Evaluating MHB036C for advanced solid tumors

A Phase I/II, Dose Escalation and Dose Expansion Study of MHB036C for Advanced Solid Tumor to Evaluate the Tolerability/Safety, Pharmacokinetics and Efficacy

This study is testing a new drug called MHB036C to see if it can safely help people with advanced solid tumors.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd (industry)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Shanghai)
• Trial ID: NCT06373406 on ClinicalTrials.gov

What this trial studies

This is a Phase I/II clinical trial designed to assess the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and anti-tumor activity of MHB036C in patients with advanced solid tumors. The study will begin with a dose escalation phase to identify the maximum tolerated dose, followed by a dose expansion phase to evaluate the recommended Phase 2 dose based on safety and efficacy in specific tumor types. Participants will be closely monitored throughout the trial to gather comprehensive data on the drug's effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors and an Eastern Cooperative Oncology Group performance score of 0-1.

Not a fit: Patients with a life expectancy of less than 3 months or those unable to comply with study requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors.

How similar studies have performed: While this approach is novel, similar studies targeting advanced solid tumors have shown promise in evaluating new therapies.

Eligibility criteria

Inclusion Criteria:

* 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 Eastern Cooperative Oncology Group 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.
* 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;

Exclusion 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 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 disapproved 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 4 weeks, no evidence of new or enlarging brain metastases, or without steroid therapy within 14 days prior to the first dose of investigational product. 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.).

Where this trial is running

Shanghai

• Shanghai Chest Hospital — Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Shun Lu — Shanghai Chest Hospital
• Study coordinator: Shun Lu

Conditions: Advanced Solid Tumor