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Trial Title:
A Study of MHB036C for Advanced Solid Tumor
NCT ID:
NCT06373406
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MHB036C
Description:
An antibody-drug conjugate therapy
Arm group label:
MHB036C
Summary:
Phase I/II, dose escalation and dose expansion study to evaluate the efficacy and safety
of MHB036C in advanced malignant tumors.
Detailed description:
This first-in-human, dose escalation and dose expansion study is to evaluate the safety,
tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor
activity of MHB036C in patients with advanced solid tumor. The Phase I stage is to
determine the maximum tolerated dose (MTD). The phase II stage is to determine the
recommended Phase 2 dose (RP2D) according to safety and efficacy in specific tumor types.
Criteria for 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.).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Shun Lu, MD
Phone:
13601813062
Email:
shun_lu@hotmail.com
Start date:
May 18, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Minghui Pharmaceutical (Hangzhou) Ltd
Agency class:
Industry
Source:
Minghui Pharmaceutical (Hangzhou) Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06373406
