Health TrialsbyHealthPanel

A Study of NBL-020 Injection in Subjects With Advanced Malignant Tumors.

ConditionAdvanced Malignant Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovaRock Biotherapeutics, Ltd

About this trial

This study aims to evaluate the safety and tolerability of NBL-020 injection in subjects with advanced malignant tumors, and determine the dose limiting toxicity (DLT), maximum tolerable dose (MTD) (if any), recommended phase II dose (RP2D), and dosing regimen of NBL-020.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Those who are 18 years old or older (based on the date of signing the informed consent form) and voluntarily sign the informed consent form;

For malignant tumors confirmed by histology or cytology, only solid tumor subjects were included in dose escalation study. In addition to solid tumors, additional skin T-cell lymphoma subjects could be considered in dose expansion study;

Must be willing to provide tumor tissue samples that can meet the requirements of biomarker testing (fresh biopsy tissue is preferred; if fresh tissue cannot be provided, tumor tissue samples within 2 years can be provided), and tumor samples will be tested by the central laboratory. If tumor tissue does not meet the testing requirements, additional biopsy may be required;

If the standard treatment fails or toxicity is intolerable, or there is no standard treatment, the enrolled subjects must fully recover from previous treatment, with an AE level of 0-1 (except for alopecia, pigmentation, or other toxicity that the researcher believes is not a safety risk to the subjects);

Disqualifiers

Subjects with a history of severe allergies to monoclonal antibodies;

Active pia mater lesions or uncontrolled brain metastases exist. Subjects with suspected or confirmed brain metastasis can be enrolled as long as they are asymptomatic and do not require treatment (such as radiotherapy, surgery, or corticosteroid therapy) to control the symptoms of brain metastasis. For subjects with brain metastasis requiring treatment, their symptoms remain stable (without hormone maintenance treatment, without symptoms of brain metastasis) for 2 weeks after treatment, and they can be enrolled.

Subjects with active autoimmune diseases or a history of autoimmune diseases, but with the following diseases are allowed to be included in the study: well controlled type I diabetes, well controlled hypothyroidism only requiring hormone replacement treatment, skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia), or subjects who are expected to have no relapse under the condition of no external trigger factors;

Having a history of primary immunodeficiency, a history of allogeneic organ transplantation, or a history of allogeneic hematopoietic stem cell transplantation;

Trial design

Design model

Single group

Treatments tested in this trial

  • NBL-020 for Injection

    Drug

    NBL-020 for Injection, Q3W, i.v.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: NBL-020Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The occurrence of all adverse events (AEs) and severe adverse events (SAEs).

adverse events (AEs) and severe adverse events (SAEs)

Time frame
From the first administration to 30 days after the end of the last administration, up to approximately 2 years

Secondary outcomes

1

Cmax

Observed maximum concentration

Time frame
14 days
2

AUC0-t

AUC0-t

Time frame
14 days
3

AUC0-inf

AUC0-inf

Time frame
14 days
4

Tmax

Time to maximum concentration

Time frame
14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NovaRock Biotherapeutics, Ltd

Lead sponsor

Source ClinicalTrials.gov
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