NeoplasmsPhase 1NCT01346358

A Study of IMC-CS4 in Subjects With Advanced Solid Tumors

A Phase 1 study testing IMC-CS4 in people with Neoplasms, run by Eli Lilly and Company at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A dose escalation study to establish the safety profile and characterize the pharmacokinetic profile of IMC-CS4 in the treatment of subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy is available. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms
What is being tested?: IMC-CS4
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 6 sitesUnited States
Study dates: 15 Jun 2011to 31 May 2018
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

Subject has histologic or cytologic confirmation of advanced solid tumors that is refractory to standard therapy or for which no standard therapy is available
Subject has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Subject has resolution to grade ≤1 by NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.03 of all clinically significant toxic effects of prior treatment
Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Subject has adequate hematologic, hepatic, renal, and coagulation function
Subject has a life expectancy greater than 3 months
Subject agrees to use adequate contraception during the study period and for 12 weeks after last dose of study therapy
Subject must undergo mandatory biopsies, including one pretreatment and one post treatment tumor biopsy procedure

Who cannot join

Subject has experienced acute pathologic fracture or spinal cord compression within 28 days prior to first dose of study therapy
Subject has a known hypersensitivity to monoclonal antibodies or to agents of similar biologic composition as IMC-CS4.
Subject has received treatment with any monoclonal antibodies within 4 weeks prior to first dose of study therapy
Subject has undergone a major surgical procedure, open biopsy, radiofrequency ablation or has experienced a significant injury within 28 days prior to enrollment
Subject has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or in situ neoplasm
Subject has an ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, active bleeding or any other serious uncontrolled medical disorder

Show all 13Show fewer

Subject has known or suspected primary brain or leptomeningeal metastases
Subject has leukemia or lymphoma
Subject is know to have active tuberculosis, leishmaniasis, or listeriosis
Subjects with known history, or clinical or laboratory evidence of liver disease
Subject has a known active hepatitis B or C infection, Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
Subject if female, is pregnant or breastfeeding
Subject has received an organ transplant

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Emory University
Atlanta, Georgia, 30322
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-5055
Ohio State University Medical Center
Columbus, Ohio, 43210
The Angeles Clinic & Research Institute
Los Angeles, California, 90025
Columbia University College of Phys & Surgeons
New York, New York, 10032
Univ of California San Francisco
San Francisco, California, 94115

Other trials in United States

About this study

Official title: Phase 1 Study of IMC-CS4, a Monoclonal Antibody Targeted to the CSF-1 Receptor (CSF-1R), In Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy is Available

Conditions: Neoplasms
Being tested: IMC-CS4
Keywords: Advanced Solid Tumors
Medical subject headings: Neoplasms

What participants receive

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

IMC-CS4Biological
Also called LY3022855

Study groups in NCT01346358
Study group	Role	What they receive
IMC-CS4 Weight Based Dosing	Experimental	Participants received 2.5 mg/kg once weekly (QW), 0.3 mg/kg QW, 0.6 mg/kg QW, 1.25 mg/kg every two weeks (Q2W) and1.25 mg/kg QW of IMC CS4 by intravenous infusion in Part A. Receives: Biological: IMC-CS4
IMC-CS4 Non-Weight Based Dosing	Experimental	Participants received 100 mg QW, 100 mg QW on weeks 1, 2, 4 and 5 and 150 mg QW of IMC CS4 by intravenous infusion in Part B. Receives: Biological: IMC-CS4

What is being measured

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

Pharmacokinetics (PK) - Maximum Concentration (Cmax) of IMC-CS4
Pharmacokinetics (PK) - Maximum concentration (Cmax) of IMC-CS4.
Measured: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1
Pharmacokinetics - Minimum Concentration (Cmin) of IMC-CS4
Pharmacokinetics - Minimum concentration (Cmin) of IMC-CS4.
Measured: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1
Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4
Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4.
Measured: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1
Pharmacokinetics - Volume of Distribution at Steady State (Vss) of IMC-CS4
Pharmacokinetics - Volume of distribution at steady state (Vss) of IMC-CS4.
Measured: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1
Pharmacokinetics -Clearance (Cl) of IMC-CS4
Pharmacokinetics -Clearance (Cl) of IMC-CS4.
Measured: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1

Secondary outcomes (2)

Recommend Phase 2 Dose (RP2D) of IMC-CS4
The recommended Phase 2 dose was the highest dose where less than 1/3 of participants experienced dose limiting toxicities (DLTs). A DLT is defined as an adverse event (AE) occurring during Cycle 1 that fulfilled 1 of the following criteria: Any Common Terminology Criteria for Adverse Events (CTCAE), version (v) 4.0 Grade 4 neutropenia lasting ≥ 7 days, Grade 3 or 4 neutropenia complicated by fever ≥38.0°C or infection, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia complicated by hemorrhage, Grade 3 or 4 anemia, Grade ≥3 AST/ALT elevation, Grade ≥2 AST/ALT elevation and Grade ≥2 bilirubin elevation and Grade 3 or 4 nonhematologic toxicity. A summary of other nonserious AEs and all Serious Adverse Events (SAE), regardless of causality is located in the Reported Adverse Event section.
Measured: Cycle 1 (6 Days)
Percentage of Participants With Anti-IMC-CS4 Antibody Assessment
The overall percentage of participants with treatment-emergent positive for anti-IMC-CS4 antibodies during the study. Participants were considered positive for anti-IMC-CS4 antibodies if they exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the normal anti-IMC-CS4 level seen in healthy untreated individuals.
Measured: Up To 6 Months

Timeline

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

15 Jun 201131 May 2018

First posted3 May 2011 (estimated)
Study start15 Jun 2011
Primary completion31 May 2018
Study completion31 May 2018

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 (1)Papers the sponsor has linked to this study.
Other trials for 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01346358
Sponsor's protocol ID: 14311
Other IDs: CP24-1001, I5F-IE-JSCA
Status last verified: May 2024
First submitted: 29 Apr 2011
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Dowlati A, Harvey RD, Carvajal RD, Hamid O, Klempner SJ, Kauh JSW, Peterson DA, Yu D, Chapman SC, Szpurka AM, Carlsen M, Quinlan T, Wesolowski R. LY3022855, an anti-colony stimulating factor-1 receptor (CSF-1R) monoclonal antibody, in patients with advanced solid tumors refractory to standard therapy: phase 1 dose-escalation trial. Invest New Drugs. 2021 Aug;39(4):1057-1071. doi: 10.1007/s10637-021-01084-8. Epub 2021 Feb 23.
PubMed 33624233

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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RecruitingPhase 2
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RecruitingPhase 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
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All Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1 Study of IMC-CS4, a Monoclonal Antibody Targeted to the CSF-1 Receptor (CSF-1R), In Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy is Available
ClinicalTrials.gov ID: NCT01346358
Acronym / sponsor ID: 14311
Conditions: Neoplasms
Keywords: Advanced Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 15 Jun 2011 (actual)
Primary completion: 31 May 2018 (actual)
Study completion: 31 May 2018 (actual)
First posted: 3 May 2011 (estimated)
Results: Posted 19 Sep 2024

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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IMC-CS4 Weight Based Dosing	Experimental	Biological: IMC-CS4Participants received 2.5 mg/kg once weekly (QW), 0.3 mg/kg QW, 0.6 mg/kg QW, 1.25 mg/kg every two weeks (Q2W) and1.25 mg/kg QW of IMC CS4 by intravenous infusion in Part A.
IMC-CS4 Non-Weight Based Dosing	Experimental	Biological: IMC-CS4Participants received 100 mg QW, 100 mg QW on weeks 1, 2, 4 and 5 and 150 mg QW of IMC CS4 by intravenous infusion in Part B.

Who may qualify

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

Key inclusion criteria (8 listed)

Subject has histologic or cytologic confirmation of advanced solid tumors that is refractory to standard therapy or for which no standard therapy is available
Subject has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Subject has resolution to grade ≤1 by NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.03 of all clinically significant toxic effects of prior treatment
Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Subject has adequate hematologic, hepatic, renal, and coagulation function

Key exclusion criteria (13 listed)

Subject has experienced acute pathologic fracture or spinal cord compression within 28 days prior to first dose of study therapy
Subject has a known hypersensitivity to monoclonal antibodies or to agents of similar biologic composition as IMC-CS4.
Subject has received treatment with any monoclonal antibodies within 4 weeks prior to first dose of study therapy
Subject has undergone a major surgical procedure, open biopsy, radiofrequency ablation or has experienced a significant injury within 28 days prior to enrollment
Subject has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or in situ neoplasm

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
IMC-CS4Also: LY3022855	Biological	IMC-CS4 Non-Weight Based Dosing, IMC-CS4 Weight Based Dosing

Primary outcome

Pharmacokinetics (PK) - Maximum Concentration (Cmax) of IMC-CS4
Time frame: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1
Pharmacokinetics (PK) - Maximum concentration (Cmax) of IMC-CS4.
Pharmacokinetics - Minimum Concentration (Cmin) of IMC-CS4
Time frame: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1
Pharmacokinetics - Minimum concentration (Cmin) of IMC-CS4.
Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4
Time frame: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1
Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4.
Pharmacokinetics - Volume of Distribution at Steady State (Vss) of IMC-CS4
Time frame: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1
Pharmacokinetics - Volume of distribution at steady state (Vss) of IMC-CS4.
Pharmacokinetics -Clearance (Cl) of IMC-CS4
Time frame: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1
Pharmacokinetics -Clearance (Cl) of IMC-CS4.

2 secondary outcomes

Recommend Phase 2 Dose (RP2D) of IMC-CS4
Time frame: Cycle 1 (6 Days)
Percentage of Participants With Anti-IMC-CS4 Antibody Assessment
Time frame: Up To 6 Months

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 (2.5 Milligram Per Kilogram (mg/kg) QW)	6	4
Cohort 2 (0.3 mg/kg QW)	4	3
Cohort 3 (0.6 mg/kg QW)	3	2
Cohort 4 (1.25 mg/kg Q2W)	6	5
Cohort 4 Expanded (1.25 mg/kg Q2W)	5	4
Cohort 5 (1.25 mg/kg QW)	5	3
Cohort 6a (100 mg QW)	3	2
Cohort 6a Expanded (100 mg QW)	11	7
Cohort 7a (150 mg QW)	9	6

Primary outcome: Pharmacokinetics (PK) - Maximum Concentration (Cmax) of IMC-CS4

Time frame: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: Microgram/milliliters (µg/mL)

Measure	2.5 mg/kg of IMC-CS4 QW n = 6	0.3 mg/kg of IMC-CS4 QW n = 4	0.6 mg/kg of IMC-CS4 QW n = 3	1.25 mg/kg of IMC-CS4 QW n = 5	1.25 mg/kg of IMC-CS4 Q2W n = 10	100 mg of IMC-CS4 QW n = 14	150 mg of IMC-CS4 QW n = 8
Cycle 1 Day 1	69.2 (13)	6.83 (32)	13.5 (33)	26.0 (14)	31.2 (24)	32.2 (25)	42.9 (20)
Cycle 1 Day 15	–	–	–	–	30.0 (25)	–	–
Cycle 1 Day 22	92.7 (23)	–	–	–	–	–	–
Cycle 3 Day 1	–	–	–	–	–	42.8 (59)	NA (NA)

Population analysed: All enrolled participants who received at least one dose of study drug and have evaluable PK data for Cmax.

Primary outcome: Pharmacokinetics - Minimum Concentration (Cmin) of IMC-CS4

Time frame: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: µg/mL

Measure	2.5 mg/kg of IMC-CS4 QW n = 6	0.3 mg/kg of IMC-CS4 QW n = 0	0.6 mg/kg of IMC-CS4 QW n = 0	1.25 mg/kg of IMC-CS4 QW n = 2	1.25 mg/kg of IMC-CS4 Q2W n = 5	100 mg of IMC-CS4 QW n = 9	150 mg of IMC-CS4 QW n = 8
Cycle 1 Day 1	14.4 (34)	–	–	NA (NA)	3.32 (11)	3.77 (79)	5.15 (81)
Cycle 1 Day 15	–	–	–	–	3.35 (22)	–	–
Cycle 1 Day 22	29.9 (36)	–	–	–	–	–	–
Cycle 3 Day 1	–	–	–	–	–	21.9 (86)	NA (NA)

Population analysed: All enrolled participants who received at least one dose of study drug and have evaluable PK data for Cmin.

Primary outcome: Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4

Time frame: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: Hours* microgram per mL (h*µg/mL)

Measure	2.5 mg/kg of IMC-CS4 QW n = 6	0.3 mg/kg of IMC-CS4 QW n = 3	0.6 mg/kg of IMC-CS4 QW n = 3	1.25 mg/kg of IMC-CS4 QW n = 5	1.25 mg/kg of IMC-CS4 Q2W n = 10	100 mg of IMC-CS4 QW n = 14	150 mg of IMC-CS4 QW n = 8
Cycle 1 Day 1	5020 (18)	256 (14)	492 (23)	1810 (21)	1550 (50)	1780 (43)	2810 (34)
Cycle 1 Day 15	–	–	–	–	1700 (49)	–	–
Cycle 1 Day 22	11300 (18)	–	–	–	–	–	–
Cycle 3 Day 1	–	–	–	–	–	4430 (80)	NA (NA)

Population analysed: All enrolled participants who received at least one dose of study drug and have evaluable PK data for AUC.

Primary outcome: Pharmacokinetics - Volume of Distribution at Steady State (Vss) of IMC-CS4

Time frame: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: Liters (L)

Measure	2.5 mg/kg of IMC-CS4 QW n = 6	0.3 mg/kg of IMC-CS4 QW n = 3	0.6 mg/kg of IMC-CS4 QW n = 3	1.25 mg/kg of IMC-CS4 QW n = 5	1.25 mg/kg of IMC-CS4 Q2W n = 10	100 mg of IMC-CS4 QW n = 14	150 mg of IMC-CS4 QW n = 8
Cycle 1 Day 1	4.80 (40)	4.61 (4)	3.21 (12)	4.85 (8)	3.59 (24)	4.12 (14)	4.87 (26)
Cycle 1 Day 15	–	–	–	–	3.47 (19)	–	–
Cycle 1 Day 22	6.11 (10)	–	–	–	–	–	–
Cycle 3 Day 1	–	–	–	–	–	4.84 (60)	NA (NA)

Population analysed: All enrolled participants who received at least one dose of study drug and have evaluable PK data for Vss.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up To 6 Months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 (2.5 mg/kg QW)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Cohort 2 (0.3 mg/kg QW)	1 of 4 (25%)	4 of 4 (100%)	2 of 4
Cohort 3 (0.6 mg/kg QW)	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3
Cohort 4 (1.25 mg/kg Q2W)	2 of 6 (33.3%)	6 of 6 (100%)	1 of 6
Cohort 4 Expanded (1.25 mg/kg Q2W)	2 of 5 (40%)	4 of 5 (80%)	1 of 5
Cohort 5 (1.25 mg/kg QW)	3 of 5 (60%)	3 of 5 (60%)	1 of 5
Cohort 6a (100 mg QW)	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Cohort 6a Expanded (100 mg QW)	4 of 11 (36.4%)	11 of 11 (100%)	2 of 11
Cohort 7a (150 mg QW)	3 of 9 (33.3%)	9 of 9 (100%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33624233Dowlati A, Harvey RD, Carvajal RD, Hamid O, Klempner SJ, Kauh JSW, Peterson DA, Yu D, Chapman SC, Szpurka AM, Carlsen M, Quinlan T, Wesolowski R. LY3022855, an anti-colony stimulating factor-1 receptor (CSF-1R) monoclonal antibody, in patients with advanced solid tumors refractory to standard therapy: phase 1 dose-escalation trial. Invest New Drugs. 2021 Aug;39(4):1057-1071. doi: 10.1007/s10637-021-01084-8. Epub 2021 Feb 23.
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

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMC-CS4 in people with Neoplasms, run by Eli Lilly and Company at 6 sites in United States.

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 8 inclusion and 13 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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 19 Sep 2024). 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?

Pharmacokinetics (PK) - Maximum Concentration (Cmax) of IMC-CS4 (time frame: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1). The study lists 5 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 NCT01346358, 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 19 Sep 2024.