Ovarian NeoplasmsPhase 1NCT06400472
A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
A Phase 1 study testing Sofe-M, bevacizumab and carboplatin in people with Ovarian Neoplasms and Endometrial Neoplasms, run by Eli Lilly and Company at 25 sites in 7 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms
- What is being tested?
- Sofe-M, bevacizumab and carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 575 participants
- Where
- 25 sitesin 7 countries
- Study dates
- 20 May 2024to Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have one of the following solid tumor cancers:
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
25 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
25 sites in 7 countries
United States11 sites, 11 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30308
Beryl Manning-Geist
- Recruiting
The Ohio State University (OSU) Wexner Medical Center
Columbus, Ohio, 43210
David O'Malley
- Not yet recruiting
Inova Schar Cancer Institute
Falls Church, Virginia, 22042
Leslie Randall
- Recruiting
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, 49546
616-389-1652
Nehal Lakhani
- Recruiting
The University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4000
Shannon Westin
- Recruiting
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, 92037
858-657-7000
Ramez Eskander
- Recruiting
NYU Langone Health - Long Island
Mineola, New York, 11501
Bhavana Pothuri
- Recruiting
New York University (NYU) Clinical Cancer Center
New York, New York, 10016
212-731-5100
Bhavana Pothuri
- Recruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Chrisann Kyi
- Recruiting
HonorHealth
Scottsdale, Arizona, 85258
480-323-1350
Muhammad Khawaja
- Recruiting
START Mountain Region
West Valley City, Utah, 84119
William McKean
France3 sites, 3 recruiting
- Recruiting
Centre Leon Berard
Lyon, 69373
+33478782644
Isabelle Ray-Coquard
- Recruiting
Institut de Cancerologie de l'Ouest - site St-Herblain
Saint-Herblain, 44805
+33 02 40 67 99 00
Mario Campone
- Recruiting
Oncopole Claudius Regaud
Toulouse, 31059
Carlos Gomez-Roca
Japan3 sites, 3 recruiting
- Recruiting
Shizuoka Cancer Center
Shizuoka, 411-8777
81120023812
Haruyasu Murakami
- Recruiting
National Cancer Center Hospital
Tokyo, 104-0045
81120023812
Takafumi Koyama
- Recruiting
Cancer Institute Hospital of JFCR
Tokyo, 135-8550
81120023812
Shigehisa Kitano
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
+34 932543450
Roberta Mazzeo
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
+34 913908922
Ainhoa Madariaga Urrutia
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
+34 961973527
Jose Alejandro Perez Fidalgo
Australia2 sites, 2 recruiting
- Recruiting
Cancer Research SA
Adelaide, 5000
Meena Okera
- Recruiting
Icon Cancer Centre South Brisbane
QLD, 4101
Jermaine Coward
Italy2 sites, 2 recruiting
- Recruiting
Humanitas San Pio X
Milan, 20159
Domenica Lorusso
- Recruiting
Istituto Europeo di Oncologia
Milan, 20141
+39 02 5748 9599
Giuseppe Curigliano
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si Gyeonggi-do, 10408
82-1588-8110
Myong Cheol Lim
About this study
Official title: A First-in-Human, Phase 1/2 Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Sofetabart Mipitecan (LY4170156), an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors
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.
- Conditions
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Pancreatic Neoplasm
- Being tested
- Sofe-M, bevacizumab, carboplatin, Itraconazole, pembrolizumab
- 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, sofe-m
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofe-MDrug
Also called sofetabart mipitecan, LY4170156
Intravenous
bevacizumabDrug
IV
carboplatinDrug
IV
ItraconazoleDrug
oral
pembrolizumabDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| Sofe-M (Dose-escalation, Cohort A1) | Experimental | Escalating doses of Sofe-M administered intravenously (IV) Receives: Drug: Sofe-M |
| Sofe-M (Cohort A1 Parts A and C) | Experimental | Sofe-M administered IV Receives: Drug: Sofe-M |
| Sofe-M Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B) | Experimental | Sofe-M administered IV and itraconazole administered orally Receives: Drug: Sofe-M; Drug: Itraconazole |
| Sofe-M (Dose-optimization, Cohort A2) | Experimental | Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV Receives: Drug: Sofe-M |
| Sofe-M (Enrichment Cohort A3) | Experimental | Monotherapy administered IV Receives: Drug: Sofe-M |
| Sofe-M (Combination Cohort A4) | Experimental | Combination with bevacizumab administered IV Receives: Drug: Sofe-M; Drug: bevacizumab |
| Sofe-M (Combination Cohort A5) | Experimental | Combination with carboplatin administered IV Receives: Drug: Sofe-M; Drug: carboplatin |
| Sofe-M Combination with Pembrolizumab (Dose-optimization Cohort A6) | Experimental | Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with pembrolizumab Receives: Drug: Sofe-M; Drug: pembrolizumab |
| Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7) | Experimental | Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with or without bevacizumab Receives: Drug: Sofe-M; Drug: bevacizumab; Drug: carboplatin |
| Sofe-M (Dose-expansion, Cohort B2-B4) | Experimental | Sofe-M administered IV Receives: Drug: Sofe-M |
| Sofe-M (Dose-expansion, Cohort B1) | Experimental | Sofe-M administered IV Receives: Drug: Sofe-M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: To determine the recommended phase 2 dose (RP2D) of Sofe-M (LY4170156)
Number of participants with dose-limiting toxicities (DLTs)
Measured: 1 Cycle (21 or 28 days)
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with bevacizumab
Number of participants with DLTs
Measured: 1 Cycle (21 or 28 days)
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with carboplatin
Number of participants with DLTs
Measured: 1 Cycle (21 or 28 days)
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with pembrolizumab
Number of participants with DLTs
Measured: 1 Cycle (21 or 28 days)
Phase 1b: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: Overall response rate (ORR)
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Measured: Up to Approximately 60 Months or 5 Years
Phase 2: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: ORR
ORR per RECIST 1.1
Measured: Up to Approximately 60 Months or 5 Years
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: Up to Approximately 60 Months or 5 Years
Secondary outcomes (15)
To characterize the pharmacokinetics (PK) properties of Sofe-M (LY4170156): Minimum Plasma Concentration (Cmin)
PK: Cmin of Sofe-M (LY4170156)
Measured: First 4 Cycles (84 days)
To characterize the PK properties of Sofe-M (LY4170156): Cmin with bevacizumab or carboplatin
PK: Cmin of Sofe-M (LY4170156)
Measured: First 4 Cycles (Approximately 84 days)
To characterize the PK properties of Sofe-M (LY4170156): Cmin with pembrolizumab
PK: Cmin of Sofe-M (LY4170156)
Measured: First 4 Cycles (84 days)
To characterize the PK properties of Sofe-M (LY4170156): Area under the concentration versus time curve (AUC)
PK: AUC of Sofe-M (LY4170156)
Measured: First 4 Cycles (84 days)
To characterize the patient-reported outcomes (PRO) Common Terminology Criteria for Adverse Events (CTCAE) of Sofe-M (LY4170156)
PRO-CTCAE of Sofe-M (LY4170156)
Measured: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Overall response rate (ORR)
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Measured: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Overall response rate (ORR) with bevacizumab or carboplatin or pembrolizumab
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Measured: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Duration of response (DOR)
DOR per investigator assessed RECIST 1.1
Measured: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Duration of response (DOR) with bevacizumab or carboplatin or pembrolizumab
DOR per investigator assessed RECIST 1.1
Measured: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Time to response (TTR)
TTR per investigator assessed RECIST 1.1
Measured: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Time to response (TTR) with bevacizumab or carboplatin or pembrolizumab
TTR per investigator assessed RECIST 1.1
Measured: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Progression free survival (PFS)
PFS per investigator assessed RECIST 1.1
Measured: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Progression free survival (PFS) with bevacizumab or carboplatin or pembrolizumab
PFS per investigator assessed RECIST 1.1
Measured: Up to Approximately 60 Months or 5 Years]
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Disease control rate (DCR)
DCR per investigator assessed RECIST 1.1
Measured: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Disease control rate (DCR) with bevacizumab or carboplatin or pembrolizumab
DCR per investigator assessed RECIST 1.1
Measured: Up to Approximately 60 Months or 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start20 May 2024
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 575 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400472
- Sponsor's protocol ID
- 18863
- Other IDs
- 2024-511238-11-00, J5E-OX-JZXA, LOXO-FRA-24001
- Status last verified
- Nov 2026
- First submitted
- 30 Apr 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Ray-Coquard I, O'Malley DM, Oaknin A, Madariaga A, Lakhani N, McKean W, Perez-Fidalgo A, Okera M, Kitano S, Koyama T, Frenel JS, Curigliano G, Khajawa MR, Cheol Lim M, Lorusso D, Pilla Reddy V, Speck RM, Gilligan AM, Szpurka AM, Manvelyan M, Wu Y, Wang C, Avsar E, Friedman CF, Sachdeva D, Kyi C, Pothuri B. Sofetabart mipitecan, an antibody drug conjugate targeting folate receptor alpha, in high grade ovarian cancer: Results from the first-in-human phase 1 study. Ann Oncol. 2026 Oct 8:S0923-7534(26)06781-5. doi: 10.1016/j.annonc.2026.10.001. Online ahead of print.
PubMed 42849725
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Phase 1/2 Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Sofetabart Mipitecan (LY4170156), an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06400472
- Acronym / sponsor ID
- 18863
- Conditions
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Pancreatic Neoplasm
- Keywords
- Folate receptor alpha, NSCLC, Ovarian cancer, Cervical cancer, Endometrial cancer, Solid tumor, Lung cancer, Breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 575 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Sofe-M (Dose-escalation, Cohort A1) | Experimental | Drug: Sofe-MEscalating doses of Sofe-M administered intravenously (IV) |
| Sofe-M (Cohort A1 Parts A and C) | Experimental | Drug: Sofe-MSofe-M administered IV |
| Sofe-M Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B) | Experimental | Drug: Sofe-M, Drug: ItraconazoleSofe-M administered IV and itraconazole administered orally |
| Sofe-M (Dose-optimization, Cohort A2) | Experimental | Drug: Sofe-MComparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV |
| Sofe-M (Enrichment Cohort A3) | Experimental | Drug: Sofe-MMonotherapy administered IV |
| Sofe-M (Combination Cohort A4) | Experimental | Drug: Sofe-M, Drug: bevacizumabCombination with bevacizumab administered IV |
| Sofe-M (Combination Cohort A5) | Experimental | Drug: Sofe-M, Drug: carboplatinCombination with carboplatin administered IV |
| Sofe-M Combination with Pembrolizumab (Dose-optimization Cohort A6) | Experimental | Drug: Sofe-M, Drug: pembrolizumabComparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with pembrolizumab |
| Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7) | Experimental | Drug: Sofe-M, Drug: bevacizumab, Drug: carboplatinComparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with or without bevacizumab |
| Sofe-M (Dose-expansion, Cohort B2-B4) | Experimental | Drug: Sofe-MSofe-M administered IV |
| Sofe-M (Dose-expansion, Cohort B1) | Experimental | Drug: Sofe-MSofe-M administered IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have one of the following solid tumor cancers:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofe-MAlso: sofetabart mipitecan, LY4170156Intravenous | Drug | Sofe-M (Cohort A1 Parts A and C), Sofe-M (Combination Cohort A4), Sofe-M (Combination Cohort A5), Sofe-M (Dose-escalation, Cohort A1), Sofe-M (Dose-expansion, Cohort B1), Sofe-M (Dose-expansion, Cohort B2-B4), Sofe-M (Dose-optimization, Cohort A2), Sofe-M (Enrichment Cohort A3), Sofe-M Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B), Sofe-M Combination with Pembrolizumab (Dose-optimization Cohort A6), Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7) |
| bevacizumabIV | Drug | Sofe-M (Combination Cohort A4), Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7) |
| carboplatinIV | Drug | Sofe-M (Combination Cohort A5), Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7) |
| Itraconazoleoral | Drug | Sofe-M Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B) |
| pembrolizumabIV | Drug | Sofe-M Combination with Pembrolizumab (Dose-optimization Cohort A6) |
Primary outcome
Phase 1a: To determine the recommended phase 2 dose (RP2D) of Sofe-M (LY4170156)
Time frame: 1 Cycle (21 or 28 days)
Number of participants with dose-limiting toxicities (DLTs)
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with bevacizumab
Time frame: 1 Cycle (21 or 28 days)
Number of participants with DLTs
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with carboplatin
Time frame: 1 Cycle (21 or 28 days)
Number of participants with DLTs
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with pembrolizumab
Time frame: 1 Cycle (21 or 28 days)
Number of participants with DLTs
Phase 1b: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: Overall response rate (ORR)
Time frame: Up to Approximately 60 Months or 5 Years
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Phase 2: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: ORR
Time frame: Up to Approximately 60 Months or 5 Years
ORR per RECIST 1.1
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Up to Approximately 60 Months or 5 Years
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
15 secondary outcomes
To characterize the pharmacokinetics (PK) properties of Sofe-M (LY4170156): Minimum Plasma Concentration (Cmin)
Time frame: First 4 Cycles (84 days)
To characterize the PK properties of Sofe-M (LY4170156): Cmin with bevacizumab or carboplatin
Time frame: First 4 Cycles (Approximately 84 days)
To characterize the PK properties of Sofe-M (LY4170156): Cmin with pembrolizumab
Time frame: First 4 Cycles (84 days)
To characterize the PK properties of Sofe-M (LY4170156): Area under the concentration versus time curve (AUC)
Time frame: First 4 Cycles (84 days)
To characterize the patient-reported outcomes (PRO) Common Terminology Criteria for Adverse Events (CTCAE) of Sofe-M (LY4170156)
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Overall response rate (ORR)
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Overall response rate (ORR) with bevacizumab or carboplatin or pembrolizumab
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Duration of response (DOR)
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Duration of response (DOR) with bevacizumab or carboplatin or pembrolizumab
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Time to response (TTR)
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Time to response (TTR) with bevacizumab or carboplatin or pembrolizumab
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Progression free survival (PFS)
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Progression free survival (PFS) with bevacizumab or carboplatin or pembrolizumab
Time frame: Up to Approximately 60 Months or 5 Years]
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Disease control rate (DCR)
Time frame: Up to Approximately 60 Months or 5 Years
To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Disease control rate (DCR) with bevacizumab or carboplatin or pembrolizumab
Time frame: Up to Approximately 60 Months or 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Derived from this study: PubMed 42849725Ray-Coquard I, O'Malley DM, Oaknin A, Madariaga A, Lakhani N, McKean W, Perez-Fidalgo A, Okera M, Kitano S, Koyama T, Frenel JS, Curigliano G, Khajawa MR, Cheol Lim M, Lorusso D, Pilla Reddy V, Speck RM, Gilligan AM, Szpurka AM, Manvelyan M, Wu Y, Wang C, Avsar E, Friedman CF, Sachdeva D, Kyi C, Pothuri B. Sofetabart mipitecan, an antibody drug conjugate targeting folate receptor alpha, in high grade ovarian cancer: Results from the first-in-human phase 1 study. Ann Oncol. 2026 Oct 8:S0923-7534(26)06781-5. doi: 10.1016/j.annonc.2026.10.001. Online ahead of print.
- A Study of LY4170156 in Participants With Selected Advanced Solid TumorsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
25 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sofe-M, bevacizumab and carboplatin in people with Ovarian Neoplasms and Endometrial Neoplasms, run by Eli Lilly and Company at 25 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, France, Japan, Spain, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: To determine the recommended phase 2 dose (RP2D) of Sofe-M (LY4170156) (time frame: 1 Cycle (21 or 28 days)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06400472, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.