Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC (NCT05595460) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC
United States21 participantsStarted 2022-10-10
Plain-language summary
This study aims to determine the safety, preliminary antitumor activity, and pharmacokinetics (PK) of RYZ101 in combination with standard of care (SoC) therapy consisting of carboplatin + etoposide + atezolizumab in untreated subjects with somatostatin receptor expressing (SSTR+) ES-SCLC.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA
* Age of at least 18 years at the time of signing the informed consent.
* Cytologically or histologically confirmed ES-SCLC (American Joint Committee on Cancer \[AJCC\] 8th edition) and is untreated or received ≤1 cycle of platinum-etoposide and PD-L1 inhibitor therapy. It is acceptable to omit the first dose of PD-L1 inhibitor therapy due to logistical reasons if receiving SoC during or prior to the start of the screening period.
* Subject is a candidate for therapy with SoC which includes:
* Carboplatin for a maximum of 4 cycles
* Etoposide for a maximum of 4 cycles
* Atezolizumab
* At least 1SSTR-PET imaging-positive measurable site of disease (according to RECIST v1.1) and ≥50% of RECIST v1.1 measurable metastatic lesions must be SSTR-imaging positive.
* Adequate hematologic, renal and hepatic function
EXCLUSION CRITERIA
* Prior exposure to immune-mediated therapy,
* Known active or suspected autoimmune disease or any condition requiring systemic treatment with immunosuppressive medications within 14 days prior to first dose of study drug
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis. Note: History of radiation pneumonitis is permitted.
* Severe infection within 4 weeks and/or treatment with therapeutic oral or i.v. antibiotics within 2 weeks prior to initiation of study treatment.
* Prior allogeneic stem cell or solid organ transplantation…
What they're measuring
1
RP2D
Timeframe: 42 days of study treatment
2
Safety and tolerability of RYZ101 in combination with SoC