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A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

ConditionsMetastatic Solid TumorRecurrent Solid TumorAdvanced Solid TumorUrinary Bladder NeoplasmTriple Negative Breast CancerNon-small Cell Lung CancerEsophageal CancerPancreatic CancerOvarian CancerCervical CancerHead and Neck Squamous Cell CarcinomaProstate CancerRenal Pelvis CancerBladder Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. 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

This trial does not accept healthy volunteers

Qualifiers

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 C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer

Cohort A1/C: 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

Disqualifiers

Individual with known or suspected uncontrolled CNS metastases

Individual with uncontrolled hypercalcemia

Individual with uncontrolled diabetes

Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4052031

    Drug

    Intravenous

Treatment groups

420 Participants
are divided into 3 treatment groups
Group A: LY4052031 (Dose-escalation, Cohort A1)Experimental treatment 1 intervention
Group B: LY4052031 (Dose-optimization, Cohort A2)Experimental treatment 1 intervention
Group C: LY4052031 (Dose-expansion, Cohort B1, B2, C1)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031

Number of participants with dose-limiting toxicities (DLTs)

Time frame
Cycle 1 (21 Days)
2

Phase 1b: To assess the antitumor activity of LY4052031 Monotherapy: Overall response rate (ORR)

ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

Time frame
Up to Approximately 48 Months or 4 Years

Secondary outcomes

1

To characterize the pharmacokinetics (PK) properties of LY4052031: Minimum Plasma Concentration (Cmin)

PK: Cmin of LY4052031

Time frame
Cycle 1 (21 Days)
2

To characterize the PK properties of LY4052031: Area under the concentration versus time curve (AUC)

PK: AUC of LY4052031

Time frame
Cycle 1 (21 Days)
3

To evaluate the preliminary antitumor activity of LY4052031: Overall response rate (ORR)

ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1))

Time frame
Up to Approximately 48 Months or 4 Years
4

To evaluate the preliminary antitumor activity of LY4052031: Duration of response (DOR)

DOR per investigator assessed RECIST 1.1

Time frame
Up to Approximately 48 Months or 4 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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