GDC-1971
DrugCapsule or tablet administered orally.
Other names: RO7517834, RLY-1971
NCT Number: NCT05487235
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of GDC-1971 when administered in combination with atezolizumab in participants with locally advanced or metastatic solid tumors.
The study will have 2 stages- dose finding stage and expansion stage. In expansion stage participants with non-small cell lung cancer programmed death ligand -1 high (NSCLC PD L-1 high), NSCLC PD L-1 low, head and neck squamous cell carcinoma (HNSCC) PD L-1 positive, BRAF wild type (BRAF WT) melanoma and any locally advanced or metastatic solid tumors will be enrolled.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Sanatorio Allende, Córdoba, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for Dose-Finding Stage:
Inclusion criteria
for Expansion Stage: NSCLC Cohort
Inclusion criteria
for Expansion Stage: HNSCC Cohort
Inclusion criteria
for Expansion Stage: BRAF WT melanoma Cohort
Inclusion criteria
for Expansion Stage: Other Advanced or Metastatic Solid Tumors Cohort
Exclusion criteria
Capsule or tablet administered orally.
Other names: RO7517834, RLY-1971
Administered as IV infusion.
Other names: RO5541267
Administered orally as tablet or capsule in the acid-reducing agent assessment.
Time frame: Up to approximately 2.5 years
Time frame: Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)
Time frame: Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)
Time frame: Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)
Time frame: From Day 1 to Day 21 of Cycle 1 of the dose finding stage
Time frame: Up to approximately 2.5 years
Time frame: Up to approximately 2.5 years
Time frame: Up to approximately 2.5 years
Time frame: Up to approximately 2.5 years
Time frame: Up to approximately 2.5 years
Time frame: Up to approximately 2.5 years
Time frame: Up to approximately 2.5 years
Time frame: Up to approximately 2.5 years
Time frame: Up to approximately 2.5 years
Time frame: Up to approximately 2.5 years
Time frame: Up to approximately 2.5 years
Time frame: Up to approximately 2.5 years
Time frame: Month 6
Time frame: Months 6 and 12
Genentech, Inc.
Industry
A Phase Ib, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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