A Phase I/â…¡ Human Study of HY0001a for Injection in Adult Participants With Advanced Solid Tumors (NCT07069062) | Clinical Trial Compass
RecruitingPhase 1/2
A Phase I/â…¡ Human Study of HY0001a for Injection in Adult Participants With Advanced Solid Tumors
China261 participantsStarted 2025-07-21
Plain-language summary
This is a multicenter, open-label, phase I/â…¡ study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic(PD) characteristics of HY0001a for injection in participants with advanced solid tumors.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Voluntarily sign an informed consent form, understand the study and be willing and able to follow and complete all trial procedures;
* ≥18 years old and ≤75 years old, gender: male or female;
* Patients have histological or cytological diagnosis with advanced solid tumors, cann't benefit from existing standard treatment options;The solid tumors included in the dose-expansion phase are as follows: Cohort 1: Esophageal cancer (patients who have previously received at least two lines of standard therapy);Cohort 2: Non-small cell lung cancer (patients who have previously received at least two lines of standard therapy);Cohort 3: Other tumors, such as cervical cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, breast cancer, etc. (patients who have failed or are intolerant to standard therapy).
* In the dose-escalation phase, patients must have evaluable tumor lesions; in the dose-expansion phase, patients must have at least one measurable tumor lesion (according to RECIST 1.1 version);
* In the dose-escalation phase, enrollment does not require the expression of CDCP1 (CUB domain containing protein 1). In the dose-expansion phase, enrollment is required to be positive for CDCP1
* Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;
* Life expectancy ≥3 months;
* Participant must have adequate main organ function;
* Fertile female patients must ha…
What they're measuring
1
Dose Escalation (Part One): Incidence and Nature of Dose-Limiting Toxicity (DLT)