A Study of MHB046C Injection in Patients With Advanced Solid Tumors

NCT06985355 | Recruiting Phase 1

• 1 other identifier: MHB046C-A-101
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to day 21 from the first dose

• 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.

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

Secondary Outcomes (9)

• Incidence and severity of adverse events (AEs)

  Baseline up to 5 years

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

  From pre-dose to 22 days after the first dose

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

  From pre-dose to 22 days after the first dose

• Immunogenicity

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

• ORR determined by investigators according to RECIST v1.1

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

Study Arms (2)

MHB046C (Phase I: Dose escalation)

EXPERIMENTAL

There are six escalating dose cohorts.

Drug: MHB046C

MHB046C (Phase II: Dose expansion)

EXPERIMENTAL

The recommended dose from the dose-escalation stage and other potential doses will be further explored.

Drug: MHB046C

Interventions

MHB046C DRUG

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.

MHB046C (Phase I: Dose escalation); MHB046C (Phase II: Dose expansion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Minghui Pharmaceutical (Hangzhou) Ltd: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Central Study Contacts

VP of R&D

CONTACT

86 0571-86963293; jwshi@minghuipharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 22, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2031
• Last Updated: September 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)