Study of MHB088C for Patients With Advanced Solid Malignant Tumors

July 28, 2025 updated by: Qilu Pharmaceutical Co., Ltd.

A Phase I/II Study of MHB088C for Patients With Advanced Malignant Solid Tumors

This is a Phase I/II, multicenter, open-label clinical trial with dose escalation/dose expansion/efficacy expansion phases, designed to evaluate the safety/tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of MHB088C in participants with advanced solid tumors

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
515

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;
  • Age ≥ 18 years old when signing the informed consent form;
  • The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1;
  • The expected survival time is at least 3 months;
  • Eligible participants of childbearing potential must agree to take highly reliable contraceptive measures with their partners during the study and within at least 90 days after the last dose and agree not to retrieve, freeze or donate sperm or ova from screening to at least 3 months after the last dose of investigational drug; female participants of childbearing potential must have a negative results of blood pregnancy test before the first dose of investigational drug, and must be non-lactating.
  • Understand study requirements, willing and able to comply with study and follow-up procedures.

Neoplasm-related criteria

  • Phase Ia: Histologically or cytologically confirmed unresectable advanced or metastatic malignant solid tumors, that is progressed or intolerant with standard of care (SOC), or for which no SOC regimens are available.
  • Phase Ib: Histologically or cytologically confirmed unresectable advanced or metastatic malignant solid tumors, that is relapsed or progressed following systemic treatment or no SOC is available;
  • Phase II: Histologically or cytologically documented unresectable advanced or metastatic SCLC and previous progressed during or after platinum-contained chemotherapy and immune-checkpoint inhibitors (ICIs).

Exclusion Criteria:

  • Has more than 2 primary malignancies before signing of Informed Consent Form.
  • Has received anti-tumor treatment before the first dose of investigational product; Medication of traditional Chinese medicine before the first dose of investigational drug.
  • Medication of other unmarketed investigational drugs or therapies before the first dose of investigational drug.
  • Presence of unstable brain metastases and/or leptomeningeal carcinomatosis.
  • Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1;
  • Has underwent major organ surgery or significant trauma before the first dose of investigational drug or requiring elective surgery during the study.
  • Has vaccinated with attenuated live vaccines before the first dose of investigational drug.
  • Has mucosal or internal bleeding for non-traumatic reason before the first dose of investigational drug.
  • Has received treatment with systemic corticosteroids or other immunosuppressive agents before the first dose of investigational drug.
  • Has pulmonary disease that severely impact pulmonary function.
  • Has history of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonia, or suspected ILD/pneumonia that cannot be excluded by imaging examination at screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MHB088C administered

If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial.

Phase Ia:

Participants with advanced solid tumor.

Phase Ib:

Participants with advanced solid tumor

Phase II:

Participants with advanced SCLC
Drug: MHB088C for Injection
MHB088C for Injection, an antibody drug-conjugated molecule (ADC) MHB088C will be administered intravenously at a frequency of once every 2 weeks (Q2W) or every 3 week (Q3W).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse event (AE) and Serious adverse event (SAE) (Phase Ia)
Time Frame: After first administration of study drug until 30 days after last dose of study drug. Through phase Ia completion, an average of 1 year.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
After first administration of study drug until 30 days after last dose of study drug. Through phase Ia completion, an average of 1 year.
Dose limited toxicity (DLT) (Phase Ia)
Time Frame: Cycle 1 (28 days for subjects receiving a dosing frequency of every 2 weeks, or 21 days for subjects receiving a dosing frequency of every 3 weeks)
The DLTs of MHB088C will be determined.
Cycle 1 (28 days for subjects receiving a dosing frequency of every 2 weeks, or 21 days for subjects receiving a dosing frequency of every 3 weeks)
Maximum tolerated dose (MTD) (Phase Ia)
Time Frame: Cycle 1 (28 days for subjects receiving a dosing frequency of every 2 weeks, or 21 days for subjects receiving a dosing frequency of every 3 weeks).
The maximum tolerated dose (MTD) of MHB088C will be evaluated on the first cycle.
Cycle 1 (28 days for subjects receiving a dosing frequency of every 2 weeks, or 21 days for subjects receiving a dosing frequency of every 3 weeks).
Recommended phase II dose (RP2D) (Phase Ib)
Time Frame: Through phase Ib completion, an average of 1 year.
RP2D will be selected upon safety, PK and efficacy data.
Through phase Ib completion, an average of 1 year.
Objective response rate (ORR) (phase II)
Time Frame: Approximately 48 months.
The ORR is defined as the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR), based on RECIST Version 1.1
Approximately 48 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MHB088C-CP001CN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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