jRCT2031250706
Not yet recruiting
Not Applicable
AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 IN COMBINATION WITH DIFFERENT ANTICANCER AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Not provided0 sites162 target enrollmentStarted: TBD
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 162
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy
- •PD-L1 status available
- •Part B only: PD-L1 >= TPS 1%
- •Measurable disease based on RECIST v1.1 per investigator.
- •Eastern Cooperative Oncology Group performance status of 0 or
- •Adequate organ function
Exclusion Criteria
- •Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET
- •History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
- •Known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
- •Leptomeningeal disease
- •Active autoimmune diseases requiring systemic treatment within the past 2 years
- •Previous systemic anti-tumor therapy for locally advanced, unresectable, or metastatic NSCLC
- •Previous treatment with immunotherapy (exception is (neo)adjuvant anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy to the lung within 6 months of first dose of study intervention
Investigators
Similar Trials
Not yet recruiting
Not Applicable
A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer*Urothelial Cancer
*Advanced/Metastatic Urothelial Cancer
*Urothelial CarcinomajRCT2021250056132
Not yet recruiting
Phase 1
A Phase I Interventional Open-Label, Non-Randomized Dose-Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Anti-Tumor Activity of Autologous p95HER2.CAR-TECH2Me T Cells in Patients with Selected Advanced Cancers. Catherine Trial2024-516660-28-01Vall D Hebron Institute Of Oncology15
Recruiting
Not Applicable
Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia (SHASTA-10) (SHASTA-10 Study)HypertriglyceridemiajRCT20312506333
Completed
Phase 1
A Phase I, Open-Label Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose2022-500921-34-00Achieve Life Sciences Inc.56
Recruiting
Phase 1
A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects with Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - The ONKORAS-101 Study2024-512515-45-01Theras Inc.45