NCT07102004 Study of MHB088C for Patients With Advanced Solid Malignant Tumors
| NCT ID | NCT07102004 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Advanced/Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 515 participants |
| Start Date | 2023-06-20 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 515 participants in total. It began in 2023-06-20 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07102004 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced/Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07102004 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07102004 currently recruiting?
Yes, NCT07102004 is actively recruiting participants. Contact the research team at doctorshenlin@sina.cn for enrollment information.
Where is the NCT07102004 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07102004 clinical trial?
NCT07102004 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 515 participants.