KN046 in Subjects With Advanced Solid Tumors and Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-18

Study Completion Date

2023-02-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a phase Ia/Ib, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN046 in subjects with advanced solid tumors and lymphoma .

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Antitumor Activity of KN046 in Subjects With Advanced Solid Tumors

NCT03529526

Advanced Solid Tumors

UNKNOWN PHASE1

Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of CM369 in Advanced Solid Tumors & Hematologic Malignancies

NCT05690581

Advanced Solid Tumors and Hematologic Malignancies

RECRUITING PHASE1

A Phase Ia Clinical Study of QLF31907 Injection in Patients With Advanced Malignant Tumors

NCT05150405

Solid Tumor Lymphoma, Non-Hodgkin

RECRUITING PHASE1

Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's Lymphoma

NCT01356173

Non-Hodgkin's Lymphoma, Solid Tumor

COMPLETED PHASE1

A Study of KM501 in Patients With Solid Tumors

NCT05804864

Advanced Solid Tumors

NOT_YET_RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumors Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

KN046

Group Type EXPERIMENTAL

KN046

Intervention Type DRUG

Phase Ia：Intravenous (IV) infusions, 1,3 and 5 milligrams per kilogram (mg/kg) every 2 weeks.

Phase Ib：Intravenous (IV) infusions, 1 ,3 or 3, 5 milligrams per kilogram (mg/kg) every 2 weeks, the dose of phase Ib based on the result of phase Ia.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

KN046

Phase Ia：Intravenous (IV) infusions, 1,3 and 5 milligrams per kilogram (mg/kg) every 2 weeks.

Phase Ib：Intravenous (IV) infusions, 1 ,3 or 3, 5 milligrams per kilogram (mg/kg) every 2 weeks, the dose of phase Ib based on the result of phase Ia.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Signed informed consent; willing and able to complete all required procedures of study.
2. With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
3. Subjects must have at least one measurable lesion in advanced solid tumors, at least one measurable or assessable lesion in NK/T cell lymphoma.
4. ECOG performance status of 0 or 1.
5. Subject must have adequate organ function.
6. Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
7. Ability to comply with treatment, procedures and PK sample collection and the required study follow-up procedures.

Exclusion Criteria

1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
2. Is currently participating or has participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment.
3. Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
4. Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
5. Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
6. Active HBV or HCV infection.
7. Known HIV infection or known history of acquired immune deficient syndrome (AIDS).
8. Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
9. Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No