Trial NCT06561685
A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Sponsor
- Eli Lilly and Company
- Conditions
- Metastatic Solid Tumor; Advanced Solid Tumor; Non-small Cell Lung Cancer; SMARCA4-Deficient Tumor
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* Have one of the following locally advanced or metastatic solid tumor malignancy with SMARCA4 (BRG1) alteration:
* Phase 1a dose escalation: Presence of any alteration in SMARCA4 (BRG1)
* Phase 1b expansion: Part A: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.
* Phase 1b expansion: Part B: Any tumor type (other than NSCLC) that has the presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.
* Phase 1b expansion: Part C: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.
* Prior Systemic Therapy Criteria:
* Phase 1a dose escalation and Phase 1b (Part B): Participants who received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating Investigator; or the individual is refusing the remaining most appropriate standard of care treatment; or there is no standard therapy available for the disease.
* Phase 1b expansion (Part A): Participants must have received at least one line of therapy for advanced or metastatic disease.
* Phase 1b expansion (Part C): Participants may be treatment naïve or have received therapy for advanced or metastatic disease
* Measurability of disease
* Phase 1a dose escalation (excluding backfill): measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
* Phase 1a backfill and Phase 1b expansion: Measurable disease required as defined by RECIST v1.1
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1Performance status
Exclusion Criteria:
* Participants with known or likely loss of function alteration of SMARCA2 (BRM) or malignancy with known association with SMARCA2 (BRM) alterations
* Prior exposure to SMARCA2 (BRM) inhibitor(s) and/or degrader(s) (prior exposure may be permitted for dose escalation)
* Participants with known or suspected history of untreated or uncontrolled central nervous system (CNS) involvementBrain metastases
* Participants with history of increased risk of prolonged QT or significant arrythmia
* Significant cardiovascular diseaseCardiac
* Participants with active and/or treated for an additional primary malignancy within 2 years prior to enrolmentPrior malignancy
* Participants who are pregnant, breastfeeding or plan to breastfeed or expecting to conceive or father children during study or within 6 months after the last dose of study interventionPregnancy
* Participants with history of active autoimmune diseases, history of allogenic stem cell/organ transplant or compromised immune system within past 2 years (Part C only)
Restrictions found (5)
- Brain metastasesConditionalexclusionShow in the text
- CardiacConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text - PregnancyOutrightexclusionShow in the text
- Prior malignancyConditionalexclusion
within 2 years
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County
- Dana-Farber Cancer Institute · Boston, Suffolk County