. Lopinavir and ritonavir/ Itraconazole will be administered orally twice a day/ once a day.

Drug: DB-1311; Drug: Lopinavir and Ritonavir Tablets; Drug: itraconazole

DB-1311/BNT324 Dose Expansion 16

EXPERIMENTAL

Taxane-naive subjects with metastatic CRPC who have progressed on or after NHT, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324, combined with enzalutamide 160mg QD orally.

Drug: DB-1311; Drug: Enzalutamide

DB-1311/BNT324 Dose Expansion 17

EXPERIMENTAL

Taxane-naive subjects with metastatic CRPC who have progressed on or after NHT, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324, combined with abiraterone 1000mg QD orally.

Drug: DB-1311; Drug: Abiraterone

DB-1311/BNT324 Dose Expansion 18

EXPERIMENTAL

CSPC subjects with suboptimal PSA response to ADT/NHT, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324, combined with enzalutamide 160mg or abiraterone 1000mg QD orally.

Drug: DB-1311; Drug: Enzalutamide; Drug: Abiraterone

Interventions

DB-1311 DRUG

Administered I.V.(intravenous infusion)

DB-1311/BNT324 Dose Expansion 1; DB-1311/BNT324 Dose Expansion 10; DB-1311/BNT324 Dose Expansion 11; DB-1311/BNT324 Dose Expansion 12; DB-1311/BNT324 Dose Expansion 13; DB-1311/BNT324 Dose Expansion 14; DB-1311/BNT324 Dose Expansion 15; DB-1311/BNT324 Dose Expansion 16; DB-1311/BNT324 Dose Expansion 17; DB-1311/BNT324 Dose Expansion 18; DB-1311/BNT324 Dose Expansion 2; DB-1311/BNT324 Dose Expansion 3; DB-1311/BNT324 Dose Expansion 4; DB-1311/BNT324 Dose Expansion 5; DB-1311/BNT324 Dose Expansion 6; DB-1311/BNT324 Dose Expansion 7; DB-1311/BNT324 Dose Expansion 8; DB-1311/BNT324 Dose Expansion 9; DB-1311/BNT324 Dose Level 1; DB-1311/BNT324 Dose Level 2; DB-1311/BNT324 Dose Level 3; DB-1311/BNT324 Dose Level 4; DB-1311/BNT324 Dose Level 5

Lopinavir and Ritonavir Tablets DRUG

Lopinavir and Ritonavir Tablets

DB-1311/BNT324 Dose Expansion 15

itraconazole DRUG

itraconazole

DB-1311/BNT324 Dose Expansion 15

Enzalutamide DRUG

oral administration

DB-1311/BNT324 Dose Expansion 16; DB-1311/BNT324 Dose Expansion 18

Abiraterone DRUG

oral administration

DB-1311/BNT324 Dose Expansion 17; DB-1311/BNT324 Dose Expansion 18

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment; 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 (measurable disease as defined by RANO 2.0 criteria for GBM subjects). Castrate-resistant prostate cancer (CRPC) subjects with bone only disease may be eligible on a case-by- case basis after discussion with the Medical Monitor.
• 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 function 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 B7-H3 level and other biomarkers if no contraindication.
• Note: there is no minimum B7-H3 expression level mandatory for entry into the study.
• 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.
• Male and female subjects of reproductive/childbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) during the study and for at least 4 months and 7 months after the last dose of study drug, respectively.
• Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration.
• Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.
• SCLC subjects (Phase 2a Cohort 1 ONLY):

You may not qualify if:

• Prior treatment with B7-H3 targeted therapy.
• Prior treatment with antibody drug conjugate with topoisomerase inhibitor (e.g., trastuzumab deruxtecan).
• 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.
• Use of concomitant medications known to prolong the QT interval. If the use is deemed necessary, they should be administered with caution and closely monitoring the QT interval, after discussed with the Sponsor.
• 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 a history of underlying pulmonary disorder including, but not limited to, pulmonary emboli within 3 months of the start of study treatment, severe asthma, severe COPD, restrictive lung disease, and other clinically significant pulmonary compromise or requirement for supplemental oxygen.
• Clinically significant gastrointestinal disorder including, but not limited to, history of gastrointestinal fistulation that need long-term intravenous nutrition; gastrointestinal dysfunction that need long-term enteral nutrition through the tube feeding; gastrointestinal obstruction/perforation that not recovered within 6 months prior to the enrollment.
• Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk of bleeding; A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment (Only applicable to HCC patients).
• Metastatic disease that involves major airways or blood vessels (e.g., patients with vascular invasion of the major portal vein and inferior vena cava).
• Clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to the enrollment.
• Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjögren's, sarcoidosis) where there is documented, or a suspicion of pulmonary involvement at the time of screening.
• Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.
• Know human immunodeficiency virus (HIV) infection.

Sponsors & Collaborators

• DualityBio Inc.: lead
• BioNTech SE: collaborator

Study Sites (107)

Research Site 111

Tucson, Arizona, 85711, United States

RECRUITING

Research Site 125

Los Angeles, California, 90033, United States

RECRUITING

Research Site 133

Los Angeles, California, 90067, United States

RECRUITING

Research Site 103

Los Angeles, California, 90095, United States

RECRUITING

Research Site 128

Santa Monica, California, 90403, United States

RECRUITING

Research Site 118

Celebration, Florida, 34747, United States

RECRUITING

Research Site 127

Margate, Florida, 33063, United States

RECRUITING

Research Site 137

Orlando, Florida, 32827, United States

RECRUITING

Research Site 101

Plantation, Florida, 33322, United States

RECRUITING

Research Site 109

Tamarac, Florida, 33321, United States

RECRUITING

Research Site 114

Atlanta, Georgia, 30318, United States

RECRUITING

Research Site 139

Atlanta, Georgia, 30322, United States

RECRUITING

Research Site 115

Louisville, Kentucky, 40202, United States

RECRUITING

Research Site 129

Detroit, Michigan, 48201, United States

RECRUITING

Research Site 121

Saint Paul, Minnesota, 55101, United States

RECRUITING

Research Site 110

Las Vegas, Nevada, 89169, United States

RECRUITING

Research Site 107

New York, New York, 10032, United States

RECRUITING

Research Site 138

Canton, Ohio, 44718, United States

RECRUITING

Research Site 113

Cincinnati, Ohio, 45267, United States

RECRUITING

Research Site 131

Dayton, Ohio, 45409, United States

RECRUITING

Research Site 123

Charleston, South Carolina, 29425, United States

RECRUITING

Research Site 108

Greenville, South Carolina, 29607, United States

RECRUITING

Research Site 136

Nashville, Tennessee, 37203, United States

RECRUITING

Research Site 135

Austin, Texas, 78731, United States

RECRUITING

Research Site 120

Dallas, Texas, 75390, United States

RECRUITING

Research Site 102

Fairfax, Virginia, 22031, United States

RECRUITING

Research Site 112

Fairfax, Virginia, 22031, United States

RECRUITING

Research Site 105

Spokane, Washington, 99208, United States

RECRUITING

Research Site 208

Blacktown, New South Wales, 2148, Australia

RECRUITING

Research Site 215

Camperdown, New South Wales, 2050, Australia

RECRUITING

Research Site 212

Concord, New South Wales, 2139, Australia

RECRUITING

Research Site 217

New Lambton Heights, New South Wales, 2305, Australia

RECRUITING

Research Site 201

Sydney, New South Wales, 2031, Australia

RECRUITING

Research Site 205

Sydney, New South Wales, 2109, Australia

RECRUITING

Research Site 206

Sydney, New South Wales, 2228, Australia

RECRUITING

Research Site 216

Waratah, New South Wales, 2298, Australia

RECRUITING

Research Site 209

Birtinya, Queensland, 4575, Australia

RECRUITING

Research Site 203

Brisbane, Queensland, 4102, Australia

RECRUITING

Research Site 210

Gold Coast, Queensland, 4224, Australia

RECRUITING

Research Site 202

Nedlands, Western Australia, 6009, Australia

RECRUITING

Research Site 207

Nedlands, Western Australia, 6009, Australia

RECRUITING

Research Site 319

Hefei, Anhui, 230031, China

RECRUITING

Research Site 365

Beijing, Beijing Municipality, 100034, China

RECRUITING

Research Site 310

Beijing, Beijing Municipality, 100142, China

RECRUITING

Research Site 337

Beijing, Beijing Municipality, 100142, China

RECRUITING

Research Site 327

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Research Site 345

Chongqing, Chongqing Municipality, 400072, China

RECRUITING

Research Site 353

Chongqing, Chongqing Municipality, 400072, China

RECRUITING

Research Site 356

Chongqing, Chongqing Municipality, 400072, China

RECRUITING

Research Site 313

Fuzhou, Fujian, 350001, China

RECRUITING

Research Site 314

Guangzhou, Guangdong, 510060, China

RECRUITING

Research Site 322

Guangzhou, Guangdong, 510060, China

RECRUITING

Research site 367

Guangzhou, Guangdong, 510120, China

RECRUITING

Research Site 346

Guangzhou, Guangdong, 510282, China

RECRUITING

Research Site 348

Guangzhou, Guangdong, 510300, China

RECRUITING

Research Site 350

Guangzhou, Guangdong, 510515, China

RECRUITING

Research Site 360

Nanning, Guangxi, 530021, China

RECRUITING

Research Site 334

Baoding, Hebei, 071030, China

RECRUITING

Research Site 315

Harbin, Heilongjiang, 150081, China

RECRUITING

Research Site 316

Luoyang, Henan, 450000, China

RECRUITING

Research Site 317

Xinxiang, Henan, 453100, China

RECRUITING

Research Site 306

Zhengzhou, Henan, 450000, China

RECRUITING

Research Site 304

Zhengzhou, Henan, 450052, China

RECRUITING

Research Site 321

Wuhan, Hubei, 430000, China

RECRUITING

Research Site 311

Wuhan, Hubei, 430030, China

RECRUITING

Research Site 309

Changsha, Hunan, 410031, China

RECRUITING

Research Site 323

Changsha, Hunan, 410031, China

RECRUITING

Research Site 344

Nanjing, Jiangsu, 210008, China

RECRUITING

Research Site 305

Nanjing, Jiangsu, 21000, China

RECRUITING

Research Site 307

Ganzhou, Jiangxi, 341000, China

RECRUITING

Research Site 349

Nanchang, Jiangxi, 330006, China

RECRUITING

Research Site 361

Nanchang, Jiangxi, 330029, China

RECRUITING

Research Site 328

Changchun, Jilin, 130000, China

RECRUITING

Research Site 301

Changchun, Jilin, 130012, China

RECRUITING

Research Site 320

Shenyang, Liaoning, 110000, China

RECRUITING

Research Site 352

Shenyang, Liaoning, 110042, China

RECRUITING

Research Site 363

Nanjing, Nanjing, 210006, China

RECRUITING

Research Site 340

Jinan, Shandong, 250013, China

RECRUITING

Research Site 308

Jinan, Shandong, 250117, China

RECRUITING

Research Site 333

Linyi, Shandong, 276000, China

RECRUITING

Research Site 302

Linyi, Shandong, 276034, China

RECRUITING

Research Site 335

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Research Site 326

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Research Site 355

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Research Site 332

Xi’an, Shanxi, 710000, China

RECRUITING

Research Site 312

Chengdu, Sichuan, 610041, China

RECRUITING

Research Site 330

Chengdu, Sichuan, 610041, China

RECRUITING

Research Site 366

Chengdu, Sichuan, 610041, China

RECRUITING

Research Site 325

Chengdu, Sichuan, 610072, China

RECRUITING

Research Site 347

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

Research Site 318

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Research site 368

Tianjin, Tianjin Municipality, 300300, China

RECRUITING

Research Site 324

Hangzhou, Zhejiang, 310014, China

RECRUITING

Research Site 329

Hangzhou, Zhejiang, 310016, China

RECRUITING

Research Site 331

Hangzhou, Zhejiang, 310022, China

RECRUITING

Research Site 359

Hangzhou, Zhejiang, 310022, China

RECRUITING

Research site 369

Hangzhou, Zhejiang, 310022, China

RECRUITING

Research Site 303

Taizhou, Zhejiang, 317099, China

RECRUITING

Research Site 408

Kaohsiung City, 807377, Taiwan

RECRUITING

Research Site 405

Kaohsiung City, 824005, Taiwan

RECRUITING

Research Site 406

New Taipei City, 235041, Taiwan

RECRUITING

Research Site 401

Taipei, 100225, Taiwan

RECRUITING

Research Site 402

Taipei, 100225, Taiwan

RECRUITING

Research Site 409

Taipei, 104217, Taiwan

RECRUITING

Research Site 403

Taipei, 110301, Taiwan

RECRUITING

Research Site 407

Taipei, 112201, Taiwan

RECRUITING

Research Site 404

Taoyuan District, 333423, Taiwan

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung; Esophageal Squamous Cell Carcinoma; Melanoma; Carcinoma, Hepatocellular; Squamous Cell Carcinoma of Head and Neck; Uterine Cervical Neoplasms; Prostatic Neoplasms

Interventions

Lopinavir; Ritonavir; Itraconazole; enzalutamide; abiraterone

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Liver Neoplasms; Liver Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Triazoles; Piperazines

Study Officials

• Lily Hu

  DualityBio Inc.

  STUDY DIRECTOR

Central Study Contacts

Ling Li

CONTACT

86-21-26018730; ling.li@dualitybiologics.com

Tiana Zhao

CONTACT

tiana.zhao@dualitybiologics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: August 17, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (28); AU (13); CN (57); TW (9)