A Phase 1 Study of IM-1340 in Participants With Advanced Malignancies

Study Identifier:
IM-1340-101
CT.gov Identifier:
NCT07890246
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

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-1340 administered to participants with advanced solid tumors. The study consists of 2 parts:

Part A: A dose-escalation phase to evaluate the safety and tolerability of IM-1340 to determine the recommended dose for expansion (RDE) and evaluate maximum tolerated dose (MTD) and/or maximum achievable dose.

Part B: An expansion phase to further evaluate the safety and preliminary antitumor activity of IM-1340 monotherapy.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Small Cell Lung
Neuroendocrine
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: IM-1340 Dose Escalation
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • Inclusion Criteria:
  • * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
  • * Histological diagnosis including but not limited to one of the following advanced solid tumors:
  • * Part A
  • * Extended stage small cell lung cancer (ES-SCLC)
  • * High-grade neuroendocrine neoplasms (NENs)
  • * G3 neuroendocrine tumor (NET) and neuroendocrine carcinoma (NEC, pulmonary and extrapulmonary)
  • * Non-squamous non-small cell lung cancer (NSCLC)
  • * Colorectal cancer
  • * Part B
  • * Cohort B1: ES-SCLC
  • * Cohort B2: Non-squamous NSCLC
  • * Other Part B cohorts: Cohort-specific disease indication may include those listed under Part A above
  • * Participants must have disease that is considered to be incurable and meet the appropriate criteria below:
  • * Part A:
  • * ES-SCLC: Participants must have received, or be ineligible to receive, prior platinum-based chemotherapy and a programmed cell death-1/programmed death-ligand 1 (PD-\[L\]1) monoclonal antibody.
  • * Other tumor types, with Medical Monitor approval: Participants must have received, or be ineligible to receive, available SOC treatments, or have no satisfactory SOC treatment options available.
  • * Part B:
  • * Cohort B1 (ES-SCLC):
  • * Participants must have received, or be ineligible to receive, prior platinum-based chemotherapy and a PD-\[L\]1 monoclonal antibody.
  • * Cohort B2 (non-sq NSCLC):
  • * Participants must have previously received, or be ineligible to receive, platinum-based chemotherapy and a PD-\[L\]1 monoclonal antibody. Participants with a known actionable biomarker(s) must have been treated with at least one prior appropriate available targeted therapy.
  • * Other Part B cohorts: Criteria will be specified based on the disease indications selected.
  • * Participants must have measurable disease as per RECIST v1.1
  • * Participants must have adequate organ function.
Exclusion criteria
  • Exclusion Criteria:
  • * Previously treated with an ADC with a DNA topoisomerase inhibitor (TOP1) payload
  • * Note: Participants with non-squamous NSCLC who have received up to one prior ADC with a TOP1 inhibitor payload are eligible. Participants with other tumor types previously treated with an ADC with a TOP1 inhibitor payload may be eligible if approved by the Medical Monitor.
  • * History of an anaphylactic reaction to TOP1 inhibitors or TOP1-inhibiting ADCs.
  • * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • * Known history of another primary malignancy, unless the participant has undergone potentially curative therapy with no evidence of recurrence and/or negligible risk of metastatic disease and death and consulted with the Medical Monitor.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Los Angeles
Los Angeles, CA, United States, 90025
Investigator
Navid Hafez
Status
Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Small Cell Lung
Neuroendocrine