OncoMatch/Clinical Trials/NCT07035249
DCSZ11 in Combination With Standard Therapy in Advanced or Metastatic Solid Tumors
Is NCT07035249 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including Low Dose DCSZ11 and Medium Dose DCSZ11 for dcsz11.
Treatment: Low Dose DCSZ11 · Medium Dose DCSZ11 · High Dose DCSZ11 · Standard Treatment — To evaluate the safety and efficacy of DCSZ11 in combination with standard therapy in patients with advanced or metastatic solid tumors.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) Combined Positive Score (CPS) ≥1 (CPS ≥1)
Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) must have PD-L1 Combined Positive Score (CPS) ≥1.
Required: HER2 (ERBB2) negative
Gastric cancer patients must be HER2-negative.
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
PD-L1 status must be available for all patients via approved immunohistochemistry assay.
Excluded: EGFR sensitizing mutation
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.
Excluded: BRAF V600E mutation
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.
Excluded: ROS1 rearrangement
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.
Excluded: NTRK1 fusion
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.
Excluded: NTRK2 fusion
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.
Excluded: NTRK3 fusion
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.
Excluded: ALK rearrangement
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.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anticancer therapy
Exception: Low-dose corticosteroids (oral prednisolone ≤10 mg daily or equivalent) and therapy with bisphosphonates or RANK ligand (RANKL) inhibitors are permitted.
Systemic anticancer therapy or investigational products within 6 months prior to first study dose.
Cannot have received: extensive radiotherapy
Exception: ≤7 days for palliative local RT outside chest/brain
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.
Lab requirements
Blood counts
ANC ≥1,500/µL; Hemoglobin ≥9 g/dL (without erythropoietin dependency and without pRBC transfusion within preceding 2 weeks); Platelet count ≥100,000/µL.
Kidney function
Estimated creatinine clearance ≥30 mL/min (per Cockcroft-Gault formula).
Liver function
Total serum bilirubin ≤1.5 × ULN; or direct bilirubin ≤ULN for patients with total bilirubin >1.5 × ULN. AST and ALT ≤2.5 × ULN (≤5 × ULN if liver metastases present).
Adequate organ function and bone marrow reserve per laboratory assessments within 10 days prior to first study drug administration.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07035249 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anticancer therapy, extensive radiotherapy disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 Combined Positive Score (CPS) ≥1 is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 any tested is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR sensitizing mutation is an exclusion criterion.
Are patients with BRAF alterations eligible?
No. BRAF V600E mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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