Recruiting NCT06400472
A Study of LY4170156 in Participants With Selected Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LY4170156, bevacizumab, carboplatin, Itraconazole.
- Who it may be relevant to
- Registry conditions: Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, France, Italy, Japan +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors
Overview
The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.
Interventions
- Drug LY4170156
Intravenous - Drug bevacizumab
IV - Drug carboplatin
IV - Drug Itraconazole
oral - Drug pembrolizumab
IV
Primary outcome measures
- Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156 [Time frame: 1 Cycle (21 days)]
- Phase 1a: To determine the RP2D or optimal dose of LY4170156 with bevacizumab [Time frame: 1 Cycle (21 days)]
- Phase 1a: To determine the RP2D or optimal dose of LY4170156 with carboplatin [Time frame: 1 Cycle (21 days)]
- Phase 1a: To determine the RP2D or optimal dose of LY4170156 with pembrolizumab [Time frame: 1 Cycle (21 days)]
- Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR) [Time frame: Up to Approximately 48 Months or 4 Years]
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Time frame: Up to Approximately 48 Months or 4 Years]
Secondary outcome measures (12)
- To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin) [Time frame: First 4 Cycles (84 days)]
- To characterize the PK properties of LY4170156: Cmin with bevacizumab or carboplatin [Time frame: First 4 Cycles (Approximately 84 days)]
- To characterize the PK properties of LY4170156: Cmin with pembrolizumab [Time frame: First 4 Cycles (84 days)]
- To characterize the PK properties of LY4170156: Area under the concentration versus time curve (AUC) [Time frame: First 4 Cycles (84 days)]
- To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR) [Time frame: Up to Approximately 48 Months or 4 Years]
- To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR) with bevacizumab or carboplatin or pembrolizumab [Time frame: Up to Approximately 48 Months or 4 Years]
- To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR) [Time frame: Up to Approximately 48 Months or 4 Years]
- To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR) with bevacizumab or carboplatin or pembrolizumab [Time frame: Up to Approximately 48 Months or 4 Years]
- To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR) [Time frame: Up to Approximately 48 Months or 4 Years]
- To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR) with bevacizumab or carboplatin or pembrolizumab [Time frame: Up to Approximately 48 Months or 4 Years]
- To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS) [Time frame: Up to Approximately 48 Months or 4 Years]
- To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS) with bevacizumab or carboplatin or pembrolizumab [Time frame: Up to Approximately 48 Months or 4 Years]]
Eligibility criteria
Inclusion criteria
- Have one of the following solid tumor cancers:
- Dose Escalation: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), pancreatic cancer, or colorectal cancer (CRC)
- Dose Optimization: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) and endometrial cancer
- Dose Expansion: Low grade serous ovarian cancer, cervical cancer, NSCLC, and TNBC
Exclusion criteria
- Individual with known or suspected uncontrolled central nervous system (CNS) metastases
- Individual with history of carcinomatous meningitis
- Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Individual with evidence of corneal keratopathy or history of corneal transplant
- Any serious unresolved toxicities from prior therapy
- Significant cardiovascular disease
- Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
- History of pneumonitis/interstitial lung disease
- Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- HonorHealth — Scottsdale
- University of California, San Diego (UCSD) - Moores Cancer Center — La Jolla
- South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids
- NYU Langone Health - Long Island — Mineola
- New York University (NYU) Clinical Cancer Center — New York
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York
- The Ohio State University (OSU) Wexner Medical Center — Columbus
- The University of Texas - MD Anderson Cancer Center — Houston
- … and 1 more center
France · 3 centers
- Centre Leon Berard — Lyon
- Institut de Cancerologie de l'Ouest - site St-Herblain — Saint-Herblain
- Oncopole Claudius Regaud — Toulouse
Japan · 3 centers
- Shizuoka Cancer Center — Shizuoka
- National Cancer Center Hospital — Tokyo
- Cancer Institute Hospital of JFCR — Tokyo
Spain · 3 centers
- Hospital Universitario Vall d'Hebron — Barcelona
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Clinico Universitario de Valencia — Valencia
Australia · 2 centers
- Cancer Research SA — Adelaide
- Icon Cancer Centre South Brisbane — QLD
Italy · 2 centers
- Humanitas San Pio X — Milan
- Istituto Europeo di Oncologia — Milan
South Korea · 1 center
- National Cancer Center — Goyang-si Gyeonggi-do
Identifiers
NCT: NCT06400472 · 18863 · 2024-511238-11-00 · J5E-OX-JZXA · LOXO-FRA-24001