Advanced Solid TumorsPhase 1NCT00635778

A Dose-finding Study of Dalotuzumab in Subjects With Advanced Solid Tumors (MK-0646-002)

A Phase 1 study testing dalotuzumab in people with Advanced Solid Tumors, run by Merck Sharp & Dohme LLC.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors
What is being tested?: dalotuzumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: No sites listed yet
Study dates: 7 Aug 2006to 5 Nov 2008
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

Males and females with advanced solid tumors who have failed to respond to standard therapy, ages 18 years and older, with adequate organ function

Who cannot join

Participant is using growth hormones or growth hormone inhibitors
Participant is known to be allergic to components of the drug or similar drugs (e.g. monoclonal antibodies such as rituximab or biological therapies such as immunoglobulin G
Participant has had chemotherapy, radiotherapy, or biological therapy within 4-6 weeks of entering the study or has not recovered from previous therapy
Participant is taking part in or has taken part in a study of an investigational compound or device within 30 days of their first dose of study drug
Participant has an active Central Nervous System metastases and/or carcinomatous meningitis. However, a participant who has completed a course of therapy and is clinically stable may be able to participate
Participant is pregnant or breastfeeding

Show all 10Show fewer

Participant is human immunodeficiency virus (HIV) positive
Participant has a history of Hepatitis B or C
Participant has symptomatic ascites or pleural effusion. However, if the participant has received treatment and is stable, they may be able to participate
Female participant plans to become pregnant or a male participant who plans to impregnate their partner during the time the study is ongoing

About this study

Official title: An Open-Label, Dose Escalation Phase I Trial of MK-0646 Given as a One to Two Hour Every Other Week Infusion in Patients With Relapsed or Refractory Locally Advanced or Metastatic Cancers

The study determined the recommended Phase 2 loading and maintenance doses and dose schedules for administering dalotuzumab using dose-limiting toxicities (DLTs) observed during the entire treatment period (Up to 18 months). The primary hypothesis of the study was that administration of dalotuzumab as an every other week infusion in participants with relapsed or refractory locally advanced or metastatic cancers associated with a high frequency of insulin-like growth factor receptor type 1(IGF-1R) overexpression will be generally safe and well tolerated to permit further study and achieve a constant clearance and a minimum trough concentration of 3 µg/mL.

Read the detailed description

The study consisted of 3 parts. In Part 1 the loading dose was escalated while the maintenance dose was kept constant. In Part 2 the loading dose was kept constant while the maintenance dose was escalated. In Part 3 the recommended phase 2 loading and maintenance doses and schedule were administered to an expanded cohort to explore safety and efficacy of dalotuzumab.

Conditions: Advanced Solid Tumors
Being tested: dalotuzumab

What participants receive

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

dalotuzumabDrug
Also called MK-0646
Administered as an IV infusion over one to two hours

Study groups in NCT00635778
Study group	Role	What they receive
dalotuzumab 2.5/2.5 mg/kg	Experimental	Participants received a loading dose of dalotuzumab 2.5 mg/kg administered by intravenous (IV) infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months. Receives: Drug: dalotuzumab
dalotuzumab 5.0/5.0 mg/kg	Experimental	Participants received a loading dose of dalotuzumab 5.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months. Receives: Drug: dalotuzumab
dalotuzumab 10.0/5.0 mg/kg	Experimental	Participants received a loading dose of dalotuzumab 10.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months. Receives: Drug: dalotuzumab
dalotuzumab 15.0/5.0mg/kg	Experimental	Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months. Receives: Drug: dalotuzumab
dalotuzumab 20.0/5.0 mg/kg	Experimental	Participants received a loading dose of dalotuzumab 20.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months. Receives: Drug: dalotuzumab
dalotuzumab 15.0/10.0 mg/kg	Experimental	Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 10.0 mg/kg administered by IV infusion every two weeks for up to 18 months. Receives: Drug: dalotuzumab
dalotuzumab 15.0/15.0 mg/kg	Experimental	Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 15.0 mg/kg administered by IV infusion every two weeks for up to 18 months. Receives: Drug: dalotuzumab

What is being measured

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

Steady-state Serum Concentration of Dalotuzumab at 336 Hours (C336) After the First Maintenance Dose
Blood samples were obtained for analysis of steady-state serum concentration of dalotuzumab at 336 hours (C336) after the first maintenance dose of dalotuzumab. The C336 of dalotuzumab after intravenous administration is presented.
Measured: 2 weeks post first maintenance dose of study drug (3 weeks post loading dose of study drug)
Number of Participants Who Experience One or More Dose- Limiting Toxicities (DLTs)
Dose-limiting toxicities (DLT) were assessed and graded using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE). A DLT was defined as the occurrence of any of the following events, that were judged by the study investigator, to be related to the study medication: Grade 4 neutropenia; Grade 3 neutropenia with fever >38.5 degrees Celsius; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity (except alopecia and inadequately treated diarrhea, nausea, and vomiting, and hyperglycemia lasting less than 5 days; and Grade 3 or greater hyperglycemia lasting for more than 5 days in spite of optimal medical management.
Measured: The entire treatment period (Up to 18 months)

Secondary outcomes (16)

Number of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)
Complete Response (disappearance of all target lesions) or Partial Response (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) using Response Criteria in Solid Tumors (RECIST). Tumor response was assessed prior to first dose and every 8 weeks beginning pre-dose of Week 9 for up to 18 months. The best response out of all measurements for each participant was used for determining CR and PR.
Measured: Up to 18 months post first dose of study drug
Percent Change From Baseline in Serum Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Level at Week 1
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Measured: Baseline and Week 1
Number of Participants With a Positive Human-anti-humanized-antibody (HAHA) Titer
The formation of HAHAs may block efficacy by prematurely clearing dalotuzumab and limit the possibility of future dalotuzumab therapy. Blood samples for the measurement of serum levels of HAHAs were obtained prior to treatment with dalotuzumab, and pre-dose Week 3, Week 5, pre-dose every 8 subsequent weeks, and end of treatment (post-study: 4 weeks after last dose of study drug). Positive HAHA status for a participant is defined as testing positive on both the screening and immunodepletion assays at one or more visits.
Measured: Prior to second and subsequent doses of study drug (Up to 1 year post-first dose)
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 5
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Measured: Baseline and Week 5
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 9
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Measured: Baseline and Week 9
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 13
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Measured: Baseline and Week 13
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 17
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Measured: Baseline and Week 17
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 21
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Measured: Baseline and Week 21
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 25
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Measured: Baseline and Week 25
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 29
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Measured: Baseline and Week 29
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 33
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Measured: Baseline and Week 33
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 37
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Measured: Baseline and Week 37
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 41
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Measured: Baseline and Week 41
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 45
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Measured: Baseline and Week 45
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 49
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Measured: Baseline and Week 49
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 53
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Measured: Baseline and Week 53

Timeline

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

7 Aug 20065 Nov 2008

First posted14 Mar 2008 (estimated)
Study start7 Aug 2006
Primary completion5 Nov 2008
Study completion5 Nov 2008

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.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00635778
Sponsor's protocol ID: 0646-002
Other IDs: MK-0646-002
Status last verified: Feb 2018
First submitted: 29 Feb 2008
Last updated: 9 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Dose Escalation Phase I Trial of MK-0646 Given as a One to Two Hour Every Other Week Infusion in Patients With Relapsed or Refractory Locally Advanced or Metastatic Cancers
ClinicalTrials.gov ID: NCT00635778
Acronym / sponsor ID: 0646-002
Conditions: Advanced Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 7 Aug 2006 (actual)
Primary completion: 5 Nov 2008 (actual)
Study completion: 5 Nov 2008 (actual)
First posted: 14 Mar 2008 (estimated)
Results: Posted 9 Oct 2018

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
dalotuzumab 2.5/2.5 mg/kg	Experimental	Drug: dalotuzumabParticipants received a loading dose of dalotuzumab 2.5 mg/kg administered by intravenous (IV) infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months.
dalotuzumab 5.0/5.0 mg/kg	Experimental	Drug: dalotuzumabParticipants received a loading dose of dalotuzumab 5.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
dalotuzumab 10.0/5.0 mg/kg	Experimental	Drug: dalotuzumabParticipants received a loading dose of dalotuzumab 10.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
dalotuzumab 15.0/5.0mg/kg	Experimental	Drug: dalotuzumabParticipants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
dalotuzumab 20.0/5.0 mg/kg	Experimental	Drug: dalotuzumabParticipants received a loading dose of dalotuzumab 20.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
dalotuzumab 15.0/10.0 mg/kg	Experimental	Drug: dalotuzumabParticipants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 10.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
dalotuzumab 15.0/15.0 mg/kg	Experimental	Drug: dalotuzumabParticipants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 15.0 mg/kg administered by IV infusion every two weeks for up to 18 months.

Who may qualify

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

Key inclusion criteria (1 listed)

Males and females with advanced solid tumors who have failed to respond to standard therapy, ages 18 years and older, with adequate organ function

Key exclusion criteria (10 listed)

Participant is using growth hormones or growth hormone inhibitors
Participant is known to be allergic to components of the drug or similar drugs (e.g. monoclonal antibodies such as rituximab or biological therapies such as immunoglobulin G
Participant has had chemotherapy, radiotherapy, or biological therapy within 4-6 weeks of entering the study or has not recovered from previous therapy
Participant is taking part in or has taken part in a study of an investigational compound or device within 30 days of their first dose of study drug
Participant has an active Central Nervous System metastases and/or carcinomatous meningitis. However, a participant who has completed a course of therapy and is clinically stable may be able to participate

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
dalotuzumabAlso: MK-0646Administered as an IV infusion over one to two hours	Drug	dalotuzumab 10.0/5.0 mg/kg, dalotuzumab 15.0/10.0 mg/kg, dalotuzumab 15.0/15.0 mg/kg, dalotuzumab 15.0/5.0mg/kg, dalotuzumab 2.5/2.5 mg/kg, dalotuzumab 20.0/5.0 mg/kg, dalotuzumab 5.0/5.0 mg/kg

Primary outcome

Steady-state Serum Concentration of Dalotuzumab at 336 Hours (C336) After the First Maintenance Dose
Time frame: 2 weeks post first maintenance dose of study drug (3 weeks post loading dose of study drug)
Blood samples were obtained for analysis of steady-state serum concentration of dalotuzumab at 336 hours (C336) after the first maintenance dose of dalotuzumab. The C336 of dalotuzumab after intravenous administration is presented.
Number of Participants Who Experience One or More Dose- Limiting Toxicities (DLTs)
Time frame: The entire treatment period (Up to 18 months)
Dose-limiting toxicities (DLT) were assessed and graded using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE). A DLT was defined as the occurrence of any of the following events, that were judged by the study investigator, to be related to the study medication: Grade 4 neutropenia; Grade 3 neutropenia with fever >38.5 degrees Celsius; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity (except alopecia and inadequately treated diarrhea, nausea, and vomiting, and hyperglycemia lasting less than 5 days; and Grade 3 or greater hyperglycemia lasting for more than 5 days in spite of optimal medical management.

16 secondary outcomes

Number of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)
Time frame: Up to 18 months post first dose of study drug
Percent Change From Baseline in Serum Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Level at Week 1
Time frame: Baseline and Week 1
Number of Participants With a Positive Human-anti-humanized-antibody (HAHA) Titer
Time frame: Prior to second and subsequent doses of study drug (Up to 1 year post-first dose)
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 5
Time frame: Baseline and Week 5
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 9
Time frame: Baseline and Week 9
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 13
Time frame: Baseline and Week 13
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 17
Time frame: Baseline and Week 17
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 21
Time frame: Baseline and Week 21
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 25
Time frame: Baseline and Week 25
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 29
Time frame: Baseline and Week 29
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 33
Time frame: Baseline and Week 33
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 37
Time frame: Baseline and Week 37
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 41
Time frame: Baseline and Week 41
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 45
Time frame: Baseline and Week 45
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 49
Time frame: Baseline and Week 49
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 53
Time frame: Baseline and Week 53

Results and safety

Results posted to the registry on 9 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dalotuzumab 2.5 mg/kg / Dalotuzumab 2.5 mg/kg	1	0
Dalotuzumab 5.0 mg/kg / Dalotuzumab 5.0 mg/kg	3	0
Dalotuzumab 10.0 mg/kg / Dalotuzumab 5.0 mg/kg	3	0
Dalotuzumab 15.0 mg/kg / Dalotuzumab 5.0 mg/kg	8	0
Dalotuzumab 20.0 mg/kg / Dalotuzumab 5.0 mg/kg	8	0
Dalotuzumab 15.0 mg/kg / Dalotuzumab 10.0 mg/kg	21	0
Dalotuzumab 15.0 mg/kg / Dalotuzumab 15.0 mg/kg	6	0

Primary outcome: Steady-state Serum Concentration of Dalotuzumab at 336 Hours (C336) After the First Maintenance Dose

Time frame: 2 weeks post first maintenance dose of study drug (3 weeks post loading dose of study drug). Mean (Standard Deviation). Unit: μg/mL

Measure	Dalotuzumab 2.5 mg/kg / Dalotuzumab 2.5 mg/kg n = 1	Dalotuzumab 5.0 mg/kg / Dalotuzumab 5.0 mg/kg n = 2	Dalotuzumab 10.0 mg/kg / Dalotuzumab 5.0 mg/kg n = 3	Dalotuzumab 15.0 mg/kg / Dalotuzumab 5.0 mg/kg n = 6	Dalotuzumab 20.0 mg/kg / Dalotuzumab 5.0 mg/kg n = 8	Dalotuzumab 15.0 mg/kg / Dalotuzumab 10.0 mg/kg n = 19	Dalotuzumab 15.0 mg/kg / Dalotuzumab 15.0 mg/kg n = 5
Value	4.78 (NA)	7.48 (8.50)	54.57 (24.64)	33.00 (24.90)	25.95 (26.22)	24.39 (27.63)	86.73 (44.56)

Population analysed: All participants who received dalotuzumab and had blood samples drawn for pharmacokinetic (PK) analyses.

Primary outcome: Number of Participants Who Experience One or More Dose- Limiting Toxicities (DLTs)

Time frame: The entire treatment period (Up to 18 months). Count of participants. Unit: Participants

Measure	Dalotuzumab 2.5 mg/kg / Dalotuzumab 2.5 mg/kg n = 1	Dalotuzumab 5.0 mg/kg / Dalotuzumab 5.0 mg/kg n = 3	Dalotuzumab 10.0 mg/kg / Dalotuzumab 5.0 mg/kg n = 3	Dalotuzumab 15.0 mg/kg / Dalotuzumab 5.0 mg/kg n = 8	Dalotuzumab 20.0 mg/kg / Dalotuzumab 5.0 mg/kg n = 8	Dalotuzumab 15.0 mg/kg / Dalotuzumab 10.0 mg/kg n = 21	Dalotuzumab 15.0 mg/kg / Dalotuzumab 15.0 mg/kg n = 6
Value	0	0	0	0	0	0	1

Population analysed: All participants who received at least one dose of study drug.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 19 months (up to 18 months of treatment with study drug plus 1 month of follow-up). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dalotuzumab 2.5 mg/kg / Dalotuzumab 2.5 mg/kg	1 of 1 (100%)	1 of 1 (100%)	0 of 1
Dalotuzumab 5.0 mg/kg / Dalotuzumab 5.0 mg/kg	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3
Dalotuzumab 10.0 mg/kg / Dalotuzumab 5.0 mg/kg	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Dalotuzumab 15.0 mg/kg / Dalotuzumab 5.0 mg/kg	5 of 8 (62.5%)	8 of 8 (100%)	1 of 8
Dalotuzumab 20.0 mg/kg / Dalotuzumab 5.0 mg/kg	6 of 8 (75%)	8 of 8 (100%)	1 of 8
Dalotuzumab 15.0 mg/kg / Dalotuzumab 10.0 mg/kg	9 of 21 (42.9%)	21 of 21 (100%)	1 of 21
Dalotuzumab 15.0 mg/kg / Dalotuzumab 15.0 mg/kg	3 of 6 (50%)	6 of 6 (100%)	1 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing dalotuzumab in people with Advanced Solid Tumors, run by Merck Sharp & Dohme LLC.

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 1 inclusion and 10 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 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

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 9 Oct 2018). 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?

Steady-state Serum Concentration of Dalotuzumab at 336 Hours (C336) After the First Maintenance Dose (time frame: 2 weeks post first maintenance dose of study drug (3 weeks post loading dose of study drug)). 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 NCT00635778.

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 9 Oct 2018.