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A Study of Sofe-M in Participants With Selected Advanced Solid Tumors

ConditionsOvarian NeoplasmsEndometrial NeoplasmsUterine Cervical NeoplasmsCarcinoma, Non-Small-Cell LungTriple Negative Breast NeoplasmsPancreatic NeoplasmColorectal Neoplasms
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, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion). The study will last up to approximately 5 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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, TNBC, and high grade endometrioid cancer

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sofe-M

    Drug

    Intravenous

  • bevacizumab

    Drug

    IV

  • carboplatin

    Drug

    IV

  • Itraconazole

    Drug

    oral

  • pembrolizumab

    Drug

    IV

Treatment groups

575 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: Sofe-M (Dose-escalation, Cohort A1)Experimental treatment 1 intervention
Group B: Sofe-M (Cohort A1 Parts A and C)Experimental treatment 1 intervention
Group C: Sofe-M Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B)Experimental treatment 2 interventions
Group D: Sofe-M (Dose-optimization, Cohort A2)Experimental treatment 1 intervention
Group E: Sofe-M (Enrichment Cohort A3)Experimental treatment 1 intervention
Group F: Sofe-M (Combination Cohort A4)Experimental treatment 2 interventions
Group G: Sofe-M (Combination Cohort A5)Experimental treatment 2 interventions
Group H: Sofe-M Combination with Pembrolizumab (Dose-optimization Cohort A6)Experimental treatment 2 interventions
Group I: Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7)Experimental treatment 3 interventions
Group J: Sofe-M (Dose-expansion, Cohort B2-B4)Experimental treatment 1 intervention
Group K: Sofe-M (Dose-expansion, Cohort B1)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1a: To determine the recommended phase 2 dose (RP2D) of Sofe-M (LY4170156)

Number of participants with dose-limiting toxicities (DLTs)

Time frame
1 Cycle (21 or 28 days)
2

Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with bevacizumab

Number of participants with DLTs

Time frame
1 Cycle (21 or 28 days)
3

Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with carboplatin

Number of participants with DLTs

Time frame
1 Cycle (21 or 28 days)
4

Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with pembrolizumab

Number of participants with DLTs

Time frame
1 Cycle (21 or 28 days)

Secondary outcomes

1

To characterize the pharmacokinetics (PK) properties of Sofe-M (LY4170156): Minimum Plasma Concentration (Cmin)

PK: Cmin of Sofe-M (LY4170156)

Time frame
First 4 Cycles (84 days)
2

To characterize the PK properties of Sofe-M (LY4170156): Cmin with bevacizumab or carboplatin

PK: Cmin of Sofe-M (LY4170156)

Time frame
First 4 Cycles (Approximately 84 days)
3

To characterize the PK properties of Sofe-M (LY4170156): Cmin with pembrolizumab

PK: Cmin of Sofe-M (LY4170156)

Time frame
First 4 Cycles (84 days)
4

To characterize the PK properties of Sofe-M (LY4170156): Area under the concentration versus time curve (AUC)

PK: AUC of Sofe-M (LY4170156)

Time frame
First 4 Cycles (84 days)

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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