Health TrialsbyHealthPanel

DCSZ11 in Combination With Standard Therapy in Advanced or Metastatic Solid Tumors

ConditionsDCSZ11Solid TumorsHNSCC
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Low Dose DCSZ11

    Drug

    Patients will receive DCSZ11 at 600 mg every three weeks (Q3W).

  • Medium Dose DCSZ11

    Drug

    Patients will receive DCSZ11 at 800 mg Q3W.

  • High Dose DCSZ11

    Drug

    Patients will receive DCSZ11 at 1200 mg Q3W.

  • Standard Treatment

    Drug

    The available standard treatment for head and neck cancer patients.

Treatment groups

9 Participants
are divided into 3 treatment groups
Group A: Low DoseExperimental treatment 2 interventions
Group B: Medium DoseExperimental treatment 2 interventions
Group C: High DoseExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

The ratio of participants assessed with complete response (CR) or partial response(PR) as a best overall response.

Time frame
2 years

Secondary outcomes

1

Disease Control Rate (DCR)

The ratio of subjects assessed with CR or PR or stable disease (SD) as a best overalresponse.

Time frame
2 years
2

DRR (Durable Response Rate)

DRR is defined as the proportion of objective response (CR and PR as determined by the investigator) lasting at least 6 months at any time within 12 months of initiation of treatment.

Time frame
2 years
3

DOR (Duration of Response)

DOR is defined as the time from the date when the PR is first recorded or better to the date when the disease progression is first recorded (for the responder, i.e., PR or better). Responders who did not record disease progress will be censored on the date that the last assessment was SD or better.

Time frame
2 years
4

TTR (Response Time）

TTR is defined as the time from the date of the first administration to the date of the first record of the objective tumor response (CR and PR determined by the investigator).

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov
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