Phase I/II, dose escalation and dose expansion study to evaluate the efficacy and safety of MHB036C in advanced malignant tumors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.).
Primary outcome measure(s)
Incidence of participants with adverse events (AE) — Until 30 days after last dose of MHB036C An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Number of participants with dose-limiting toxicity (DLT) — At the end of Cycle 1 (each cycle is 21 days) DLTs will be assessed during the dose-escalation phase and are defined as toxicities related to MHB036C which meet pre-defined severity criteria and occurs within the first cycle of treatment
Trial sites (1)
Facility
City
Region
Status
Shanghai Chest Hospital
Shanghai
China
More Minghui Pharmaceutical (Hangzhou) Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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