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A Study of LY4175408 in Participants With Advanced Cancer

ConditionsCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaEndometrial NeoplasmsNeoplasm MetastasisTriple Negative Breast 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 measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this study will evaluate how much LY4175408 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. Participation could last up to 4 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Non-small cell lung cancer (NSCLC)

Small cell lung cancer (SCLC)

Endometrial cancer

Triple negative breast cancer (TNBC) (characterized by HR-negative disease and HER2-negative expression according to American Society of Clinical Oncology (ASCO) - College of American Pathologists guidelines).

Disqualifiers

Prior treatment with a protein tyrosine kinase 7 (PTK7) antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as payload (prior therapy with a PTK7 ADC with a non-topoisomerase I inhibitor payload OR non-PTK7 ADC with any payload is permitted). Prior topoisomerase I-based ADCs are not allowed in cohorts A2, B1 or B2.

Any serious unresolved toxicities from prior therapy.

Individual with known or suspected history of uncontrolled central nervous system (CNS) metastases.

Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.

Trial design

Design model

Sequential

Treatments tested in this trial

  • LY4175408

    Drug

    IV infusion

  • Pembrolizumab

    Drug

    IV infusion

  • Carboplatin

    Drug

    IV infusion

  • Cisplatin

    Drug

    IV infusion

Treatment groups

240 Participants
are divided into 5 treatment groups
Group A: Phase 1a Dose Escalation (Cohort A1)Experimental treatment 1 intervention
Group B: Phase 1a Dose Optimization (Cohort A2)Experimental treatment 1 intervention
Group C: Phase 1b Dose Expansion (Cohort B1)Experimental treatment 2 interventions
Group D: Phase 1b Dose Expansion (Cohort B2)Experimental treatment 4 interventions
Group E: Phase 1b Dose Expansion (Cohorts C1, C2 and C3)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1a-Number of Participants with Dose Limiting Toxicities of LY4175408

Time frame
1 Cycle (21 days)
2

Phase 1b-Overall Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)

Per investigator assessed Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

Time frame
Baseline up to approximately 4 years

Secondary outcomes

1

Phase 1a and 1b-Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of LY4175408 (total antibody, conjugated antibody, free payload)

Time frame
First 4 cycles (84 days)
2

Phase 1a and 1b-PK: Area under the Concentration versus Time Curve (AUC) of LY4175408 (total antibody, conjugated antibody, free payload)

Time frame
First 4 cycles (84 days)
3

Phase 1a-ORR: Percentage of Participants with Best Response of CR or PR

Per investigator assessed RECIST 1.1

Time frame
Baseline up to approximately 4 years
4

Phase 1a and 1b-Time to Response (TTR)

Per investigator assessed RECIST 1.1

Time frame
Baseline up to approximately 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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