A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small… (NCT06016270) | Clinical Trial Compass
TerminatedPhase 1/2
A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer
Stopped: Company strategy
United States, South Korea10 participantsStarted 2024-02-13
Plain-language summary
The purpose of this clinical study is to assess the safety and efficacy of hSTC810 and paclitaxel combination therapy in patients with relapsed or refractory extensive stage small cell lung cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Ability to understand and sign an informed consent form
* Male or female ≥ 18 years of age
* Histologically or cytologically confirmed SCLC
* R/R ES-SCLC on or after platinum-based chemotherapy for SCLC with documented disease progression
* At least 1 measurable lesion as defined by RECIST 1.1
* Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 or 1
* Life expectancy of at least 3 months
* Adequate organ function as described in the protocol
* For female or male patients with reproductive potential: Agree to use contraception throughout the study and at least 5 months after the last dose.
Exclusion Criteria:
* Known active leptomeningeal disease (carcinomatous meningitis)
* Known active and uncontrolled central nervous system (CNS) metastases
* Treatment with immunotherapy, chemotherapy, targeted small molecule therapy, or any other investigational agent \< 14 days prior to initiation of study treatment
* Treatment with radiation therapy \< 14 days prior to initiation of study treatment
* Major surgery \< 21 days prior to initiation of study treatment
* Received live vaccine \< 30 days prior to initiation of study treatment, including intranasal influenza vaccine
* History of another primary malignancy with protocol-defined exceptions
* Active or history of autoimmune disease requiring systemic treatment
* Receiving high doses of steroids or other immunosuppressive medications
* Active hepatitis B or C infection
* Active or history o…