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Advanced or Metastatic Solid TumorsPhase 1/2NCT05652855

Study of MHB088C in Participants With Advanced or Metastatic Solid Tumors

A Phase 1/2 study testing MHB088C for Injection in people with Advanced or Metastatic Solid Tumors, run by Minghui Pharmaceutical Pty Ltd at 3 sites in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will evaluate the safety/tolerability, pharmacokinetics and efficacy of MHB088C in participants with advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced or 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
48 participants
Where
3 sitesAustralia
Study dates
23 Jan 2023to 31 Jul 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • -
  • Participants enrolled must meet all of the following criteria:
  • General conditions
  • Participants voluntarily agree to participate in the study and sign the Informed Consent Form.
  • Aged ≥18years, without gender limitation.
  • Has an Eastern Cooperative Oncology Group Performance score (ECOG) 0 ~ 1.
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  • Has a life expectancy of ≥ 3 months.
  • Eligible participants of childbearing potential (males and females) must agree to take highly reliable contraceptive measures (hormone or barrier method, or absolute abstinence, etc.) 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 within 7 days 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
  • Part one: 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;
  • Part two: Histologically or cytologically confirmed unresectable advanced or metastatic malignant solid tumors, that is relapsed or progressed following systemic treatment or no standard of care is available, including but not limited to the following types: non-small cell lung cancer (NSCLC); small cell lung cancer (SCLC); esophageal squamous cell carcinoma (ESCC); castration-resistant prostate cancer (CRPC); melanoma (MEL); colorectal cancer (CRC); pancreatic ductal adenocarcinoma (PDAC); head and neck squamous cell carcinoma (HNSCC); hepatocellular carcinoma (HCC); ovarian cancer (OC); endometrial cancer (EC); thyroid cancer (TC); and sarcoma (SARC).
  • Additional inclusion criteria for participants with NSCLC:
  • Histologically or cytologically documented unresectable advanced or metastatic NSCLC and previous progressed during or after systematic treatment with platinum-contained doublet regimens chemotherapy and immune-checkpoint inhibitors (ICIs); refractory, intolerant or not suitable to the target therapy as per investigator discretion for participants with driver gene mutation.
  • Additional inclusion criteria for participants with SCLC:
  • Histologically or cytologically documented unresectable advanced or metastatic SCLC and previous progressed during or after ≥1 lines of systematic treatment with platinum-based, doublet regimens chemotherapy and ICIs.
  • Additional inclusion criteria for participants with ESCC:
  • Histologically or cytologically documented unresectable advanced or metastatic ESCC previous progressed during or after≥1 line platinum-based of systemic treatment.
  • Additional inclusion criteria for participants with CRPC:
  • Histologically or cytologically documented CRPC without neuroendocrine differentiation or small cell elements; Underwent surgical or medical castration, with testosterone levels below 50 ng/dL; Objective progression as determined by radiographic after androgen deprivation therapy; Relapsed or progressed during or after at least one of the following medicines: abiraterone, enzalutamide, apalutamide, or darolutamide; Relapsed or progressed during or after≥ 1 line of docetaxel/mitoxantrone-based cytotoxic chemotherapy regimens for metastatic CRPC; With at least 1 documented lesion confirmed by either a bone scan or a CT/MRI scan.
  • Additional inclusion criteria for participants with MEL:
  • Histologically or cytologically documented unresectable advanced or metastatic MEL and previous progressed during or after ≥1 line of systemic therapy including ICIs
  • Additional inclusion criteria for participants with CRC:
  • Histologically or cytologically documented unresectable advanced or metastatic CRC and previous progressed during or after systematic chemotherapy containing oxaliplatin, irinotecan, fluorouracil and immunotherapy (for participants with MSI-H/dMMR).
  • Additional inclusion criteria for participants with PDAC:
  • Histologically or cytologically documented unresectable advanced or metastatic PDAC and previous progressed during or after ≥ 1 line of systemic therapy in neoadjuvant, adjuvant, locally advanced or metastatic setting.
  • Additional inclusion criteria for participants with HNSCC:
  • Histologically or cytologically documented unresectable advanced or metastatic HNSCC and previous progressed during or after ≥ 1 line of systemic therapy, including platinum-based chemotherapy and ICIs (combined or sequential therapy).
  • Additional inclusion criteria for participants with HCC:
  • Histologically or cytologically documented unresectable advanced or metastatic HCC and previously progressed during or after ≥ 1 line of systemic therapy, including anti-vascular therapy and/or ICI therapy.
  • Additional inclusion criteria for participants with OC:
  • Histologically or cytologically documented unresectable advanced or metastatic OC including less-common histology per National Comprehensive Cancer Network (NCCN) of epithelial ovarian cancer as well as fallopian tube cancer and primary peritoneal cancer and have relapsed or progressed during or after ≥ 1 line of platinum-based systemic chemotherapy treatment.
  • Additional inclusion criteria for participants with EC:
  • Histologically or cytologically documented unresectable advanced or metastatic EC and recurrence after radical therapy, and previously treated and progressed during or after ≥ 1 line of standard systemic therapy.
  • Additional inclusion criteria for participants with TC:
  • Histologically or cytologically documented unresectable advanced or metastatic TC and previous progressed during or after ≥ 1 line of systemic therapy including platinum-based chemotherapy or targeted therapy.
  • Additional inclusion criteria for participants with SARC:
  • Histologically or cytologically documented unresectable advanced or metastatic SARC and previous progressed during or after ≥ 1 prior line of systemic therapy including doxorubicin-based chemotherapy.
  • Agree to provide the pre-existing diagnostic tumor samples for retrospective testing of target expression and other biomarkers (participants who agree but are unable to provide pre-existing tumor sample may also be enrolled). There is no minimum target expression level required for inclusion.
  • Has at least one measurable tumor lesion as per RECIST v1.1(generally, previously irradiated areas or locoregionally treated sites will not be considered as measurable lesions, unless these lesions have clearly progressed or still exist three months after radiotherapy); for participants with CRPC, evaluable lesions as defined by PCWG3 criteria or at least one measurable soft tissue tumor lesion as per RECIST v1.1 are required.
  • Adequate bone marrow reserve and organ functions:
  • Adequate bone marrow reserve (without transfusion or colony-stimulating factor or equivalent within7 days before the screening period testing); Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 9.0 g/dL.
  • Adequate hepatic function (with reference to normal values specified by the clinical study site):
  • Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); TBIL ≤ 2 × ULN if Gilbert's syndrome is present; TBIL ≤ 3.0 × ULN is permitted if direct bilirubin (DBIL) suggests extrahepatic obstruction.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) shall be ≤ 3 × ULN with non-hepatic tumors and without hepatic metastasis; AST and ALT shall be ≤ 5.0 × ULN with hepatic tumors or hepatic metastasis;
  • Adequate renal function (with reference to normal values specified by the clinical study site):
  • Creatinine (Cr) ≤ 1.5 × ULN; when Cr > 1.5 × ULN, only participants with creatinine clearance (Ccr) ≥ 50 mL/min can be enrolled (using Cockcroft-Gault formula);
  • Adequate coagulation function:
  • Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, and international normalized ratio (INR) ≤ 1.5 × ULN.
  • Adequate cardiac function:
  • Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram within 28 days before enrollment; New York Heart Association (NYHA) Class < grade 3.

Who cannot join

  • -
  • Participants will be not enrolled if they meet any of the following exclusion criteria:
  • Neoplasm-related criteria:
  • Has more than 2 primary malignancies (except curatively treated non-melanoma skin cancer, in situ disease, and other curatively malignancies have considered cured) within 5 years before signing of Informed Consent Form.
  • Has received chemotherapy within 3 weeks, or have received anti-tumor treatment including radiation therapy, biologic therapy, endocrine therapy, immunotherapy, etc. within 4 weeks before the first dose of investigational product; or participants with the following conditions:
  • Medication of nitrosourea or mitomycin C within 6 weeks before the first dose of investigational drug; Medication of oral fluoropyrimidines and small molecule targeted agents within 5 half-lives before the first dose of investigational drug; Medication of traditional Chinese medicine with anti-tumor indication within 2 weeks before the first dose of investigational drug.
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  • Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug.
  • Presence of brain metastases and/or leptomeningeal carcinomatosis. Participants previously treated for brain metastases may be considered to be enrolled in this study, provided they have been in stable condition for at least 1 month, have no progression confirmed by radiographic examination within 4 weeks before the first dose of study treatment, all neurological symptoms have stabled, there is no evidence of new or enlarging brain metastases, and radiation or surgical therapy is discontinued for at least 28 days before the first dose of study treatment and steroid therapy at the dose of ≤10 mg/day or similar drugs at equivalent dose within 14 days before the first dose and during the study. This exception does not include carcinomatous meningitis, which should be excluded regardless of clinical stability.
  • Has previously received same target therapy.
  • Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1 (except for toxicities without safety risks as determined by the investigator, such as alopecia, hypothyroidism stably managed by hormone replacement therapy, etc.).
  • General conditions:
  • Has 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.
  • Has vaccinated with attenuated live vaccines (except for SARS-CoV-2 vaccination) within 4 weeks before the first dose of investigational drug.
  • Has mucosal or internal bleeding for non-traumatic reason within 4 weeks before the first dose of investigational drug.
  • Has received treatment with systemic corticosteroids (prednisone at >10 mg/day, or similar drugs at equivalent dose) or other immunosuppressive agents within 14 days before the first dose of investigational drug, with the following exceptions:
  • Treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; Short-term use of glucocorticoids for prophylaxis (e.g., prevention of contrast media allergy).
  • Has pulmonary disease that severely impact pulmonary function, including, but not limited to, potential pulmonary disease, any autoimmune diseases, connective tissue diseases, or inflammatory diseases involving the pulmonary, or pneumonectomy.
  • 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.
  • Has active pulmonary tuberculosis.
  • Has active infection requiring systemic therapy.
  • Has positive results in virus serology tests (participants receiving antiviral prophylaxis other than interferon are allowed to be enrolled):
  • Positive result of HIV antibody; Or, positive for both HBsAg and HBV-DNA (i.e., HBV DNA ≥LLOD); Or, positive for HCV Ab (except HCV-RNA < LLOD).
  • Has positive result for covid-19 nucleic acid test.
  • Medical history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
  • Severe arrhythmia or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, or atrioventricular block Ⅱ~Ⅲ degree; Fridericia-corrected QT interval (QTcF) prolongation to >450 milisecond (ms) for males and > 470 ms for females; Acute coronary syndrome, aortic dissection, stroke or transient ischemic attack (TIA) within 6 months before the first dose; New myocardial infarction or unstable angina within 6 months before the first dost; Clinically uncontrolled hypertension;
  • Has clinically uncontrolled effusion in third spacing, deemed as inappropriate for enrollment by the investigator.
  • Hypersensitivity or delayed hypersensitivity to certain components or analogues of the investigational drug.
  • Has drug abuse or any other medical conditions, such as clinically significant psychological conditions that may interfere with study participation or the results of the clinical study as per investigator discretion.
  • Has alcohol or drug dependence.
  • Females who are pregnant or breastfeeding, or males/females who plan to father a child/get pregnant.
  • Poor compliance as per investigator discretion, has history of other serious systemic diseases, or unsuitable to participate this clinical study for some reasons.

Trial locations and contacts

3 sites in 1 country.

Contact for Clinical Trial Information Minghui Pharmaceutical contact

086-02160898367

minghui_ra@minghuipharma.com

Australia3 sites

  • Southern Oncology Clinical Research Unit

    Adelaide, South Australia, 5042

    Ganessan Kichenadasse, Dr, 0491 679 039, clinicaltrials@socru.org.au

    Ganessan Kichenadasse

  • Pindara Private Hospital

    Gold Coast, Queensland, 4217

    Andrea Tazbirkova, Dr, 0755971211, tazbirkova@yahoo.com.au

    Andrea Tazbirkova, Dr

  • Cabrini Health

    Melbourne, Victoria, 3144

    Gary Richardson, Prof, 0400904111, Gary.richardson@ocv.net.au

    Gary E Richardson, Prof

Other trials in Australia

About this study

Official title: Phase 1/2, Two-Part, Multi-center, Open-label, Dose Escalation and Dose Expansion First-In-Human Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Efficacy of MHB088C in Participants With Advanced or Metastatic Solid Tumors

This study will evaluate the safety/tolerability, pharmacokinetics and efficacy of MHB088C in participants with advanced or metastatic solid tumors.

Read the detailed description

This study is the first-in-human (FIH) trial of MHB088C, which contains two parts: dose escalation (part one) and dose expansion (part two).

Part one: Dose Escalation Study of MHB088C Monotherapy in Participants with Advanced or Metastatic Malignant Solid Tumors The dose escalation part is an open-label, multi-center study in which the eligible participants with advanced or metastatic solid tumors will be enrolled to receive MHB088C monotherapy to assess the safety and tolerability of MHB088C in participants with advanced or metastatic solid tumors, to determine the maximum tolerated dose (MTD) of MHB088C, and to assess its pharmacokinetic profile and preliminary efficacy.

The dose expansion part is an open-label, multi-center, multi-cohort expansion study in which participants with advanced or metastatic solid tumors of some predefined cancer types will be enrolled to receive MHB088C monotherapy. Participants with same types of solid tumors will be randomised into different selected dose groups and will be treated with the corresponding dose. This study is designed to assess the preliminary efficacy and safety of MHB088C monotherapy in participants with some types of advanced or metastatic solid tumors, so as to determine the recommended phase 2 dose (RP2D); and to assess the immunogenicity and pharmacokinetic profiles of MHB088C.

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)

Study groups in NCT05652855
Study groupRoleWhat they receive
MHB088C administeredExperimentalMHB088C will be administered intravenously at a frequency of once every 2 weeks (Q2W).
Receives: Drug: MHB088C for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the incidence of adverse events (AEs)

    Adverse events was assessed by investigator(s) according to NCI-CTCAE v5.0

    Measured: through study completion, an average of 1 year

  2. Evaluate the incidence of dose-limiting toxicities (DLTs)

    Dose-limiting toxicities are defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment

    Measured: through study completion, an average of 1 year

  3. Determine the recommended Phase 2 dose (RP2D) of MHB088C

    The recommended phase 2 dose (RP2D) is determined traditionally by dose-limiting toxicities.

    Measured: through study completion, an average of 1 year

Secondary outcomes (11)

  1. Pharmacokinetics (PK) parameter: Maximum concentration (Cmax)

    MHB088C, total antibody, free toxin MH30010008

    Measured: Within 5 cycles (each cycle is 28 days)

  2. PK parameter: Time to maximum concentration (Tmax)

    MHB088C, total antibody, free toxin MH30010008

    Measured: Within 5 cycles (each cycle is 28 days)

  3. PK parameter: Area under the concentration-time curve (AUC)

    MHB088C, total antibody, free toxin MH30010008

    Measured: Within 5 cycles (each cycle is 28 days)

  4. PK parameter: Trough concentration (Ctrough)

    MHB088C, total antibody, free toxin MH30010008

    Measured: Within 5 cycles (each cycle is 28 days)

  5. PK parameter: Terminal or apparent terminal half-life (t1/2)

    MHB088C, total antibody, free toxin MH30010008

    Measured: Within 5 cycles (each cycle is 28 days)

  6. PK parameter: Systemic clearance (CL)

    MHB088C, total antibody, free toxin MH30010008

    Measured: Within 5 cycles (each cycle is 28 days)

  7. Immunogenicity Assessment

    Assessment of anti-drug antibody (ADA)

    Measured: Within 5 cycles (each cycle is 28 days)

  8. Objective Response Rate (ORR)

    Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)

    Measured: through study completion, an average of 1 year

  9. Duration of Response (DOR)

    DOR was defined as the time from first assessment of PR or CR until disease progression.

    Measured: through study completion, an average of 1 year

  10. Disease Control Rate (DCR)

    DCR was defined as the proportion of participants with a complete response (CR), partial response (PR) or stable disease (SD).

    Measured: through study completion, an average of 1 year

  11. Progression Free Survival (PFS)

    Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2022
  2. Study start23 Jan 2023 (estimated)
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

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
Model description
Single group contains two study parts
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05652855
Sponsor's protocol ID
MHB088C-CP001EN
Status last verified
Jan 2023
First submitted
30 Nov 2022
Last updated
9 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MHB088C for Injection in people with Advanced or Metastatic Solid Tumors, run by Minghui Pharmaceutical Pty Ltd at 3 sites in Australia.

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 51 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Contact for Clinical Trial Information Minghui Pharmaceutical (086-02160898367, minghui_ra@minghuipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the incidence of adverse events (AEs) (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05652855.

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 9 Jan 2023.

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