Phase 1 Completed N=52 Treatment

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

Neoplasms

Source: ClinicalTrials.gov NCT01346358 ↗

Enrolled (actual)

Serious AEs

34.6%

Results posted

Sep 2024

Primary outcomePrimary: Pharmacokinetics (PK) - Maximum Concentration (Cmax) of IMC-CS4 — 69.2; 6.83; 13.5; 26.0 Microgram/milliliters (µg/mL)

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetics (PK) - Maximum Concentration (Cmax) of IMC-CS4	69.2; 6.83; 13.5; 26.0; 31.2; 32.2	—
PRIMARY Pharmacokinetics - Minimum Concentration (Cmin) of IMC-CS4	14.4; NA; 3.32; 3.77; 5.15; 3.35	—
PRIMARY Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4	5020; 256; 492; 1810; 1550; 1780	—
PRIMARY Pharmacokinetics - Volume of Distribution at Steady State (Vss) of IMC-CS4	4.80; 4.61; 3.21; 4.85; 3.59; 4.12	—
PRIMARY Pharmacokinetics -Clearance (Cl) of IMC-CS4	0.0379; 0.108; 0.0715; 0.0561; 0.0566; 0.0561	—
SECONDARY Recommend Phase 2 Dose (RP2D) of IMC-CS4	100	—
SECONDARY Percentage of Participants With Anti-IMC-CS4 Antibody Assessment	50; 0; 0; 0; 0; 25	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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
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

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Data sourced from ClinicalTrials.gov (NCT01346358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.