History of Changes for Study: NCT04145622

Study of DS-7300a in Participants With Advanced Solid Malignant Tumors

Latest version (submitted May 15, 2024) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	October 28, 2019	None (earliest Version on record)
2	December 3, 2019	Contacts/Locations and Study Status
3	January 30, 2020	Contacts/Locations and Study Status
4	March 3, 2020	Study Status and Contacts/Locations
5	April 3, 2020	Contacts/Locations and Study Status
6	April 22, 2020	Contacts/Locations and Study Status
7	May 7, 2020	Study Status
8	June 1, 2020	Study Status
9	June 15, 2020	Contacts/Locations and Study Status
10	July 1, 2020	Study Status
11	August 3, 2020	Study Status
12	September 1, 2020	Study Status
13	October 15, 2020	Study Status and Contacts/Locations
14	November 10, 2020	Study Status
15	December 11, 2020	Study Status
16	January 14, 2021	Study Status and Contacts/Locations
17	February 9, 2021	Study Status
18	March 5, 2021	Study Status and Contacts/Locations
19	April 12, 2021	Study Status and Contacts/Locations
20	May 19, 2021	Study Status and Contacts/Locations
21	June 16, 2021	Contacts/Locations and Study Status
22	July 19, 2021	Contacts/Locations and Study Status
23	August 20, 2021	Study Status and Contacts/Locations
24	September 1, 2021	Study Status, Eligibility, Study Design and Study Description
25	December 13, 2021	Contacts/Locations and Study Status
26	May 18, 2022	Study Status, IPDSharing and Contacts/Locations
27	July 14, 2022	Study Status, Contacts/Locations and Study Design
28	July 26, 2022	Contacts/Locations and Study Status
29	September 6, 2022	Contacts/Locations, Study Status and Study Design
30	October 24, 2022	Contacts/Locations and Study Status
31	January 5, 2023	Study Status
32	February 7, 2023	Contacts/Locations and Study Status
33	April 17, 2023	Study Status, IPDSharing, Arms and Interventions, Eligibility, Outcome Measures, Conditions and Study Description
34	May 22, 2023	Study Status
35	June 28, 2023	Study Status
36	September 5, 2023	Study Status
37	September 18, 2023	Study Status
38	January 4, 2024	Study Status and Contacts/Locations
39	January 11, 2024	Arms and Interventions, Study Design, Conditions, Study Description, Study Status and Study Identification
40	May 13, 2024	Sponsor/Collaborators, Study Status, Study Identification, Eligibility and Arms and Interventions
41	May 15, 2024	Contacts/Locations and Study Status

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Study NCT04145622
Submitted Date: October 28, 2019 (v1)

Study Identification


Unique Protocol ID:	DS7300-A-J101
Brief Title:	Study of DS-7300a in Participants With Advanced Solid Malignant Tumors
Official Title:	Phase I/II, Two-Part, Multicenter First-in-Human Study of DS-7300a in Subjects With Advanced Solid Malignant Tumors
Secondary IDs:	194992 [JapicCTI]

Study Status


Record Verification:	October 2019
Overall Status:	Recruiting
Study Start:	October 17, 2019
Primary Completion:	January 31, 2023 [Anticipated]
Study Completion:	January 31, 2023 [Anticipated]

First Submitted:	October 17, 2019
First Submitted that Met QC Criteria:	October 28, 2019
First Posted:	October 30, 2019 [Actual]

Last Update Submitted that Met QC Criteria:	October 28, 2019
Last Update Posted:	October 30, 2019 [Actual]

Study Description

Brief Summary:

This study is in one single group of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts.

The primary purpose of the parts are:

Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of DS-7300a.
Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of DS-7300a.

This study is expected to last approximately 3.5 years from the time the first participant is enrolled to the time the last participant is off the study.

The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless:

they withdraw
their disease gets worse
they experience unacceptable side effects.

Detailed Description:

Conditions


Conditions:	Advanced Solid Tumor Malignant Solid Tumor
Keywords:	Advanced Solid Tumor Malignant Tumor DS-7300a

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1/Phase 2
Interventional Study Model:	Sequential Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	160 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Dose escalation All participants enrolled in the dose escalation part	Drug: DS-7300a A total anti-B7H3 antibody and MAAA-1181a
Experimental: Dose expansion All participants enrolled in the dose expansion part	Drug: DS-7300a A total anti-B7H3 antibody and MAAA-1181a

Outcome Measures


Primary Outcome Measures:
1.	Evaluate the incidence of dose-limiting toxicities (DLTs) [ Time Frame: Day 1 to Day 21 in Cycle 1 in the dose escalation part ]
2.	Evaluate the incidence of adverse events (AEs) [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
3.	Investigate the antitumor activity of DS-7300a [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
Secondary Outcome Measures:
1.	Characterize the PK parameter AUClast [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
2.	Characterize the PK parameter AUCtau [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
3.	Characterize the PK parameter Cmax [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
4.	Characterize the PK parameter Tmax [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
5.	Characterize the PK parameter Ctrough [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]
6.	Assess the incidence of anti-drug antibodies (ADAs) [ Time Frame: Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Has adequate cardiac, hematopoietic, renal and hepatic functions Has an adequate treatment washout period prior to start of study treatment Additional Inclusion Criteria for Part 1 (Dose Escalation) Has a pathologically documented advanced/unresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and adenocarcinoma non-small cell lung cancer (NSCLC), bladder cancer, sarcoma, endometrial cancer, melanoma, prostate cancer, breast cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. Additional Inclusion Criteria for Part 2 (Dose Expansion) Has a pathologically documented advanced/unresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous-NSCLC that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. Additional or alternative indications may be added to expansion cohorts based on preliminary signals of activity in dose escalation via a protocol amendment. Exclusion Criteria: Has prior treatment with B7-H3 targeted agent. Has prior treatment with an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan). Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years. Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association classes II-IV), unstable angina or serious cardiac arrhythmia. Has an uncontrolled infection requiring systemic therapy. Has clinically significant pulmonary compromise or requirement for supplemental oxygen. Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation of the subject or evaluation of the clinical study in the opinion of the Investigator.

Contacts/Locations


Central Contact Person:	Daiichi Sankyo Contact for Clinical Trial Information Telephone: +81-3-6225-1111(M-F 9-5 JST) Email: dsclinicaltrial@daiichisankyo.co.jp
Study Officials:	Global Clinical Leader Study Director Daiichi Sankyo
Locations:	United States, Tennessee
	Tennessee Oncology [Recruiting] Nashville, Tennessee, United States, 37205 Contact:Contact: Principal Investigator
	Japan
	National Cancer Center Hospital East [Recruiting] Chiba, Japan, 277-8577 Contact:Contact: See Central Contact
	National Cancer Center Hospital [Recruiting] Tokyo, Japan, 104-0045 Contact:Contact: See Central Contact

IPDSharing


Plan to Share IPD:	Yes De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
	Supporting Information: Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR)
	Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
	Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
	URL: https://vivli.org/ourmember/daiichi-sankyo/

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