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Advanced Solid CancerPhase 1/2NCT06985355

A Study of MHB046C Injection in Patients With Advanced Solid Tumors

A Phase 1/2 study testing MHB046C in people with Advanced Solid Cancer, run by Minghui Pharmaceutical (Hangzhou) Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a first-in-human, open-label, multicenter Phase I/II study of MHB046C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB046C monotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Cancer
What is being tested?
MHB046C
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
17 Jul 2025to May 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily agrees to participate in the study and signs the informed consent form.
  • Age ≥ 18 years, no restriction on gender.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Estimated life expectancy ≥ 3 months.
  • Able to understand and comply with the study protocol and follow-up procedures.
  • Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
  • At least one measurable lesion per RECIST v1.1 criteria.
  • Adequate organ function.

Who cannot join

  • History of ≥2 primary malignancies within 5 years prior to informed consent.
  • Received chemotherapy within 3 weeks, radiotherapy within 4 weeks (2 weeks for palliative bone radiotherapy), or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
  • Brain metastases (unless asymptomatic, no edema, stable ≥4 weeks without steroids), leptomeningeal disease, brainstem metastases, or spinal cord compression.
  • Severe lung disease affecting pulmonary function.
  • Active systemic infection requiring treatment within 7 days before dosing.
  • Serious cardiovascular or cerebrovascular diseases
Show all 13Show fewer
  • Uncontrolled third-space effusions not suitable for enrollment:
  • Uncontrolled diabetes, including ketoacidosis or hyperosmolar state within 6 months.
  • Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.
  • Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
  • Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
  • Known alcohol or drug dependence.
  • Pregnant or breastfeeding women, or individuals planning to conceive.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

VP of R&D contact

86 0571-86963293

jwshi@minghuipharma.com

China1 site, 1 recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

    Ethics Committee, +86 20 8382 7812, gdghospital_ec@gdph.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB046C Injection in Patients With Advanced Solid Tumors

This is a first-in-human, open-label, multicenter Phase I/II study of MHB046C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB046C monotherapy.

Read the detailed description

This first-in-human clinical trial of MHB046C comprises two parts: a dose escalation phase and an indication expansion phase. The dose escalation phase is an open-label, multicenter study including dose escalation and PK expansion cohorts. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MHB046C in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD). In this phase, additional patients may be enrolled in the PK expansion part at dose levels that have completed DLT (dose-limiting toxicity) evaluation.

Based on the safety, PK, and preliminary efficacy data from the completed DLT-evaluated dose levels, the sponsor will initiate the indication expansion phase. This phase is an open-label, multicenter, multi-cohort study designed to further evaluate the safety and efficacy of MHB046C monotherapy in patients with specific types of advanced solid tumors.

Being tested
MHB046C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MHB046CDrug

    IV administration of MHB046C Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Study groups in NCT06985355
Study groupRoleWhat they receive
MHB046C (Phase I: Dose escalation)ExperimentalThere are six escalating dose cohorts.
Receives: Drug: MHB046C
MHB046C (Phase II: Dose expansion)ExperimentalThe recommended dose from the dose-escalation stage and other potential doses will be further explored.
Receives: Drug: MHB046C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. I (Dose-Escalation Stage): Maximum tolerated dose (MTD) for MHB046C

    To determine the MTD for further evaluation of IV administration of MHB046C in subjects with advanced solid tumors.

    Measured: Up to day 21 from the first dose

  2. II (Dose-Expansion Stage): ORR determined by investigators according to RECIST v1.1

    To determine the recommended Phase II dose (RP2D) of MHB046C for the treatment of selected patients with advanced solid tumors based on the safety and efficacy results from all enrolled subjects.

    Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years

Secondary outcomes (9)

  1. Incidence and severity of adverse events (AEs)

    AE assessed by investigator exclusively related to subject's underlying disease or medical condition [graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0].

    Measured: Baseline up to 5 years

  2. Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points

    The PK parameters at different time points include:Area Under the Concentration-Time Curve (AUC)

    Measured: From pre-dose to 22 days after the first dose

  3. Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points

    The PK parameters at different time points include:Maximum Plasma Concentration (Cmax)

    Measured: From pre-dose to 22 days after the first dose

  4. Immunogenicity

    Proportion of subjects who develop anti-MHB046C antibodies (ADA).

    Measured: From pre-dose to 30 days post end of treatment.

  5. ORR determined by investigators according to RECIST v1.1

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of CR and PR (Confirmed CR/PR assessment require at least 1 repeat).

    Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years

  6. Duration of response (DOR) determined by investigators according to RECIST v1.1

    DoR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].

    Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years

  7. Disease control rate (DCR) determined by investigators according to RECIST v1.1

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) [Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose].

    Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years

  8. Progression-free survival (PFS) determined by investigators according to RECIST v1.1

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). PFS was defined as the time from random assignment (dose expansion stage) or first dose (dose escalation stage) to PD or death from any cause.

    Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years

  9. Overall survival (OS)

    OS was defined as the time from random assignment or first dose to death from any cause.

    Measured: Baseline up until death up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2025
  2. Study start17 Jul 2025
  3. Primary completionMay 2029 (estimated)
  4. Study completionMay 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06985355
Sponsor's protocol ID
MHB046C-A-101
Status last verified
Oct 2026
First submitted
7 May 2025
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MHB046C in people with Advanced Solid Cancer, run by Minghui Pharmaceutical (Hangzhou) Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact VP of R&D (86 0571-86963293, jwshi@minghuipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

I (Dose-Escalation Stage): Maximum tolerated dose (MTD) for MHB046C (time frame: Up to day 21 from the first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06985355.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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