This study will test the safety and effectiveness of a drug called IM-1617 in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have two parts. Part A will test increasing doses of IM-1617 to find out the safe dose and schedule of IM-1617 for participants. Part B will use the dose and schedule found in Part A to further study the safety of IM-1617 and if it works to treat solid tumor cancers.
This is a Phase 1 open-label, multicenter, dose escalation and expansion study designed to determine the safety, tolerability, PK, and preliminary antitumor activity of IM-1617 administered to participants with unresectable locally advanced or metastatic solid tumors. The study consists of 2 parts: Part A: A dose-escalation phase to evaluate the safety and tolerability of IM-1617 to determine the recommended dose for expansion (RDE), evaluate maximum tolerated dose, and maximum achievable dose of IM-1617 in up to approximately 75 participants. Part B: An expansion phase to further evaluate the safety and preliminary antitumor activity of IM-1617 monotherapy at the RDE and one or more other dose regimens in up to 4 indication-specific cohorts. Up to approximately 100 participants will be enrolled in Part B.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
175
IM-1617 is an antibody-drug conjugate
Yale Cancer Center
New Haven, Connecticut, United States
RECRUITINGFlorida Cancer Specialists & Research Institute - Sarasota Cattlemen
Sarasota, Florida, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGNEXT Dallas
Irving, Texas, United States
RECRUITINGEvaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of adverse events (AEs) and serious adverse events (SAEs)
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of AEs of interest (AEIs)
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of AEs leading to discontinuation
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Evaluate the safety and tolerability of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by incidence of death
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Characterize the PK of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by area under the concentration-time curve (AUC)
Pharmacokinetic (PK) parameter
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Characterize the PK of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by maximum observed concentration (Cmax)
PK parameter
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Characterize the PK of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by time to maximum observed concentration (Tmax)
PK parameter
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Characterize the PK of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors by trough concentration (Ctrough)
PK parameter
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Characterize the immunogenicity of IM-1617
Incidence of antidrug antibodies (ADA)
Time frame: Through 30 days after last dose of study treatment; approximately 12 months
Evaluate the preliminary antitumor activity of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator
Time frame: From start of study until disease progression by RECIST v1.1 or initiation of subsequent anticancer therapy; up to approximately 12 months
Evaluate the preliminary antitumor activity of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors
Complete Response Rate (CRR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator
Time frame: From start of study until disease progression by RECIST v1.1 or initiation of subsequent anticancer therapy; up to approximately 12 months
Evaluate the preliminary antitumor activity of IM-1617 in participants with unresectable locally advanced or metastatic solid tumors
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator
Time frame: From start of study until disease progression by RECIST v1.1 or initiation of subsequent anticancer therapy; up to approximately 12 months
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