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)
Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
DAIICHI SANKYO Co.,Ltd.
1-2-58, Hiromachi, Shinagawa-ku, Tokyo
+81-3-6225-1111
dsclinicaltrial@daiichisankyo.co.jp
DAIICHI SANKYO Co.,Ltd.
1-2-58, Hiromachi, Shinagawa-ku, Tokyo
+81-3-6225-1111
dsclinicaltrial@daiichisankyo.co.jp
recruiting
Oct. 17, 2019
250
Interventional
multi center, open-label
treatment purpose
1-2
1. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
2. 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.
3. Has adequate cardiac, hematopoietic, renal and hepatic functions
4. Has an adequate treatment washout period prior to start of study treatment
5. 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.
1. Has prior treatment with B7-H3 targeted agent, including I-DXd.
2. 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.
3. 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.
4. Uncontrolled significant cardiovascular disease
5. 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
6. Has an uncontrolled infection requiring systemic therapy.
7. 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.
18age old over
No limit
Both
advanced solid malignant tumors
investigational material(s)
Generic name etc : Ifinatamab Deruxtecan (I-DXd)
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Dose Escalation Part : IV solution (Once every 3 weeks, initial dose 0.8 mg /kg), Dose Expansion Part : IV solution (Once every 3 weeks, recommended dose for expansion part)
safety
efficacy
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.
pharmacokinetics
other
1. To characterize the pharmacokinetic (PK) properties of I-DXd, total anti- B7-H3 antibody and MAAA-1181a.
2. To assess the incidence of anti-drug antibodies against I-DXd.
