A Study of DB-1310 in Advanced/Metastatic Solid Tumors

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1310 in Subjects With Advanced/Metastatic Solid Tumors

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: Osimertinib; Drug: capecitabine; Drug: DB-1310; Drug: Trastuzumab

Detailed Description

This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts the standard "3+3" design to identify: the MTD and/or RP2D of DB-1310 as monotherapy, the RCD_A of DB-1310 in combination with trastuzumab or approved trastuzumab biosimilar and the RCD_B of DB-1310 in combination with Osimertinib; Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1310 as monotherapy or in combination with trastuzumab or approved trastuzumab biosimilar or in combination with Osimertinib, or in combination with capecitabine

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Tiana Zhao; Phone Number: 1-626-433-3820; Email: tiana.zhao@dualitybiologics.com
• Study Contact Backup: Name: Lingling Gu; Email: lingling.gu@dualitybiologics.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Qiming Wang
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Hunan Cancer Hospital
      • Contact: Lin Wu
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Jiangsu Province Hospital
      • Contact: Yong mei Yin
    • Wuxi, Jiangsu, China, 214000
      • Recruiting
      • Affiliated Hospital of Jiangnan University
      • Contact: Yong Mao
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Jiuwei Cui
  • Liaoning
    • Shenyang, Liaoning, China, 110010
      • Recruiting
      • The First Hospital of China Medical University
      • Contact: Ming fang Zhao
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Shun Lu
  • Sichuan
    • Chengdu, Sichuan, China, 610030
      • Recruiting
      • Sichuan Provincial People's Hospital
      • Contact: Haitao Lan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Research Site 222
• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California, Davis Comprehensive Cancer Center
      • Contact: Tianhong Li, PhD
    • Santa Monica, California, United States, 90404
      • Recruiting
      • UCLA Hematology/Oncology - Santa Monica
      • Contact: Aaron E. Lisberg, MD
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Withdrawn
      • Research Site 117
    • Margate, Florida, United States, 33063
      • Withdrawn
      • D&H Cancer Research Center LLC
    • Orlando, Florida, United States, 32827
      • Recruiting
      • Sarah Cannon Research Institute at Florida Cancer Specialists
      • Contact: Cesar Batista, MD
    • Plantation, Florida, United States, 33322
      • Recruiting
      • BRCR Global
      • Contact: H Amin, MD
    • Sarasota, Florida, United States, 34232
      • Recruiting
      • Florida Cancer Specialists
      • Contact: Judy SZ Wang, MD
    • Tamarac, Florida, United States, 33321
      • Recruiting
      • BRCR Medical Center Inc.
      • Contact: Chintan Gandhi
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Research Site 111
      • Contact: Jacqueline Brown, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Julia Rotow, MD
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health System
      • Contact: Amy Weise, DO
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Active, not recruiting
      • Research Site 119
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
      • Contact: Brittany-Belle Gordon, MD,
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Oncology, PLLC
      • Contact: Erika P. Hamilton, MD
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • NEXT Virginia
      • Contact: A Spira, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. Have relapsed or progressed on or after standard systemic treatments, or intolerable with standard treatment, or for which no standard treatment is available. Documented radiological disease progression during/after most recent treatment regimen for advanced/unresectable, or metastatic disease.
3. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
4. Has a life expectancy of ≥ 3 months.
5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
6. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
7. Is willing to provide archived tumor tissue or undergo fresh tumor biopsy for the retrospective measurement of human epidermal growth factor receptor 3 (HER3) level and other biomarkers if no contraindication. For HER2 IHC 0 breast cancer subjects, it is highly recommended to collect additional tumor sample (Refer to Lab Manual).
8. 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.

9. 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.

   Females must be using highly effective contraceptive measures during the study and for at least 7 months after the last dosing of study drug, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:

   • Post-menopausal defined as aged 50 years or more and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
   • Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution
   • Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
10. 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.
11. 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.

12. Phase 1 monotherapy subjects (Phase 1 monotherapy ONLY):

    • Pathologically documented advanced/unresectable, or metastatic solid tumors that is refractory to or intolerable with standard treatment, or for which standard treatment is not available.

Exclusion Criteria

1. Prior treatment with HER3 targeted therapy.
2. Prior treatment with antibody drug conjugate with topoisomerase I inhibitor (except topoisomerase I inhibitor HER2 ADC for backfilled subjects in Combo A of Phase 1 and subjects in Cohort 2e of Phase 2a, and not applicable for subjects enrolled for DLT observation in Phase 1).
3. Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
4. Has a medical history of myocardial infarction or unstable angina or cerebrovascular accident including transient ischemic attack (TIA) within 6 months before first dose. Or has uncontrolled hypertension (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg).
5. Has any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG), e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval > 250 milliseconds (ms).
6. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to > 470 millisecond (ms) based on a 12-lead electrocardiogram (ECG) in triplicate.

7. Unable or unwilling to discontinue concomitant drugs that are known to prolong the QT interval.

   For Combo B of Phase 1 and Cohort 2g, 2k of Phase 2a, patients currently receiving (or unable to stop use prior to receiving the first dose of Osimertinib) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3-week prior) (refer to Section 6.9.1) are ineligible, and all patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4.

8. Has a history of (non-infectious) ILD/pneumonitis and/or radiation pneumonitis that required glucocorticoids, or has current ILD/pneumonitis and/or radiation pneumonitis, or where suspected ILD/pneumonitis and/or radiation pneumonitis cannot be ruled out by imaging at screening.
9. Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months prior to Cycle 1 Day 1, severe asthma, severe chronic obstructive pulmonary disorder, restrictive lung disease, significant pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and/or prior pneumonectomy (complete).
10. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.
11. Know human immunodeficiency virus (HIV) infection. Subjects should be tested for HIV prior to enrollment if required by local regulations or by the IRB/ EC.
12. Subjects have active viral (any etiology) hepatitis are excluded.
13. Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by serum pregnancy tests performed within 7 days prior to Cycle 1 Day 1.
14. Has clinically active central nervous system (CNS) metastases, defined as untreated, or symptomatic, or requiring therapy with glucocorticoids or anticonvulsants to control associated symptoms. However, subjects with asymptomatic CNS metastases who are radiologically and neurologically stable for at least 4 weeks following CNS-directed radiotherapy or surgery, and who are on stable or decreasing doses of glucocorticoids equivalent to ≤10 mg/day prednisone are eligible for study entry.
15. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE version 5.0, grade ≤ 1 or baseline.
16. Has multiple primary malignancies within 5 years before enrollment, except adequately resected non-melanoma skin cancer (e.g., resected basal or squamous cell skin cancer), curatively treated in-situ disease (e.g., carcinoma in situ of the cervix or breast), other solid tumors curatively treated (e.g., < T1 urothelial carcinoma), or contralateral breast cancer.
17. Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation or evaluation of the clinical study in the opinion of the investigator.
18. Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
19. Patients with other reasons that, in the opinion of the Investigator, make them unsuitable to participate in this study.
20. For Combo B of Phase 1 and Cohort 2g, 2k, 2m of Phase 2a, patients with refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of Osimertinib or capecitabine are ineligible.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

25

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DB-1310 Dose Level 1; Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W	Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Level 2; Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 2 on Day 1 of each cycle Q3W	Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Level 3; Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 3 on Day 1 of each cycle Q3W	Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Level 4; Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 4 on Day 1 of each cycle Q3W	Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Level 5; Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 5 on Day 1 of each cycle Q3W	Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Expansion 1; Enrolled Subjects with advanced/unresectable, or metastatic adenocarcinoma NSCLC with EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W	Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Expansion 2; Enrolled Subjects with advanced/unresectable, or metastatic NSCLC without EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W	Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Expansion 3; Enrolled Subjects with advanced/unresectable, or metastatic CRPC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W	Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Expansion 4; Enrolled Subjects with advanced/unresectable, or metastatic HNSCC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W	Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Expansion 6; Enrolled Subject with other advanced/unresectable, or metastatic solid tumors who have progressed on or after standard systemic treatment, or for which no standard systemic treatment is available will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W	Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Expansion 5; Enrolled Subjects with advanced/unresectable, or metastatic BC with HER2-positive (IHC3+, or IHC2+ and ISH+) who have progressed on or after HER2 targeted systemic treatments will receive a single-dose of DB-1310 on a selected dose level Day 1 of each cycle Q3W in combination with trastuzumab deruxtecan.	Drug: DB-1310; Administered I.V.; Drug: Trastuzumab; Administered I.V.
Experimental: DB-1310 Dose Expansion 7; Enrolled subjects with advanced/unresectable, or metastatic non-squamous NSCLC with EGFR exon 19 deletion or L858R mutation who haven't received any treatment in locally advanced, or metastatic disease will receive a single-dose of DB-1310 on a selected dose level Day 1 of each cycle Q3W in combination with Osimertinib.	Drug: Osimertinib; Oral; Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Expansion 8; Enrolled subjects with NSCLC with EGFR who will receive DB-1310 on a selected dose level in combination with Osimertinib	Drug: Osimertinib; Oral; Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Expansion 9; Enrolled subjects with NSCLC with KRAS mutation who will receive DB-1310 on a selected dose level (RP2D)	Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Expansion 10; Enrolled subjects with ESCC who will receive DB-1310 on a selected dose level (RP2D)	Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Expansion 11; Enrolled subjects with BTC who will receive DB-1310 on a selected dose level (RP2D)	Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Level 8; Enrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab	Drug: DB-1310; Administered I.V.; Drug: Trastuzumab; Administered I.V.
Experimental: DB-1310 Dose Level 11; Enrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib	Drug: Osimertinib; Oral; Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Level 6; Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W	Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Level 7; Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W	Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Level 9; Enrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab	Drug: DB-1310; Administered I.V.; Drug: Trastuzumab; Administered I.V.
Experimental: DB-1310 Dose Level 10; Enrolled subjects with HER2 positive BC who will receive DB-1310 on a selected dose level in combination with Trastuzumab	Drug: DB-1310; Administered I.V.; Drug: Trastuzumab; Administered I.V.
Experimental: DB-1310 Dose Level 12; Enrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib	Drug: Osimertinib; Oral; Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Level 13; Enrolled subjects with NSCLC subjects with EGFR Ex19del or L858R, G719X, S768I, L861Q alone or in combination with other EGFRm who will receive DB-1310 on a selected dose level in combination with Osimertinib	Drug: Osimertinib; Oral; Drug: DB-1310; Administered I.V.
Experimental: DB-1310 Dose Expansion 12; Enrolled subjects with HR+/HER2- BC who will receive DB-1310 on a selected dose level in monotherapy or combination with capecitabine	Drug: capecitabine; Oral; Drug: DB-1310; Administered I.V.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.	Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0	Up to follow-up period, approximately 1 year post-treatment
Phase 2a: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.	Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0	Up to follow-up period, approximately 1 year post-treatment
Phase 2a: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.	The percentage of subjects who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks	Up to follow-up period, approximately 1 year post-treatment
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by 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
Maximum Tolerated Dose (MTD) of DB-1310	MTD on the data collected during Part 1	12 months
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1310	RP2D of DB-1310 based on the data collected during Part 1	12 months
Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.	Percentage of participants with TEAE in Part 1 graded according to NCI CTCAE v5.0	Up to follow-up period, approximately 1 year post-treatment
Phase 2a: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.	Percentage of participants with TEAE in Part 2 graded according to NCI CTCAE v5.0	Up to follow-up period, approximately 1 year post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: ORR will be determined from tumor assessments by investigator per RECIST 1.1	Phase 1: ORR will be determined from tumor assessments by investigator per RECIST 1.1	with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: disease-control rate (DCR)	Phase 1 & Phase 2a: disease-control rate (DCR)	with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: progression free survival (PFS) will be determined from tumor assessments by investigator per RECIST 1.1	Phase 1 & Phase 2a: progression free survival (PFS) will be determined from tumor assessments by investigator per RECIST 1.1	with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: overall survival (OS)	Phase 1 & Phase 2a: overall survival (OS)	with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: duration of response (DoR) will be determined from tumor assessments by investigator per RECIST 1.1	Phase 1 & Phase 2a: duration of response (DoR) will be determined from tumor assessments by investigator (by BICR in cohort 3 in Phase 2a) per RECIST 1.1	with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-AUC	Area under the concentration-time curve from time 0 to infinity of DB-1310, total antibody and payload	within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-Cmax	Maximum observed plasma concentration (Cmax) of DB-1310, total antibody and payload	within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-Tmax	Time to Cmax of DB-1310, total antibody and payload	within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-T1/2	Phase 1 & Phase 2a: Pharmacokinetic-T1/2 of DB-1310, total antibody and payload	within 8 cycles (each cycle is 21 days)

Collaborators and Investigators

• Sponsor: DualityBio Inc.
• Investigators: Study Director: Lily Hu, DualityBio Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; NSCLC; non-small cell lung cancer; HNSCC; ESCC; head and neck squamous cell carcinoma; CRPC; HER3; castration-resistant prostate cancer; BC; BTC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Skin Diseases; Breast Diseases; Carcinoma; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Squamous Cell; Skin and Connective Tissue Diseases; Squamous Cell Carcinoma of Head and Neck; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Proteins; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Uracil; Pyrimidinones; Deoxyribonucleosides; Fluorouracil; Trastuzumab; Capecitabine; osimertinib
• Other Study ID Numbers: DB-1310-O-1001; CTR20231736 (Other Identifier: CENTER FOR DRUG EVALUATION, NMPA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No