Colorectal Cancer study: IM-1617
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?
an investigational antibody‑drug conjugate being studied as a potential treatment for colorectal cancer and other solid tumors is designed to deliver a cell‑killing drug directly to cancer cells by binding to a target on the tumor surface
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 is testing whether IM-1617 is safe and works in solid tumor cancers.
- Who it's for
- You may be able to join if you have metastatic or unresectable solid tumor cancer such as colorectal, lung, breast, esophageal, or stomach cancer.
- What's involved
- You will take the study drug, first in increasing amounts, then at the dose found safe. You will visit the clinic for safety checks and tests.
- Time commitment
- The study lasts several months and includes multiple clinic visits during treatment.
- 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
- CRC, all subtypes
- Non-squamous cell carcinoma subtypes, such as adenocarcinoma
- Squamous cell carcinoma subtype
- Triple-negative breast cancer
You likely can't join if
- Previously treated with an antibody-drug conjugate (ADC) with a topoisomerase-1 (TOP1) inhibitor payload.
- 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
- CRC, all subtypes
- Non-squamous cell carcinoma subtypes, such as adenocarcinoma
- Squamous cell carcinoma subtype
- Triple-negative breast cancer
- HR+, HER2- subtype
- Adenocarcinoma subtype
- Other histologies, if approved by the Medical Monitor, which may include: head and neck squamous cell carcinoma; cervical cancer; bladder cancer
- 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
- 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.
- 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 were given in the adjuvant setting, disease must have progressed within 6 months after completing therapy.
- Participants must not have received more than 3 prior lines of systemic therapy (excluding targeted therapies for actionable biomarkers).
- 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 were given in the adjuvant setting, disease must have progressed within 6 months after completing therapy.
- Participants must not have received more than 2 prior lines of systemic therapy (excluding targeted therapies for actionable biomarkers).
- 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.
- 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 definitive/curative therapy, has had no evidence of recurrence and has negligible risk...
The study team makes the final eligibility decision.
Where it is enrolling
- New Haven, Connecticut, United States
- Sarasota, Florida, United States
- Boston, Massachusetts, United States
- Houston, Texas, 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, but 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?
This study is enrolling now at New Haven, Connecticut, United States; Sarasota, Florida, United States; Boston, Massachusetts, United States; Houston, Texas, United States; Irving, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.