Study of MHB036C in Participants With Advanced or Metastatic Solid Tumors

NCT05642949 | Not Yet Recruiting Phase 1

• 1 other identifier: MHB036C-CP001EN
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate the safety, pharmacokinetics, and anti-tumor efficacy of MHB036C in participants with advanced or metastatic solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events

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

  From the day of the first dose of MHB036C to 30 days after the day of the last dose of MHB036C

• Number of participants with dose-limiting toxicities

  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

  21 days after the first dose of MHB036C

Secondary Outcomes (11)

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

  Within 5 cycles (each cycle is 21 days)

• PK parameter: Time to maximum concentration (Tmax)

  Within 5 cycles (each cycle is 21 days)

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

  Within 5 cycles (each cycle is 21 days)

• PK parameter: Trough concentration (Ctrough)

  Within 5 cycles (each cycle is 21 days)

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

  Within 5 cycles (each cycle is 21 days)

Study Arms (2)

Dose Escalation - All Participants

EXPERIMENTAL

All participants enrolled in the dose escalation part.

Drug: MHB036C

Dose Expansion - All Participants

EXPERIMENTAL

All participants enrolled in the dose expansion part

Drug: MHB036C

Interventions

MHB036C DRUG

MHB036C will be administered intravenously at a frequency of once every 3 weeks (Q3W).

Dose Escalation - All Participants; Dose Expansion - All Participants

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 (ICF).
• Participants aged 18 years or older (inclusive), without gender limitation.
• Participants with ECOG performance score of 0 \~ 1.
• Participants with expected survival time of more than 3 months.
• Eligible participants of childbearing potential (males and females) must agree to take 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; female participants of childbearing potential must have a negative results of blood pregnancy test within 7 days before the first dose of the investigational product, and must be non-lactating.
• Participants who are able to understand study requirements, and willing and able to comply with arrangements of study and follow-up procedures.
• Neoplasm-related criteria
• Participants to be enrolled in part one must have histologically or cytologically confirmed advanced or metastatic solid tumors, which have failed or are intolerant to standard of care (SOC), or for which no SOC is available;
• Participants to be enrolled in part two must have histologically or cytologically confirmed advanced or metastatic solid tumors, including but not limited to the following types: non-small cell lung cancer (NSCLC); small cell lung cancer (SCLC); pancreatic ductal adenocarcinoma (PDAC); head and neck squamous cell carcinoma (HNSCC); esophageal squamous cell carcinoma (ESCC); urothelial carcinoma (UC); ovarian cancer (OC); endometrial cancer (EC); breast cancer (BC); gastric cancer (GC); castration-resistant prostate cancer (CRPC); sweat gland carcinoma (SGC).
• Additional criteria for enrollment of participants with NSCLC:
• Participants with unresectable advanced NSCLC who have failed standard of care with platinum doublet chemotherapy and immune-checkpoint inhibitors (ICIs), and are not suitable for radical therapy (NSCLC participants with driver gene mutations should have failed or are intolerant to targeted therapy for the corresponding driver gene mutation, or unsuitable for the corresponding targeted therapy as per investigator's evaluation ).
• Additional criteria for enrollment of participants with SCLC:
• Participants with unresectable or metastatic SCLC who have previously received at least one line of systemic chemotherapy, including platinum-based chemotherapy and immune-checkpoint inhibitors (ICIs)

You may not qualify if:

• Neoplasm-related criteria:
• Participants with 2 or more malignancies (except effectively treated non-melanoma skin cancer, cervical carcinoma in situ or other tumors, or malignancies considered cured) within 5 years prior to sign the Informed Consent Form.
• Participants who have received chemotherapy within 3 weeks prior to the first dose of investigational product, or have received target therapy within 2 weeks prior to the first dose, or have received anti-tumor therapy including radiation therapy, biologic therapy, endocrine therapy, immunotherapy, etc. within 4 weeks prior to the first dose; or participants with the following conditions:
• Medication of nitrosourea or mitomycin C within 6 weeks prior to the first dose of MHB036C;
• Medication of oral fluoropyrimidines or small molecule targeted agents within 5 half-lives of such drug before first dose of investigational product.
• Medication of traditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first dose of investigational product.
• Medication of other unmarketed investigational products or therapies within 4 weeks prior to the first dose of investigational product.
• Presence of brain metastases and/or carcinomatous meningitis. 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 prior to the first dose of investigational product, all neurological symptoms have recovered, no evidence of new or enlarging brain metastases, and radiation or surgical had been discontinued for at least 14 days prior to the first dose of investigational product, or with steroid therapy ≤10 mg/day prednisone or equivalent dose of similar drugs within 14 days prior to the first dose of investigational product or during the study. This exception does not include carcinomatous meningitis, which should be excluded regardless of clinical stability.
• Participants previously received same targeted therapy will be excluded.
• Participants with adverse reactions from previous anti-tumor therapy that have not recovered to ≤Grade 1 as per CTCAE 5.0 (except for toxicities without safety risks as determined by the investigator, such as alopecia, hypothyroidism stably managed by hormone replacement therapy, etc.).
• General conditions:
• Participants underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to the first dose of investigational product or require elective surgery during the study.
• Participants vaccinated with attenuated live vaccines (except for SARS-CoV-2 vaccination) within 4 weeks prior to the first dose of investigational product.
• Participants received treatment with systemic corticosteroids (prednisone at \> 10 mg/day, or similar drugs at equivalent dose) or other immunosuppressive agents within 14 days prior to the first dose of investigational product, with the following exceptions:
• Treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids;

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

Central Study Contacts

Minghui Pharmaceutical Contact for Clinical Trial Information

CONTACT

086-02160898367; minghui_ra@minghuipharma.com

Study Design

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

Model Details: Single group, but in two study parts, therefore two sequential arms are identified

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: January 23, 2023
• Primary Completion: December 31, 2025
• Study Completion: June 30, 2026
• Last Updated: January 9, 2023

Record last verified: 2023-01

Locations

AU (3)