Study of DS-7300a in Participants With Advanced Solid Malignant Tumors
About the study
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 ifinatamab deruxtecan (I-DXd; DS-7300a).
Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of I-DXd 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:
they withdraw
their disease gets worse
they experience unacceptable side effects.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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. 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.
- Has adequate cardiac, hematopoietic, renal and hepatic functions
- Has an adequate treatment washout period prior to start of study treatment
- 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
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 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.
- Uncontrolled significant cardiovascular disease
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement, prior pneumonectomy, or requirement for supplemental oxygen
- Has an uncontrolled infection requiring systemic therapy.
- 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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Advanced Solid Tumor,Malignant Solid Tumor
Age (in years)
18+
Phase
Phase 1/Phase 2
Participants needed
195
Est. Completion Date
Mar 31, 2027
Treatment type
Interventional
Sponsor
Daiichi Sankyo, Inc.
ClinicalTrials.gov identifier
NCT04145622
Study number
DS7300-A-J101
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