A Study of MHB088C Combined With MHB039A in Patients With Advanced Malignant Solid Tumors

NCT07126665 | Recruiting Phase 1

• 1 other identifier: MHB088C-E-102
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first-in-human, open-label, multicenter Phase I/II study of MHB088C combined with MHB039A in patients with advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB088C and MHB039A combination therapy.

Conditions

Advanced Malignant Solid Tumor

Outcome Measures

Primary Outcomes (2)

• (Dose-Escalation Stage): Dose-Limiting Toxicity (DLT) and Maximum tolerated dose (MTD) for MHB088C and MHB039A combination therapy

  To determine the MTD for further evaluation of IV administration of MHB088C and MHB039A combination therapy in subjects with advanced solid tumors.

  Up to day 21 from the first dose for Q3W administration, or up to day 28 from the first dose for Q2W administration.

• (Dose-Expansion Stage): Objective tumor response (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).

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

Secondary Outcomes (7)

• Incidence and severity of adverse events (AEs)

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

• Duration of response (DOR) 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

• Disease control rate (DCR) 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 (4)

Dose escalation phase: cohort 1

EXPERIMENTAL

Subjects will receive MHB088C Q2W in combination with MHB039A Q2W by intravenous administration.

Drug: MHB088C for Injection; Drug: MHB039A for Injection

Dose escalation phase: cohort 2

EXPERIMENTAL

Subjects will receive MHB088C Q2W in combination with MHB039A Q2W by intravenous administration.

Drug: MHB088C for Injection; Drug: MHB039A for Injection

Indication expansion phase: cohort 3

EXPERIMENTAL

Subjects will receive MHB088C Q2W in combination with MHB039A Q2W by intravenous administration.

Drug: MHB088C for Injection; Drug: MHB039A for Injection

Indication expansion phase: cohort 4

EXPERIMENTAL

Subjects will receive MHB088C Q2W in combination with MHB039A Q2W by intravenous administration.

Drug: MHB088C for Injection; Drug: MHB039A for Injection

Interventions

MHB088C for Injection DRUG

Intravenous administration

Dose escalation phase: cohort 1; Dose escalation phase: cohort 2; Indication expansion phase: cohort 3; Indication expansion phase: cohort 4

MHB039A for Injection DRUG

Intravenous administration

Dose escalation phase: cohort 1; Dose escalation phase: cohort 2; Indication expansion phase: cohort 3; Indication expansion phase: cohort 4

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.
• For the dose escalation stage: Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
• For the dose expansion stage: Histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors, not suitable for radical surgery and/or radical concurrent/sequential radiotherapy and chemotherapy.
• At least one measurable lesion per RECIST v1.1 criteria.
• Adequate bone marrow reserve and organ function.
• Eligible participants of childbearing potential (males and females) must agree to take highly reliable contraceptive measures with their partners during the study and within at least 12 weeks after the last dose.

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, or biologic, endocrine, or immunotherapy within 4 weeks before dosing.
• Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.
• Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
• Underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose of investigational drug or requiring elective surgery during the study.
• Previous or concurrent gastrointestinal perforation, surgical procedures and wound healing complications, as well as bleeding events.
• Received intravenous thrombolysis treatment within 2 weeks, except for preventive anticoagulation and antiplatelet therapy.
• Vaccinated within 4 weeks before dosing.
• Treated with systemic corticosteroids within 14 days before dosing.
• Severe lung disease affecting pulmonary function.
• Active systemic infection requiring treatment within 7 days before dosing.
• Uncontrolled third-space effusion.
• Serious cardiovascular or cerebrovascular diseases.
• 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.

Sponsors & Collaborators

• Minghui Pharmaceutical (Hangzhou) Ltd: lead

Study Sites (1)

Ethics Committee of Shanghai East Hospital

Shanghai, Shanghai Municipality, 201419, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

VP of R&D

CONTACT

86 0571-869632; 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: August 11, 2025
• First Posted: August 17, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2031
• Last Updated: November 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)