Solid TumorPhase 1NCT03770494

A Study of LY3405105 in Participants With Advanced Cancer

A Phase 1 study testing LY3405105 in people with Solid Tumor, run by Eli Lilly and Company at 17 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The main purpose of this study is to investigate the safety of LY3405105 in participants with advanced cancer. The study has two parts phase 1a and phase 1b. Participants will only enroll in one part. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor
What is being tested?: LY3405105
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 17 sitesin 5 countries
Study dates: 31 Jan 2019to 4 Feb 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Phase 1 a:
Have histological or cytological evidence of a diagnosis of a solid tumor cancer that is advanced and/or metastatic
Have available archived tissue for exploratory biomarker analysis
Have adequate organ function
Have discontinued all previous treatments for cancer and recovered from their side effects
Are able to swallow capsules/tablets

Show all 12Show fewer

Phase 1 b:
Cohort 1: Triple-negative breast cancer (TNBC).
Cohort 2: Clear cell ovarian cancer, endometrioid ovarian cancer, or endometrioid endometrial carcinoma with a LOF mutation in one or more of the following genes: ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX).
Cohort 3: Soft tissue sarcoma or sarcomatoid/rhabdoid malignancy with loss of expression of INI1, BRG1, or BRM by immunohistochemistry or a LOF mutation in one or more of the following genes: ARID1A, SMARCA2, SMARCA4, or SMARCB1. Participants aged ≥ 12 years with a body weight of ≥ 40 kilogram (kg) are acceptable for Cohorts 3. Participants with synovial sarcoma and a confirmed SS18-SSX gene fusion are also eligible.
Cohort 4: Epithelioid sarcoma with INI1 loss of expression by immunohistochemistry or SMARCB1 LOF mutation. Participants aged ≥ 12 years with a body weight of ≥ 40 kilogram (kg) are acceptable for Cohorts 4.
Cohort 5: Bladder cancer with a LOF mutation in one or more of the following genes: ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX).

Who cannot join

Have symptomatic central nervous system (CNS) malignancy or metastasis
Have symptomatic human immunodeficiency virus (HIV), Hepatitis A, B, or C
Have congestive heart failure
Are breastfeeding

Trial locations and contacts

17 sites in 5 countries.

Country

City, postcode or hospital

17 sites in 5 countries

United States7 sites

Duke University Medical Center
Durham, North Carolina, 27710
Highlands Oncology Group
Fayetteville, Arkansas, 72703
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06511
Columbia University Medical Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104

Other trials in United States

Taiwan4 sites

Taichung Veterans General Hospital
Taichung, 40705
National Cheng-Kung Uni. Hosp.
Tainan, 704
National Taiwan University Hospital
Taipei, 10048
Taipei Veterans General Hospital
Taipei, 11217

Other trials in Taiwan

France3 sites

Institut Bergonie
Bordeaux, 33076
Institut Curie
Paris, 75248
Gustave Roussy
Villejuif, 94805

Other trials in France

Spain2 sites

Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Madrid Norte Sanchinarro
Madrid, 28050

Other trials in Spain

Canada1 site

Princess Margaret Hospital
Toronto, Ontario, M5TY 2M9

Other trials in Canada

About this study

Official title: A Phase 1a/1b Study of LY3405105 Administered to Patients With Advanced Solid Tumors

Conditions: Solid Tumor
Being tested: LY3405105

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3405105Drug
Administered orally.

Study groups in NCT03770494
Study group	Role	What they receive
LY3405105	Experimental	This study was designed to be conducted in two phases: Phase 1a: This is a dose-escalation phase with a starting dose of LY3405105 1 milligram (mg) once daily (Part A1) or 2 mg three times per week (Part A2) on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason. Each dose-level will be determined and will have participants enrolled to it based on dose-limiting toxicity rate observed at previous dose-level. Intermediate, alternate, or higher dose levels will be explored if deemed necessary. Phase 1b: This is a dose-expansion phase designed to explore the anti-tumor activity of recommended LY3405105 dose and dosing schedule determined in phase 1a, in participants with multiple tumor types. [Phase 1b was planned but not initiated based on the sponsor's decision and limited efficacy observed in phase 1a] Receives: Drug: LY3405105

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1a: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT is a clinically significant adverse event that is possibly related to the study drug and fulfils any one of the following criteria using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.0:
1. Nonhematologic Grade ≥3 toxicity, except nausea, constipation, diarrhoea, vomiting or electrolyte disturbance lasting for <72 hours and can be controlled with treatment, fatigue/anorexia lasting for <5 days, transient grade 3 elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), without evidence of other hepatic injury; 2) Total bilirubin >2×upper limit of normal (ULN) with ALT/AST >3×ULN in the absence of cholestasis (alkaline phosphatase <2×ULN); 3) Grade 4 neutropenia >5 days duration, Any febrile neutropenia, Grade 4 thrombocytopenia of any duration, Grade 3 thrombocytopenia with clinically significant bleeding, Grade 3/4 anemia or any other significant toxicity deemed to be dose limiting by investigators.
Measured: Cycle 1 (Up To 28 Days)
Phase 1b: Objective Response Rate (ORR): Percentage of Participants With a Confirmed Complete Response (CR) or Partial Response (PR)
ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
Measured: Baseline through Measured Progressive Disease (Estimated up to 6 Months)

Secondary outcomes (10)

Phase 1a (Part A1): Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY3405105
AUC(0-24) of LY3405105
Measured: Cycle 1 Day 1 (Predose, 1, 2, 4, 6, 8, 24 hours post-dose)
Phase 1a (Part A1): PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC(Tau)] of LY3405105
AUC of LY3405105 during one dosing interval of 24 hours [tau = 24 hours].
Measured: Cycle 1 Day 15 (Predose, 1, 2, 4, 6, 8, 24 hours post-dose)
Phase 1a (Part A2): PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3405105
AUC(0-∞) of LY3405105.
Measured: Cycle 1 Day 1 (Predose, 1, 2, 4, 6, 8, 24, 48 hours post-dose)
Phase 1a (Part A2): PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC(Tau)] of LY3405105
AUC of LY3405105 during one dosing interval of 48 hours [tau = 48 hours].
Measured: Cycle 1 Day 15 (Predose, 1, 2, 4, 6, 8, 24, 48 hours post-dose)
Phase 1a: Objective Response Rate (ORR): Percentage of Participants With a Confirmed Complete Response (CR) or Partial Response (PR)
ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
Measured: Baseline through Measured Progressive Disease (Up To 349 Days)
Phase 1a: Disease Control Rate (DCR): Percentage of Participants Who Exhibit Stable Disease (SD), Confirmed CR or PR
DCR is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Measured: Baseline through Measured Progressive Disease (Up To 349 Days)
Phase 1a: Duration of Response (DOR)
DoR will be calculated only for responders. It is measured from the date of first evidence of a confirmed CR or PR response to the date of first progression of disease or the date of death due to any cause, whichever is earlier.
Measured: Date of Confirmed CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
Phase 1a: Time to Response (TTR)
TTR is defined as the time from the date of start of treatment to the date measurement criteria for confirmed CR or PR (whichever is first recorded) are first met.
Measured: Baseline to Date of Confirmed CR or PR (Estimated up to 6 Months)
Phase 1b: Progression Free Survival (PFS)
PFS is defined as the time from the date of start of treatment to the first date of radiologically documented progressive disease or the date of death due to any cause, whichever occurs first.
Measured: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
Phase 1b: Overall Survival (OS)
OS is defined as the time from the date of start of treatment to the date of death due to any cause.
Measured: Baseline to Date of Death from Any Cause (Estimated up to 12 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 20194 Feb 2021

First posted10 Dec 2018
Study start31 Jan 2019
Primary completion4 Feb 2021
Study completion4 Feb 2021

Why it stopped: The study was terminated for lack of sufficient efficacy.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Solid TumorStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03770494
Sponsor's protocol ID: 17125
Other IDs: J1F-MC-JZFA, 2018-002668-23, 2018
Status last verified: Oct 2025
First submitted: 7 Dec 2018
Last updated: 4 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Garralda E, Schram AM, Bedard PL, Schwartz GK, Yuen E, McNeely SC, Ribeiro S, Cunningham J, Wang Y, Urunuela A, Xu X, LoRusso P. A Phase I Dose-Escalation Study of LY3405105, a Covalent Inhibitor of Cyclin-Dependent Kinase 7, Administered to Patients With Advanced Solid Tumors. Oncologist. 2024 Jan 5;29(1):e131-e140. doi: 10.1093/oncolo/oyad215.
PubMed 37531083
Sava GP, Fan H, Coombes RC, Buluwela L, Ali S. CDK7 inhibitors as anticancer drugs. Cancer Metastasis Rev. 2020 Sep;39(3):805-823. doi: 10.1007/s10555-020-09885-8.
PubMed 32385714

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1a/1b Study of LY3405105 Administered to Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT03770494
Acronym / sponsor ID: 17125
Conditions: Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated for lack of sufficient efficacy.
Enrolment: 54 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 31 Jan 2019 (actual)
Primary completion: 4 Feb 2021 (actual)
Study completion: 4 Feb 2021 (actual)
First posted: 10 Dec 2018 (actual)
Results: Posted 4 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LY3405105	Experimental	Drug: LY3405105This study was designed to be conducted in two phases: Phase 1a: This is a dose-escalation phase with a starting dose of LY3405105 1 milligram (mg) once daily (Part A1) or 2 mg three times per week (Part A2) on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason. Each dose-level will be determined and will have participants enrolled to it based on dose-limiting toxicity rate observed at previous dose-level. Intermediate, alternate, or higher dose levels will be explored if deemed necessary. Phase 1b: This is a dose-expansion phase designed to explore the anti-tumor activity of recommended LY3405105 dose and dosing schedule determined in phase 1a, in participants with multiple tumor types. [Phase 1b was planned but not initiated based on the sponsor's decision and limited efficacy observed in phase 1a]

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Have histological or cytological evidence of a diagnosis of a solid tumor cancer that is advanced and/or metastatic
Have available archived tissue for exploratory biomarker analysis
Have adequate organ function
Have discontinued all previous treatments for cancer and recovered from their side effects
Are able to swallow capsules/tablets

Key exclusion criteria (4 listed)

Have symptomatic central nervous system (CNS) malignancy or metastasis
Have symptomatic human immunodeficiency virus (HIV), Hepatitis A, B, or C
Have congestive heart failure
Are breastfeeding

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
LY3405105Administered orally.	Drug	LY3405105

Primary outcome

Phase 1a: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 (Up To 28 Days)
A DLT is a clinically significant adverse event that is possibly related to the study drug and fulfils any one of the following criteria using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.0: 1) Nonhematologic Grade ≥3 toxicity, except nausea, constipation, diarrhoea, vomiting or electrolyte disturbance lasting for <72 hours and can be controlled with treatment, fatigue/anorexia lasting for <5 days, transient grade 3 elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), without evidence of other hepatic injury; 2) Total bilirubin >2×upper limit of normal (ULN) with ALT/AST >3×ULN in the absence of cholestasis (alkaline phosphatase <2×ULN); 3) Grade 4 neutropenia >5 days duration, Any febrile neutropenia, Grade 4 thrombocytopenia of any duration, Grade 3 thrombocytopenia with clinically significant bleeding, Grade 3/4 anemia or any other significant toxicity deemed to be dose limiting by investigators.
Phase 1b: Objective Response Rate (ORR): Percentage of Participants With a Confirmed Complete Response (CR) or Partial Response (PR)
Time frame: Baseline through Measured Progressive Disease (Estimated up to 6 Months)
ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.

10 secondary outcomes

Phase 1a (Part A1): Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY3405105
Time frame: Cycle 1 Day 1 (Predose, 1, 2, 4, 6, 8, 24 hours post-dose)
Phase 1a (Part A1): PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC(Tau)] of LY3405105
Time frame: Cycle 1 Day 15 (Predose, 1, 2, 4, 6, 8, 24 hours post-dose)
Phase 1a (Part A2): PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3405105
Time frame: Cycle 1 Day 1 (Predose, 1, 2, 4, 6, 8, 24, 48 hours post-dose)
Phase 1a (Part A2): PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC(Tau)] of LY3405105
Time frame: Cycle 1 Day 15 (Predose, 1, 2, 4, 6, 8, 24, 48 hours post-dose)
Phase 1a: Objective Response Rate (ORR): Percentage of Participants With a Confirmed Complete Response (CR) or Partial Response (PR)
Time frame: Baseline through Measured Progressive Disease (Up To 349 Days)
Phase 1a: Disease Control Rate (DCR): Percentage of Participants Who Exhibit Stable Disease (SD), Confirmed CR or PR
Time frame: Baseline through Measured Progressive Disease (Up To 349 Days)
Phase 1a: Duration of Response (DOR)
Time frame: Date of Confirmed CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
Phase 1a: Time to Response (TTR)
Time frame: Baseline to Date of Confirmed CR or PR (Estimated up to 6 Months)
Phase 1b: Progression Free Survival (PFS)
Time frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
Phase 1b: Overall Survival (OS)
Time frame: Baseline to Date of Death from Any Cause (Estimated up to 12 Months)

Results and safety

Results posted to the registry on 4 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A1 Cohort 1 (1 mg, QD)	4	2
Part A1 Cohort 2 (2 mg, QD)	4	1
Part A1 Cohort 3 (4 mg, QD)	4	2
Part A1 Cohort 4 (8 mg, QD)	4	2
Part A1 Cohort 5 (15 mg, QD)	5	1
Part A1 Cohort 6 (30 mg, QD)	5	1
Part A1 Cohort 7 (45 mg, QD)	5	2
Part A1 Cohort 8 (35 mg, QD)	3	1
Part A1 Cohort 9 (25 mg, QD)	3	0
Part A1 Cohort 10 (20 mg, QD)	6	1
Part A2 Cohort 1 (2 mg, TIW)	4	2
Part A2 Cohort 2 (4 mg, TIW)	4	2
Part A2 Cohort 3 (8 mg, TIW)	3	3
Phase 1b	0	0

Primary outcome: Phase 1a: Number of Participants With Dose Limiting Toxicities (DLTs)

Time frame: Cycle 1 (Up To 28 Days). Count of participants. Unit: Participants

Measure	Part A1 Cohort 1 (1 mg, QD) n = 4	Part A1 Cohort 2 (2 mg, QD) n = 4	Part A1 Cohort 3 (4 mg, QD) n = 4	Part A1 Cohort 4 (8 mg, QD) n = 4	Part A1 Cohort 5 (15 mg, QD) n = 5	Part A1 Cohort 6 (30 mg, QD) n = 5	Part A1 Cohort 7 (45 mg, QD) n = 5	Part A1 Cohort 8 (35 mg, QD) n = 3	Part A1 Cohort 9 (25 mg, QD) n = 3	Part A1 Cohort 10 (20 mg, QD) n = 6	Part A2 Cohort 1 (2 mg, TIW) n = 4	Part A2 Cohort 2 (4 mg, TIW) n = 4	Part A2 Cohort 3 (8 mg, TIW) n = 3
Value	0	0	0	0	0	0	3	3	1	0	0	0	0

Population analysed: All phase 1a participants who received at least one dose of LY3405105 in Cycle 1.

Primary outcome: Phase 1b: Objective Response Rate (ORR): Percentage of Participants With a Confirmed Complete Response (CR) or Partial Response (PR)

Time frame: Baseline through Measured Progressive Disease (Estimated up to 6 Months)

Population analysed: ORR is phase 1b primary outcome measure. Phase 1b of the study is not conducted and no participant enrolled, thus no data collected.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to Follow-up (Up To 690 Days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A1 Cohort 1 (1 mg, QD)	2 of 4 (50%)	4 of 4 (100%)	2 of 4
Part A1 Cohort 2 (2 mg, QD)	1 of 4 (25%)	4 of 4 (100%)	1 of 4
Part A1 Cohort 3 (4 mg, QD)	0 of 4 (0%)	4 of 4 (100%)	2 of 4
Part A1 Cohort 4 (8 mg, QD)	0 of 4 (0%)	4 of 4 (100%)	2 of 4
Part A1 Cohort 5 (15 mg, QD)	0 of 5 (0%)	4 of 5 (80%)	1 of 5
Part A1 Cohort 6 (30 mg, QD)	1 of 5 (20%)	5 of 5 (100%)	1 of 5
Part A1 Cohort 7 (45 mg, QD)	2 of 5 (40%)	5 of 5 (100%)	2 of 5
Part A1 Cohort 8 (35 mg, QD)	3 of 3 (100%)	3 of 3 (100%)	1 of 3
Part A1 Cohort 9 (25 mg, QD)	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Part A1 Cohort 10 (20 mg, QD)	1 of 6 (16.7%)	6 of 6 (100%)	1 of 6
Part A2 Cohort 1 (2 mg, TIW)	2 of 4 (50%)	3 of 4 (75%)	2 of 4
Part A2 Cohort 2 (4 mg, TIW)	0 of 4 (0%)	4 of 4 (100%)	3 of 4
Part A2 Cohort 3 (8 mg, TIW)	0 of 3 (0%)	3 of 3 (100%)	3 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37531083Garralda E, Schram AM, Bedard PL, Schwartz GK, Yuen E, McNeely SC, Ribeiro S, Cunningham J, Wang Y, Urunuela A, Xu X, LoRusso P. A Phase I Dose-Escalation Study of LY3405105, a Covalent Inhibitor of Cyclin-Dependent Kinase 7, Administered to Patients With Advanced Solid Tumors. Oncologist. 2024 Jan 5;29(1):e131-e140. doi: 10.1093/oncolo/oyad215.
Derived from this study: PubMed 32385714Sava GP, Fan H, Coombes RC, Buluwela L, Ali S. CDK7 inhibitors as anticancer drugs. Cancer Metastasis Rev. 2020 Sep;39(3):805-823. doi: 10.1007/s10555-020-09885-8.
A Study of LY3405105 in Participants With Advanced CancerLink provided by the sponsor.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

17 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3405105 in people with Solid Tumor, run by Eli Lilly and Company at 17 sites in 5 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 12 inclusion and 4 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: stopped early, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Taiwan, France, Spain, Canada. 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?

Yes. Results are posted in the registry (first posted 4 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a: Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Cycle 1 (Up To 28 Days)). The study lists 2 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 NCT03770494, which also lists 2 linked publications.

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 2025.