Clinical trial · Interventional
Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC
Phase 1b Single Arm, Open-label Trial of RYZ101 in Combination With Carboplatin + Etoposide + Atezolizumab in Subjects With Somatostatin Receptor Expressing (SSTR+) Extensive Stage Small Cell Lung Cancer (ES-SCLC)
NCT05595460CI-TRIAL-00108044active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| SCLC,Extensive Stage | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| RYZ101 Dose Level 1 | Drug | — | UNRESOLVED |
| RYZ101 Dose Level 2 | Drug | — | UNRESOLVED |
| RYZ101 Dose Level 3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RYZ101 + SoC
- interventionNames
- Drug: RYZ101 Dose Level 1
- Drug: RYZ101 Dose Level 2
- Drug: RYZ101 Dose Level 3
- Drug: RYZ101 Dose Level -1
- Drug: Atezolizumab
- Drug: Carboplatin
- Drug: Etoposide
Primary outcomes (2)
- measure
- RP2D
- timeFrame
- 42 days of study treatment
- description
- RP2D as determined by incidence rate of DLTs
- measure
- Safety and tolerability of RYZ101 in combination with SoC
- timeFrame
- Up to 50 months
- description
- Safety and tolerability of RYZ101 in combination with SoC as measured by incidence and severity of AEs including SAEs, laboratory changes and other safety findings
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab. * Radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy. Radiation therapy outside of the chest for palliative care is allowed but must be completed \>2 weeks prior to first dose of study drug. * Significant cardiovascular disease and/or resistant hypertension * Subjects with previously treated central nervous system (CNS) metastases who have not recovered from acute side effects of radiotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.