Clinical trial NCT06400472: A Study of LY4170156 in Participants With Selected Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Ovarian Neoplasms
Endometrial Neoplasms
Uterine Cervical Neoplasms
Carcinoma, Non-Small-Cell Lung
Triple Negative Breast Neoplasms
Pancreatic Neoplasm
Colorectal Neoplasms
Keywords: Folate receptor alpha
NSCLC
Ovarian cancer
Cervical cancer
Endometrial cancer
Solid tumor
Lung cancer
Breast cancer
Pancreatic cancer
Colorectal cancer
Anti-drug conjugate
Phase I
Chemotherapy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-05-06
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Have one of the following solid tumor cancers:

  * Cohort A1: 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, and colorectal cancer (CRC)
  * Cohort A2/A3/A4/A5/B1/B2: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer
  * Cohort C1/C2: Endometrial cancer, cervical cancer, NSCLC, TNBC, CRC or pancreatic cancer

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

Primary outcomes:
measure: Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156
timeFrame: 1 Cycle (21 days)
measure: Phase 1a: To determine the RP2D or optimal dose of LY4170156 with bevacizumab
timeFrame: 1 Cycle (21 days)
measure: Phase 1a: To determine the RP2D or optimal dose of LY4170156 with carboplatin
timeFrame: 1 Cycle (21 days)
measure: Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR)
timeFrame: Up to Approximately 48 Months or 4 Years
Secondary outcomes:
measure: To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin)
timeFrame: First 4 Cycles (84 days)
measure: To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin) with vevacizumab or carboplatin
timeFrame: First 4 Cycles (84 days)
measure: To characterize the PK properties of LY4170156: Area under the concentration versus time curve (AUC)
timeFrame: First 4 Cycles (84 days)
measure: To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR)
timeFrame: Up to Approximately 48 Months or 4 Years
measure: To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR) with bevacizumab or carboplatin
timeFrame: Up to Approximately 48 Months or 4 Years
measure: To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR)
timeFrame: Up to Approximately 48 Months or 4 Years
measure: To evaluate the preliminary antitumor activity of LY4170156: Duration of response (DOR) with bevacizumab or carboplatin
timeFrame: Up to Approximately 48 Months or 4 Years]
measure: To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR)
timeFrame: Up to Approximately 48 Months or 4 Years
measure: To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR) with bevacizumab or carboplatin
timeFrame: Up to Approximately 48 Months or 4 Years]
measure: To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS)
timeFrame: Up to Approximately 48 Months or 4 Years
measure: To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS) with bevacizumab or carboplatin
timeFrame: Up to Approximately 48 Months or 4 Years]
measure: To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR)
timeFrame: Up to Approximately 48 Months or 4 Years
measure: To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR) with bevacizumab or carboplatin
timeFrame: Up to Approximately 48 Months or 4 Years]
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health Research Institute
state: Arizona
city: Grand Rapids
country: United States
facility: South Texas Accelerated Research Therapeutics (START)
state: Michigan
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: West Valley City
country: United States
facility: START Mountain Region
state: Utah
city: South Brisbane
country: Australia
facility: Icon Cancer Centre South Brisbane Loc. 10
state: Queensland
city: Adelaide
country: Australia
facility: Cancer Research SA
state: South Australia
city: Lyon
country: France
facility: Centre Leon Berard
state: Rhône
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: