Advanced Solid Tumor Clinical Trial
Official title:
Phase I/II, Two-Part, Multicenter First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Subjects With Advanced Solid Malignant Tumors (IDeate-Pantumor01)
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). - 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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | March 1, 2027 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 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 - 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: - 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 - 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. |
Country | Name | City | State |
---|---|---|---|
Japan | Aichi Cancer Center Hospital | Aichi | |
Japan | National Cancer Center Hospital East | Chiba | |
Japan | Osaka University Hospital | Osaka | |
Japan | Saitama Cancer Center | Saitama | |
Japan | Shizuoka Cancer Center Hospital and Research Institute | Shizuoka | |
Japan | Cancer Institute Hospital of JFCR | Tokyo | |
Japan | National Cancer Center Hospital | Tokyo | |
Japan | Showa University Hospital | Tokyo | |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | The Ohio State University | Columbus | Ohio |
United States | Sarah Cannon Research Institute at HealthONE | Denver | Colorado |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey |
United States | MDACC (MD Anderson Cancer Center) | Houston | Texas |
United States | Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California |
United States | SCRI Oncology Partners | Nashville | Tennessee |
United States | Tennessee Oncology | Nashville | Tennessee |
United States | Columbia University Medical Center | New York | New York |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Florida Cancer Specialists | Orlando | Florida |
United States | Sidney Kimmel Cancer Center - Thomas Jefferson | Philadelphia | Pennsylvania |
United States | Washington University | Saint Louis | Missouri |
United States | Florida Cancer Specialists | Sarasota | Florida |
Lead Sponsor | Collaborator |
---|---|
Daiichi Sankyo | Merck Sharp & Dohme LLC |
United States, Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the incidence of dose-limiting toxicities (DLTs) | Day 1 to Day 21 in Cycle 1 in the dose escalation part | ||
Primary | Evaluate the incidence of adverse events (AEs) | Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) | ||
Primary | Investigate the antitumor activity of ifinatamab deruxtecan (I-DXd) | Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) | ||
Secondary | Characterize the PK parameter AUClast | Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) | ||
Secondary | Characterize the PK parameter AUCtau | Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) | ||
Secondary | Characterize the PK parameter Cmax | Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) | ||
Secondary | Characterize the PK parameter Tmax | Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) | ||
Secondary | Characterize the PK parameter Ctrough | Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) | ||
Secondary | Assess the incidence of anti-drug antibodies (ADAs) | Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) |
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