A Study of MHB036C Combined With MHB039A in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors
Recruiting
Phase 2Interventional Study
Advanced Breast CancerAdvanced Malignant Solid Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
210 (estimated)
Sponsor
Minghui Pharmaceutical (Hangzhou) Ltd · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is an open-label, multicenter Phase II study of MHB036C combined with MHB039A in patients with advanced Breast Cancer or other advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MHB036C and MHB039A combination therapy.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
1. Voluntarily agrees to participate in the study and signs the informed consent form.
2. Age ≥ 18 and ≤75 years, no restriction on gender.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Estimated life expectancy ≥ 3 months.
5. Histologically or cytol…
Inclusion Criteria:
1. Voluntarily agrees to participate in the study and signs the informed consent form.
2. Age ≥ 18 and ≤75 years, no restriction on gender.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Estimated life expectancy ≥ 3 months.
5. Histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors.
6. At least one measurable lesion per RECIST v1.1 criteria.
7. Adequate bone marrow reserve and organ function.
8. Eligible participants of childbearing potential (males and females) must agree to take highly reliable contraceptive measures with their partners during the study and within at least 12 weeks after the last dose.
\-
Exclusion Criteria:
1. History of ≥2 primary malignancies within 5 years prior to informed consent.
2. Received anti-tumor treatment within 4 weeks or within the 5 half-lives of the previous treatment (whichever is shorter) before dosing.
3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.
4. Undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks before dosing or requiring elective surgery during the study.
5. Vaccinated with attenuated live vaccines within 4 weeks before dosing.
6. Treated with with systemic corticosteroids within 14 days before dosing.
7. Central nervous system metastasis.
8. Uncontrolled third-space effusion.
9. Serious cardiovascular or cerebrovascular diseases.
10. Severe lung disease affecting pulmonary function.
11. Active infection requiring systemic therapy.
12. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
13. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
14. Known alcohol or drug dependence.
15. Pregnant or breastfeeding women, or individuals planning to conceive.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.