Study of DS-7300a in Participants With Advanced Solid Malignant Tumors
Study Details
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:
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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.
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Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of DS-7300a when administered as a single agent.
This study is expected to last approximately 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:
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they withdraw
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their disease gets worse
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they experience unacceptable side effects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
- Evaluate the incidence of dose-limiting toxicities (DLTs) [Day 1 to Day 21 in Cycle 1 in the dose escalation part]
- Evaluate the incidence of adverse events (AEs) [Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)]
- Investigate the antitumor activity of DS-7300a [Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)]
Secondary Outcome Measures
- Characterize the PK parameter AUClast [Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)]
- Characterize the PK parameter AUCtau [Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)]
- Characterize the PK parameter Cmax [Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)]
- Characterize the PK parameter Tmax [Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)]
- Characterize the PK parameter Ctrough [Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)]
- Assess the incidence of anti-drug antibodies (ADAs) [Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
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Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Castrate-resistant prostate cancer (CRPC) participants with bone only disease may be eligible on a case-by- case basis after discussion with the Medical Monitor.
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Has adequate cardiac, hematopoietic, renal and hepatic functions
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Has an adequate treatment washout period prior to start of study treatment
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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), small cell lung cancer (SCLC), bladder cancer, sarcoma, endometrial cancer, melanoma, adenocarcinoma CRPC (primary neuroendocrine or histologically confirmed neuroendocrine differentiated prostate cancer is not allowed), breast cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Exclusion Criteria:
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Has prior treatment with B7-H3 targeted agent.
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Has prior treatment with an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan).
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Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial GI tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.
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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.
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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 pleural effusion.
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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.
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Prior complete pneumonectomy.
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Has an uncontrolled infection requiring systemic therapy.
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Has clinically significant pulmonary compromise or requirement for supplemental oxygen.
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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 and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California | United States | 90048 |
| 2 | Sarah Cannon Research Institute at HealthONE | Denver | Colorado | United States | 80218 |
| 3 | Florida Cancer Specialists | Orlando | Florida | United States | 32804 |
| 4 | Florida Cancer Specialists | Sarasota | Florida | United States | 34232 |
| 5 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 6 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 7 | Washington University | Saint Louis | Missouri | United States | 63110 |
| 8 | John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 9 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 10 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
| 11 | The Ohio State University | Columbus | Ohio | United States | 43210 |
| 12 | Sidney Kimmel Cancer Center - Thomas Jefferson | Philadelphia | Pennsylvania | United States | 19107 |
| 13 | Tennessee Oncology | Nashville | Tennessee | United States | 37203 |
| 14 | MDACC (MD Anderson Cancer Center) | Houston | Texas | United States | 77030 |
| 15 | Aichi Cancer Center Hospital | Aichi | Japan | 464-8681 | |
| 16 | National Cancer Center Hospital East | Chiba | Japan | 277-8577 | |
| 17 | Osaka University Hospital | Osaka | Japan | 565-0871 | |
| 18 | Saitama Cancer Center | Saitama | Japan | 362-0806 | |
| 19 | Shizuoka Cancer Center Hospital and Research Institute | Shizuoka | Japan | 411-8777 | |
| 20 | National Cancer Center Hospital | Tokyo | Japan | 104-0045 | |
| 21 | Cancer Institute Hospital of JFCR | Tokyo | Japan | 135-8550 | |
| 22 | Showa University Hospital | Tokyo | Japan | 142-8666 |
Sponsors and Collaborators
- Daiichi Sankyo Co., Ltd.
Investigators
- Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DS7300-A-J101
- 194992