Study of MHB088C in Participants With Advanced or Metastatic Solid Tumors

NCT05652855 | Not Yet Recruiting Phase 1

• 1 other identifier: MHB088C-CP001EN
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Evaluate the incidence of adverse events (AEs)

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

  through study completion, an average of 1 year

• 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

  through study completion, an average of 1 year

• Determine the recommended Phase 2 dose (RP2D) of MHB088C

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

  through study completion, an average of 1 year

Secondary Outcomes (11)

• Pharmacokinetics (PK) parameter: Maximum concentration (Cmax)

  Within 5 cycles (each cycle is 28 days)

• PK parameter: Time to maximum concentration (Tmax)

  Within 5 cycles (each cycle is 28 days)

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

  Within 5 cycles (each cycle is 28 days)

• PK parameter: Trough concentration (Ctrough)

  Within 5 cycles (each cycle is 28 days)

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

  Within 5 cycles (each cycle is 28 days)

Study Arms (1)

MHB088C administered

EXPERIMENTAL

MHB088C will be administered intravenously at a frequency of once every 2 weeks (Q2W).

Drug: MHB088C for Injection

Interventions

MHB088C for Injection DRUG

MHB088C for Injection, an antibody drug-conjugated molecule (ADC)

MHB088C administered

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• 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.
• 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.
• Histologically or cytologically documented unresectable advanced or metastatic ESCC previous progressed during or after≥1 line platinum-based of systemic treatment.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Minghui Pharmaceutical Pty Ltd: lead

Study Sites (3)

Pindara Private Hospital

Gold Coast, Queensland, 4217, Australia

Location

Southern Oncology Clinical Research Unit

Adelaide, South Australia, 5042, Australia

Location

Cabrini Health

Melbourne, Victoria, 3144, Australia

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Contact for Clinical Trial Information Minghui Pharmaceutical

CONTACT

086-02160898367; minghui_ra@minghuipharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group contains two study parts

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 15, 2022
• Study Start: January 23, 2023
• Primary Completion: January 31, 2026
• Study Completion: July 31, 2026
• Last Updated: January 9, 2023

Record last verified: 2023-01

Locations

AU (3)