A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors

JRCT ID: jRCT2031240083

Registered date:14/05/2024

Basic Information

• Recruitment status: Pending

Health condition(s) or Problem(s) studied

Metastatic Solid Tumor
Recurrent Solid Tumor
Advanced Solid Tumor

• Date of first enrollment: 01/06/2024
• Target sample size: 280
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

Drug: LY4101174
Intravenous

[Study Arms]
Experimental: LY4101174 (Dose-escalation, Cohort A1)
Escalating doses of LY4101174 administered intravenously (IV).
Intervention: Drug: LY4101174
Experimental: LY4101174 (Dose-optimization, Cohort A2)
Comparing 2 or more doses (evaluated during dose escalation) of LY4101174 administered IV.
Intervention: Drug: LY4101174
Experimental: LY4101174 (Dose-expansion, Cohort B1, B2, C1-C5))
LY4101174 administered IV.
Intervention: Drug: LY4101174

Outcome(s)

Primary Outcome

Phase 1a: To determine the recommended dose of LY4101174 [ Time Frame: First 2 Cycles (28 days) ]
Number of participants with dose-limiting toxicities (DLTs)
Phase 1a: To determine the recommended phase 2 dose (RP2D) or optimal dose of LY4101174 [ Time Frame: First 2 Cycles (28 days) ]
Number of participants with DLTs
Phase 1b: To assess the antitumor activity of LY4101174 Monotherapy: Overall response rate (ORR) [ Time Frame: Up to Approximately 48 Months or 4 Years ]
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Have one of the following solid tumor cancers:

Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer
Cohort A2/B1/B2: urothelial carcinoma
Cohort C1: triple negative breast cancer
Cohort C2: non-small cell lung cancer
Cohort C3: ovarian or fallopian tube cancer
Cohort C4: cervical cancer
Cohort C5: head and neck squamous cell carcinoma
Prior Systemic Therapy Criteria:

Cohort A1/C1-5: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies
Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.
Prior enfortumab vedotin specific requirements:

Cohorts A1/A2/C1-5: prior treatment with enfortumab vedotin is allowed, but not required
Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting
Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.
Measurability of disease

Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
Cohorts A2, B1, B2, C1-5: measurable disease required as defined by RECIST v1.1

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations

Exclude criteria

Individual with known or suspected uncontrolled CNS metastases
Individual with uncontrolled hypercalcemia
Individual with uncontrolled diabetes
Individual with evidence of corneal keratopathy or history of corneal transplant
Any serious unresolved toxicities from prior therapy
Significant cardiovascular disease
Current of history of intestinal obstruction in the previous 3 months
Recent thromboembolic event or bleeding disorder
Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) >= 470 ms
History of pneumonitis/interstitial lung disease
History of Grade >=3 skin toxicity when receiving enfortumab vedotin
Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT06238479