Advanced/Metastatic Solid Tumors
Conditions
Brief summary
This is a Phase I/II, multicenter, open-label clinical trial with dose escalation/dose expansion/efficacy expansion phases, designed to evaluate the safety/tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of MHB088C in participants with advanced solid tumors
Interventions
MHB088C for Injection, an antibody drug-conjugated molecule (ADC) MHB088C will be administered intravenously at a frequency of once every 2 weeks (Q2W) or every 3 week (Q3W).
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form; * Age ≥ 18 years old when signing the informed consent form; * The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\ 1; * The expected survival time is at least 3 months; * Eligible participants of childbearing potential must agree to take highly reliable contraceptive measures 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 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 * Phase Ia: 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. * Phase Ib: Histologically or cytologically confirmed unresectable advanced or metastatic malignant solid tumors, that is relapsed or progressed following systemic treatment or no SOC is available; * Phase II: Histologically or cytologically documented unresectable advanced or metastatic SCLC and previous progressed during or after platinum-contained chemotherapy and immune-checkpoint inhibitors (ICIs).
Exclusion criteria
* Has more than 2 primary malignancies before signing of Informed Consent Form. * Has received anti-tumor treatment before the first dose of investigational product; Medication of traditional Chinese medicine before the first dose of investigational drug. * Medication of other unmarketed investigational drugs or therapies before the first dose of investigational drug. * Presence of unstable brain metastases and/or leptomeningeal carcinomatosis. * Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1; * Has underwent major organ surgery or significant trauma before the first dose of investigational drug or requiring elective surgery during the study. * Has vaccinated with attenuated live vaccines before the first dose of investigational drug. * Has mucosal or internal bleeding for non-traumatic reason before the first dose of investigational drug. * Has received treatment with systemic corticosteroids or other immunosuppressive agents before the first dose of investigational drug. * Has pulmonary disease that severely impact pulmonary function. * Has history of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonia, or suspected ILD/pneumonia that cannot be excluded by imaging examination at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event (AE) and Serious adverse event (SAE) (Phase Ia) | After first administration of study drug until 30 days after last dose of study drug. Through phase Ia completion, an average of 1 year. | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) |
| Dose limited toxicity (DLT) (Phase Ia) | Cycle 1 (28 days for subjects receiving a dosing frequency of every 2 weeks, or 21 days for subjects receiving a dosing frequency of every 3 weeks) | The DLTs of MHB088C will be determined. |
| Maximum tolerated dose (MTD) (Phase Ia) | Cycle 1 (28 days for subjects receiving a dosing frequency of every 2 weeks, or 21 days for subjects receiving a dosing frequency of every 3 weeks). | The maximum tolerated dose (MTD) of MHB088C will be evaluated on the first cycle. |
| Recommended phase II dose (RP2D) (Phase Ib) | Through phase Ib completion, an average of 1 year. | RP2D will be selected upon safety, PK and efficacy data. |
| Objective response rate (ORR) (phase II) | Approximately 48 months. | The ORR is defined as the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR), based on RECIST Version 1.1 |
Countries
China
Contacts
Primary ContactLin Shen, Ph.D
Outcome results
None listed