NBE-002 in Patients With Advanced Solid Tumors

STATUS

Recruiting
participants needed

100
sponsor

NBE-Therapeutics AG

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Updated on 19 February 2024

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cancer

breast cancer

serum pregnancy test

measurable disease

solid tumour

solid tumor

sarcoma

progressive disease

carcinoma

triple-negative breast cancer

anthracyclines

systemic therapy

advanced solid tumor

solid neoplasm

advanced malignant solid tumor

anthracycline

blood coagulation tests

Summary

This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of NBE-002, a novel anti-ROR1 antibody-drug conjugate, in patients with advanced solid tumors.

Details

Condition	Breast Cancer, Breast Cancer, Breast Cancer - HER2 Positive, Advanced Solid Tumor, Advanced Cancer, Chronic Shoulder Pain
Age	18years - 100years
Treatment	NBE-002
Clinical Study Identifier	NCT04441099
Sponsor	NBE-Therapeutics AG
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
Exclusion Criteria
	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

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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NBE-002 in Patients With Advanced Solid Tumors