Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo
About this trial
This is a single group study 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). * 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.
Eligibility criteria
Qualifiers
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 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by Investigator. Measurable lesions should not be from a previously irradiated site. If the lesion at a previously irradiated site is the only selectable target lesion, a radiological assessment showing significant progression of the irradiated lesion should be provided by the Investigator
Has adequate cardiac, hematopoietic, renal and hepatic functions
Has an adequate treatment washout period prior to start of study treatment
Disqualifiers
Has prior treatment with B7-H3 targeted agent, including I-DXd.
Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., trastuzumab deruxtecan) due to treatment-related toxicities.
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
Trial design
Treatments tested in this trial
- Ifinatamab deruxtecan (I-DXd)
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Daiichi Sankyo
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov