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 MHB036C
Number of participants with dose-limiting toxicity (DLT)
DLTs will be assessed during the dose-escalation phase and are defined as toxicities related to MHB036C 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)

Secondary Outcomes (4)

Maximum Plasma Concentration (Cmax)
Until 30 days after last dose of MHB036C
The area under the plasma concentration-time curve (AUC)
Until 30 days after last dose of MHB036C
To detectable anti-drug antibodies with treated subjects
Until 30 days after last dose of MHB036C
Objective response rate (ORR)
Until 30 days after last dose of MHB036C

Study Arms (1)

MHB036C

EXPERIMENTAL

MHB036C IV every 3 weeks

Drug: MHB036C

Interventions

MHB036CDrug

An antibody-drug conjugate therapy

MHB036C

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:

Participants voluntarily agree to participate in the study and sign the Informed Consent Form (ICF).
Participants aged 18 years or older (inclusive), without gender limitation.

Sponsors & Collaborators

Minghui Pharmaceutical (Hangzhou) Ltd
Industrylead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, 200030, China

Study Officials

Shun Lu
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

April 15, 2024

First Posted

April 18, 2024

Study Start

May 26, 2023

Actual (reported)

Primary Completion

April 2027

Estimated

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

A Study of MHB036C for Advanced Solid Tumor

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

MHB036C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

MHB036C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations