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RecruitingPhase 1

A Phase 1 Study of IM-1617 in Participants With Advanced Cancer

A Phase 1 Study of IM-1617 in Participants With Advanced Malignancies

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of IM-1617 and how well it treats solid tumor cancers that have spread or cannot be removed with surgery. Part A will find a safe dose and treatment schedule. Part B will use that dose and schedule to learn more about safety and whether the drug works.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You can care for yourself and are up and about for at least half the day, even if you cannot work (ECOG score 0–2).
  • Your cancer is not considered curable. It has spread nearby or to other parts of the body and cannot be removed with surgery.
  • For Part A, a tissue test must show colon or rectal cancer, non-small cell lung cancer, certain breast cancers, or certain cancers of the stomach, food pipe, or where they join. Other types may be allowed with the study medical monitor’s approval.
  • For Part B, groups B1 and B2 are for colon or rectal cancer and non-small cell lung cancer. Groups B3 and B4 may include cancers listed for Part A, with rules based on the cancer chosen.
  • For Part A, standard treatments have stopped working, caused side effects you could not tolerate, or are unsafe for you. No suitable standard treatment options remain.
  • For Part B colon or rectal cancer, required prior treatments include specific chemotherapy drugs, bevacizumab, and an EGFR-targeting drug for certain tumors. They must have stopped working, caused side effects you could not tolerate, or be unsafe for you.
  • For Part B lung cancer, platinum chemotherapy and immune treatment must have stopped working, caused side effects you could not tolerate, or be unsafe for you. For both B1 and B2, certain tumor test results require prior targeted treatment. If required treatments were given after surgery, cancer must have worsened within 6 months after treatment ended.
  • Your cancer must be measurable using the study’s rules.

Who can't join

  • You previously received an antibody-drug conjugate, a drug that carries cancer medicine to cells, containing a TOP1-blocking drug. People with non-small cell lung cancer or breast cancer may have had one such treatment.
  • You have had a severe allergic reaction called anaphylaxis to a TOP1-blocking drug, such as irinotecan, or an antibody-drug conjugate containing one.
  • You are expected to live less than 12 weeks.
  • You have had a solid organ transplant.
  • You have fluid buildup in your belly or around your lungs that causes symptoms.
  • You have known active cancer spread to the brain or spinal cord, or cancer in the tissues covering them.
  • You have had another separate solid tumor or blood cancer. An exception may apply if you had treatment aimed at curing it, it has not returned for at least 2 years, and the study medical monitor approves.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 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, and gastric cancer; HER2+ breast cancer 3. 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 4. 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 tumors, an anti-epidermal growth factor receptor (EGFR)-directed monoclonal antibody in advanced disease setting. * 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 (given concurrently or sequentially with chemotherapy) in advanced disease setting. * 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. 5. Participants must have measurable disease as defined per RECIST v1.1 Exclusion Criteria: 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 payload 2. History of anaphylactic reaction to TOP1 inhibitors (e.g., irinotecan) or TOP1 inhibiting ADCs 3. Life expectancy \< 12 weeks 4. Prior solid organ transplant 5. Symptomatic ascites or pleural effusion 6. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis 7. 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 approved by the Medical Monitor

Study sites (4)

CT

FL

MA

TX