Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
NBE-Therapeutics AG
With
Cmed Clinical Services
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent
Age ≥18 years
Phase 1, DEC and SEC: patients with histologically or cytologically confirmed advanced solid tumor (carcinoma or sarcoma), who have progressive disease, have undergone systemic therapy for advanced disease, and for whom no standard therapy is available
Phase 2, EC1: patients with histologically or cytologically confirmed advanced triple-negative breast cancer, who have progressive disease, and have undergone no more than three prior lines of systemic therapy for advanced disease
Phase 2, EC2: patients with histologically or cytologically confirmed advanced solid tumor (carcinoma or sarcoma) other than TNBC, who have progressive disease, and have undergone no more than three prior lines of systemic therapy for advanced disease
Availability of pretreatment tumor tissue
Phase 1, DEC and SEC: at least one measurable or non-measurable lesion as per RECIST v1.1
Phase 2, EC1 and EC2: at least one measurable lesion as per RECIST v1.1
Phase 1, DEC and SEC: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Phase 2, EC1 and EC2: ECOG performance status of 0 or 1
Adequate function of bone marrow, liver, kidneys, heart; adequate coagulation profile
Both male and female patients must agree to use effective contraceptive methods
Women of child-bearing potential (WCBP) must have a negative serum pregnancy test
Patients must be willing and able to sign the informed consent form, and to adhere to the study visit schedule and other protocol requirements
You may not be if
Prior treatment with any agent targeting ROR1
Presence of active central nervous system (CNS) metastasis
Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \> 1 (or Grade \> 2 for neurotoxicity)
Systemic anti-neoplastic therapy within five half-lives or four weeks (six weeks for nitrosourea and mitomycin-C), whichever is shorter, prior to first dose of the study drug
Wide-field radiotherapy within four weeks, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within two weeks prior to first dose of the study drug, or no recovery from side effects of such intervention
Major surgery within four weeks prior to first dose of the study drug, or no recovery from side effects of such intervention
Prior allogeneic bone marrow transplantation
Significant cardiac disease
History of thromboembolic or cerebrovascular events within six months prior to first dose of the study drug
Acute and/or clinically significant bacterial, fungal or viral infection
Concomitant use of systemic steroids at dose of \>10 mg of prednisone or its equivalent per day
Concurrent participation in another investigational clinical trial
Pregnant or breast-feeding females
Other conditions that prevent the patient from giving informed consent or participating in the trial, or that may increase the risk associated with the study participation, or that may interfere with the interpretation of the study results
Prior history of malignancy other than inclusion diagnosis within three years prior to first dose of the study drug
Prior treatment with cumulative lifetime dose of anthracycline
