Study of MHB088C for Patients With Advanced Solid Malignant Tumors

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: Recruiting
• Conditions: Advanced/Metastatic Solid Tumors
• Intervention / Treatment: Drug: MHB088C for Injection

• Study Type: Interventional
• Enrollment (Estimated): 515
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Lin Shen, Ph.D; Phone Number: 13911219511; Email: doctorshenlin@sina.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Cancer Hospital
    • Contact: lin shen; Phone Number: 13911219511; Email: doctorshenlin@sina.cn

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Adverse event (AE) and Serious adverse event (SAE) (Phase Ia)	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)	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)	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)	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)	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

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: July 28, 2025
• First Submitted That Met QC Criteria: July 28, 2025
• First Posted (Actual): August 3, 2025

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID 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