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The goal of this clinical trial is to learn if the study drug can work in advanced cancer patients. The main questions it aims to answer are:
Participants will receive the study drug once every three weeks, and imaging-based efficacy assessments will be performed every six weeks.
Target population are patients with advanced solid tumors .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDM2024 | Experimental | HDM2024 ( the antibody-drug conjugate (ADC) drug targeting epidermal growth factor receptor (EGFR) & human epidermal growth factor receptor 3 (HER3) ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM2024 | Drug | ADC drug targeting EGFR and HER3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal tolerance dose (MTD) of HDM2024 | The MTD is defined as the dose level at which the estimated toxicity probability is closest to the target toxicity rate during the Dose-limiting toxicity (DLT) observation period of the dose escalation stage. | DLT will be evaluated on 21 days of observation period |
| Determination of the Recommended Phase 2 dose (RP2D) | Approximately 1 years | |
| Incidence and severity of Treatment-Emergent Adverse Events | Incidence rates of adverse events (AE), serious adverse events (SAE)per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0. | Approximately 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to peak (Tmax) of HDM2024 | Tmax of HDM2024, total antibody, and exatecan will be measured | Approximately 1 years |
| Half-life time (t1/2) of HDM2024 | t1/2 of HDM2024, total antibody, and exatecan will be measured |
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Inclusion Criteria:
Exclusion Criteria:
1. Participants who have previously received ADC containing exatecan , or an ADC primarily directed against EGFR and/or HER3.
2. Participants who have received the following treatments:
3. Participants with other malignant tumor within the past 5 years, other than the tumor treated in this study, with the exception of locally cured tumors .
4. Participants with related AEs (except for alopecia and ≤ Grade 2 sensory neuropathy) caused by previous treatment that have not recovered to ≤ Grade 1 or baseline level.
5. Participants with known weight loss of >10% within 2 months before the first dose of the study drug or other indicators showing severe malnutrition.
6. Participants with serious complications or medical histories involving important organs.
7. Participants with known active central nervous system (CNS) metastasis.
8. Participants with any of the cardiovascular/cerebrovascular disorders, symptoms, or manifestations.
9. Participants with the following conditions will be excluded at screening: active syphilis, history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or active hepatitis C virus (HCV), with the exception of asymptomatic chronic hepatitis B or C virus carriers.
10. Participants with a history of interstitial pneumonia or other moderate to severe lung disorders that seriously affect lung function.
11. Participants with severe infection during the screening period.
12. Participants with other diseases that may affect the efficacy and safety of the study drug.
13. Participants with uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically significant moderate or greater ascites during the screening period.
14. Participants with unstable thrombotic events requiring therapeutic intervention within 6 months before screening; however, thrombosis related to infusion devices is not included.
15. Participants who have received a live vaccine within 30 days before the first dose, or plan to receive a live vaccine during the study period.
16. Participants who have received strong CYP3A4 inhibitors and inducers therapy within 1 week before dosing, or are expected to require long-term use of strong CYP3A4 inhibitors and inducers during the study intervention and within 30 days after the last dose .
17. Participants with history of solid organ transplant.
18. Participants with known or suspected history of severe allergy to any component of the study drug or its analogues.
19. Pregnant and lactating women.
20. Participants who are deemed unsuitable for this study (e.g., poor compliance, etc.) by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhou Caicun | Contact | +8613301825532 | caicunzhoudr@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Recruiting | Shanghai | Shanghai Municipality | 200123 | China |
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| Approximately 1year |
| Peak Plasma Concentration (Cmax) of HDM2024 | Cmax of HDM2024, total antibody, and exatecan will be measured | Approximately 1 year |
| Area under the plasma concentration versus time curve (AUC) of HDM2024 | AUC of HDM2024, total antibody, and exatecan will be measured | approximately 1 year |
| Objective response rate (ORR) | ORR assessed based on RECIST v1.1 criterion | Approximately 1 year |
| Disease control rate (DCR) | DCR assessed based on RECIST v1.1 criterion | Approximately 1 year |
| Progression-free survival (PFS) | PFS assessed based on RECIST v1.1 criterion | Approximately 1year |
| Overall survival (OS) | OS of 6-months and 12-months | Approximately 1 year |