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
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
- Not yet 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
- Oct 2026
- First submitted
- 30 Apr 2024
- Last updated
- 7 Oct 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