Advanced Solid Tumors
Conditions
Interventions
Treatment:Drug: HDM2024
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participants who voluntarily participate in this study and sign the written Informed Consent Form (ICF) after being fully informed. 2. Male or female participants aged 18 to 75 years (inclusive). 3. Participants with histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors who have experienced disease progression on or after standard therapy, or are intolerant to standard therapy, or for whom no effective standard of care is available. 4. Participants who are able to provide fresh or archival tumor tissue during the screening period. Tumor tissue will be collected for biomarker testing at a central laboratory, including immunohistochemistry for EGFR and HER3. 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 6. Life expectancy >=3 months. 7. According to RECIST v1.1, the participant must have at least one measurable lesion. 8. Participants with good organ function as demonstrated by screening laboratory test results. 9. The fertile participants agreed to take effective contraceptive measures during the study and after its conclusion; and must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before dosing. 10. Participants should be willing and able to complete regular visits, treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects who have received prior treatment with ADCs containing ecitecan (excluding its derivatives) or ADC drugs targeting EGFR and/or HER3. 2. Subjects who have received the following treatments: (1) Subject has had major surgery (excluding minor surgery such as appendectomy and tumor biopsy) within 4 weeks prior to the first dose; (2) Subject has received radiotherapy involving bone marrow (equivalent to pelvic bone marrow area) or large-area radiotherapy within 4 weeks prior to the first dose; or received local radiotherapy (such as thoracic spine, rib radiotherapy) within 2 weeks before the first dose; (3) Subject is on ongoing treatment with systemic corticosteroids (> 10 mg/day of prednisone or equivalent); If the dose of systemic corticosteroids has been stable for 4 weeks, low-dose corticosteroids (eg, 2 months (considering the impact of large changes in thoracic ascites) or other indicators indicative of severe malnutrition within 2 months prior to the first study drug administration. 6. Gastrointestinal perforation, abdominal fistula or extensive bowel resection (including partial colon resection or extensive small bowel resection) within 6 months before the first dose; Presence of complete or incomplete gastrointestinal obstruction (except gastric obstruction correctable by gastric/jejunal feeding tube) or intra-abdominal abscess within 3 months prior to the first dose. 7. History of gastrointestinal bleeding within 3 months before the first dose, or with a clear tendency to gastrointestinal bleeding (including severe esophageal-fundic varices with bleeding risk, local active gastrointestinal ulcer lesions, and persistent positive fecal occult blood; If fecal occult blood is positive during the baseline period, it can be re-examined, and if it is still positive after re-examination, gastroduodenoscopy is required, and if the endoscopy suggests severe esophageal-fundic varices or the investigator judges that there is a clear risk of bleeding, it cannot be enrolled). 8. Subjects with known active CNS metastases. Subjects with brain metastases who have not been treated but are asymptomatic, or whose imaging shows no progression of the disease for at least 4 weeks after treatment, and does not require steroids or antiepileptic drugs for at least 2 weeks, can be considered for enrollment. Subjects with meningeal metastases, regardless of symptomatic conditions, should be excluded. 9. Subjects with any of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity, DLT;Adverse Event (AE) and Serious Adverse Event (SAE);Maximum Tolerated Dose (MTD);Recommended Phase II Clinical Trial Dose (RP2D);Disease-free Survival, DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) characteristics;Objective response rate, ORR;Disease control rate, DCR;Clinical benefit rate, CBR; | — |
Countries
China
Contacts
Public ContactCaicun Zhou
Shanghai East Hospital
Outcome results
None listed