Advanced/Metastatic Solid TumorsPhase 1/2NCT07102004
Study of MHB088C for Patients With Advanced Solid Malignant Tumors
A Phase 1/2 study testing MHB088C for Injection in people with Advanced/Metastatic Solid Tumors, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced/Metastatic Solid Tumors
- What is being tested?
- MHB088C for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 515 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2023to Jul 2027
- 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
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
lin shen, 13911219511, doctorshenlin@sina.cn
About this study
Official title: 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
- Conditions
- Advanced/Metastatic Solid Tumors
- Being tested
- MHB088C for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHB088C for InjectionDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| MHB088C administered | Experimental | 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 Receives: Drug: MHB088C for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event (AE) and Serious adverse event (SAE) (Phase Ia)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Approximately 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start20 Jun 2023
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 515 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102004
- Sponsor's protocol ID
- MHB088C-CP001CN
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of MHB088C for Patients With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07102004
- Acronym / sponsor ID
- MHB088C-CP001CN
- Conditions
- Advanced/Metastatic Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 515 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MHB088C administered | Experimental | Drug: MHB088C for InjectionIf 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MHB088C for InjectionMHB088C 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). | Drug | MHB088C administered |
Primary outcome
Adverse event (AE) and Serious adverse event (SAE) (Phase Ia)
Time frame: After first administration of study drug until 30 days after last dose of study drug. Through phase Ia completion, an average of 1 year.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Dose limited toxicity (DLT) (Phase Ia)
Time frame: 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)
The DLTs of MHB088C will be determined.
Maximum tolerated dose (MTD) (Phase Ia)
Time frame: 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).
The maximum tolerated dose (MTD) of MHB088C will be evaluated on the first cycle.
Recommended phase II dose (RP2D) (Phase Ib)
Time frame: Through phase Ib completion, an average of 1 year.
RP2D will be selected upon safety, PK and efficacy data.
Objective response rate (ORR) (phase II)
Time frame: Approximately 48 months.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MHB088C for Injection in people with Advanced/Metastatic Solid Tumors, run by Qilu Pharmaceutical Co., 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 10 inclusion and 11 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 3 Aug 2025. 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 Lin Shen, Ph.D (13911219511, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (AE) and Serious adverse event (SAE) (Phase Ia) (time frame: After first administration of study drug until 30 days after last dose of study drug. Through phase Ia completion, an average of 1 year.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.