DCSZ11 in Combination With Standard Therapy in Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest China Hospital
About this trial
To evaluate the safety and efficacy of DCSZ11 in combination with standard therapy in patients with advanced or metastatic solid tumors.
Eligibility criteria
Qualifiers
Male or female patients aged ≥18 years.
Willing and able to provide written informed consent for the study.
Patients with histologically confirmed advanced or metastatic solid tumors. Note: Patients must have guideline-eligible standard chemotherapy and immunotherapy options available.Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) must have PD-L1 Combined Positive Score (CPS) ≥1.Lung cancer patients with known actionable driver gene mutations/genomic aberrations (e.g., EGFR sensitizing mutations, BRAF V600E mutation, ROS1 rearrangements, NTRK gene fusions, ALK rearrangements) are excluded.Prior adjuvant or neoadjuvant chemotherapy is permitted, provided ≥6 months have elapsed between the last dose of chemotherapy/immunotherapy and documented recurrent disease.Gastric cancer patients must be HER2-negative.
Patients must have at least one measurable lesion per RECIST 1.1 criteria. Lesions located in previously irradiated areas may be considered measurable if there is objective evidence of progression in those lesions prior to study enrollment.
Disqualifiers
Systemic anticancer therapy or investigational products within 6 months prior to first study dose.
Extensive radiotherapy (RT) ≤6 months prior to treatment initiation (*≤7 days for palliative local RT outside chest/brain*) OR unresolved RT-related toxicity requiring corticosteroids.
Known active CNS metastases and/or carcinomatous meningitis.
Major surgery within 4 weeks or minor surgery within 2 weeks prior to first dose.
Trial design
Treatments tested in this trial
- Low Dose DCSZ11
- Medium Dose DCSZ11
- High Dose DCSZ11
- Standard Treatment
Treatment groups
9 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov