Trials Sponsors Conditions Drugs Pricing

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

Incidence of participants with adverse events (AE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Until 30 days after last dose of MHB039A
Number of participants with dose-limiting toxicity (DLT)
DLTs will be assessed during the dose-escalation phase and are defined as toxicities related to MHB039A which meet pre-defined severity criteria and occurs within the first cycle of treatment.
At the end of Cycle 1 (each cycle is 21 days for every three weeks cohort and 28 days for every two weeks cohort)

Secondary Outcomes (4)

Maximum Plasma Concentration (Cmax) of MHB039A
Until 30 days after last dose of MHB039A
The area under the plasma concentration-time curve (AUC) of MHB039A
Until 30 days after last dose of MHB039A
To detectable anti-drug antibodies with treated subjects
Until 30 days after last dose of MHB039A
Objective response rate (ORR)
Until 30 days after last dose of MHB039A

Study Arms (1)

MHB039A

EXPERIMENTAL

MHB039A IV every 2 weeks or every 3 weeks (including 5mg/kg、10mg/kg、20mg/kg and 30mg/kg)

Drug: MHB039A

Interventions

MHB039ADrug

a bispecific antibody

MHB039A

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.
Written and signed informed consent

Sponsors & Collaborators

Minghui Pharmaceutical (Hangzhou) Ltd
Industrylead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Study Officials

Shun Lu, MD
Shanghai Chest Hospital
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 18, 2024

First Posted

April 3, 2024

Study Start

April 16, 2024

Actual (reported)

Primary Completion

April 1, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

A Study of MHB039A for Advanced Solid Tumor

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

MHB039A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

MHB039A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations