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New treatment option for Colorectal Cancer
Official title A Phase 1 Study of IM-1617 in Participants With Advanced Cancer
ClinicalTrials.gov ID: NCT07578571
What this study is testing
What is IM-1617?
IM-1617 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Part A: Histological diagnosis of one of the following unresectable locally advanced or metastatic solid tumors:
- CRC, all subtypes
- NSCLC:
- Non-squamous cell carcinoma subtypes, such as adenocarcinoma
You likely can't join if
- Previously treated with an antibody-drug conjugate (ADC) with a topoisomerase-1 (TOP1) inhibitor payload. Exception: Participants with NSCLC or...
- History of anaphylactic reaction to TOP1 inhibitors (e.g., irinotecan) or TOP1 inhibiting ADCs
- Life expectancy \< 12 weeks
- Prior solid organ transplant
- Symptomatic ascites or pleural effusion
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
See the full eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Part A: Histological diagnosis of one of the following unresectable locally advanced or metastatic solid tumors:
- CRC, all subtypes
- NSCLC:
- Non-squamous cell carcinoma subtypes, such as adenocarcinoma
- Squamous cell carcinoma subtype
- Breast cancer (subtypes based on estrogen/progesterone receptor and HER2 testing according to American Society of Clinical Oncology - College of American Pathologists guidelines):
- Triple-negative breast cancer
- HR+, HER2- subtype
- Esophageal, esophagogastric junction, and gastric cancer:
- Adenocarcinoma subtype
- Other histologies, if approved by the Medical Monitor, which may include: head and neck squamous cell carcinoma; cervical cancer; bladder cancer; squamous cell carcinoma subtype of esophageal, esophagogastric junction...
- Part B Cohorts - Histological diagnosis of one of the following unresectable locally advanced or metastatic solid tumors:
- Cohort B1: CRC, all subtypes
- Cohort B2: NSCLC
- Non-squamous cell carcinoma subtypes, such as adenocarcinoma
- Squamous cell carcinoma subtype
- Cohorts B3 and B4: Cohort-specific disease indications may include those listed for Part A
- Participants must have disease that is considered to be noncurative and meet the appropriate criteria below:
- Part A only: Participants have progressed on, were intolerant to, or have a contraindication to prior SOC treatments, with no satisfactory SOC treatment options available.
- Part B only:
- Cohort B1 (CRC):
- Participants must have previously progressed on, were intolerant to, or have a contraindication to fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, bevacizumab, and for those with RAS wild-type...
- Participants with actionable biomarkers must have been treated with at least one prior appropriate biomarker-directed therapy.
- If any of these therapies was given in the adjuvant setting, disease must have progressed within 6 months after completing therapy.
- Cohort B2 (NSCLC):
- Participants must have previously progressed on, were intolerant to, or have a contraindication to platinum-based chemotherapy and a programmed cell death-1 (PD-1)/programmed death ligand 1 (PD-L1) monoclonal antibody...
- Participants with actionable biomarkers must have been treated with at least one prior appropriate targeted therapy.
- If any of these therapies was given in the adjuvant setting, disease must have progressed within 6 months after completing therapy.
- Cohorts B3 and B4: Criteria will be specified based on the disease indications selected.
- Participants must have measurable disease as defined per RECIST v1.1
- Previously treated with an antibody-drug conjugate (ADC) with a topoisomerase-1 (TOP1) inhibitor payload. Exception: Participants with NSCLC or breast cancer may have received up to one prior ADC with a TOP1 inhibitor...
- History of anaphylactic reaction to TOP1 inhibitors (e.g., irinotecan) or TOP1 inhibiting ADCs
- Life expectancy \< 12 weeks
- Prior solid organ transplant
- Symptomatic ascites or pleural effusion
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Known history of another primary solid or hematologic malignancy (other than that under study), unless the participant has undergone potentially curative therapy with no evidence of recurrence for at least 2 years and...
The study team makes the final eligibility decision.
Where it's taking place
- Sarasota, Florida, United States
- Irving, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sarasota, Florida, United States; Irving, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.