Study of MHB088C for Patients With Advanced Solid Malignant Tumors

NCT ID: NCT07102004

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 515 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2027-07-31

Brief Summary

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

Conditions

Advanced/Metastatic Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

MHB088C for Injection

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lin Shen, Ph.D

Role: CONTACT

doctorshenlin@sina.cn

13911219511

Facility Contacts

lin shen

Role: primary

doctorshenlin@sina.cn

13911219511

Other Identifiers

MHB088C-CP001CN

Identifier Type: -

Identifier Source: org_study_id